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ID Update

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APRIL 2024

Ceftobiprole Medocaril Approved

  • Ceftobiprole medocaril (Zevtera) has been approved by the US FDA for (1) adults with S. aureus bacteremia, including those with right-sided IE, caused by MSSA and MRSA, (2) adults with ABSSSI caused by MSSA, MRSA, S. pyogenes, and K. pneumoniae, and (3) adults and pediatric patients with CAP caused by MSSA (not MRSA), S. pneumoniae, H. influenzae, H. parainfluenzae, and K. pneumoniae. It is not approved for VAP. Ceftobiprole medocaril is a prodrug that is rapidly converted to ceftobiprole presumably by plasma esterases. Its spectrum of activity is similar to that of ceftaroline. Recommended dosing is 667 mg IV q6-8h (depending on the indication). 667 mg of ceftobiprole medocaril is equivalent to 500 mg of ceftobiprole.

Chikungunya Vaccine

  • Single-dose, live attenuated chikungunya virus vaccine (Ixchiq) for persons aged ≥18 years is now available in the US through the usual vaccine wholesalers.
  • Recommended for persons aged ≥18 years with travel to a country or territory with a current CDC-declared Chikungunya outbreak.
  • May be considered for certain persons traveling to non-outbreak countries or territories with transmission among humans within the past five years, as determined by CDC.
    • Persons with long-stay travel (cumulative >6 months).
    • All persons aged >65 years (especially with comorbidities) who might have at least ≥2 weeks (cumulative) exposure to mosquitoes in indoor or outdoor settings.
    • Excludes those traveling for business and likely to be mainly in mosquito-protected indoor settings.

Mpox Vaccine

  • As of April 2024, Jynneos (mpox and smallpox vaccine, live, non-replicating) is available commercially through usual vaccine wholesalers. Public health advice should be sought prior to use for smallpox prevention, also an FDA-approved indication.
  • The intradermal and subcutaneous routes of Jynneos administration are interchangeable. Persons who received dose 1 of Jynneos via the intradermal route during the mpox emergency may receive dose 2 subcutaneously. In case of another outbreak and a vaccine shortage, persons may receive dose 2 via the intradermal route regardless of route of administration of dose 1.

New Rilpivirine Pediatric Dosage Formulation

  • Rilpivirine 2.5 mg tablets for oral suspension (EDURANT PED) have been approved by the US FDA for the treatment of HIV-1 in combination with other antiretroviral therapies in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg. They must be dispersed in 5 mL water and ingested immediately (not chewed or swallowed whole). The new 2.5 mg tablets and the original 25 mg film-coated tablets differ in bioavailability and are thus not interchangeable on a mg-per-mg basis.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • New shortages:
    • Nafcillin injection (20 Mar 2024)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Shortages recently resolved:
    • Doxycycline oral suspension (22 Mar 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 14 April 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (22 Feb 2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir, all oral formulations (29 Jun 2023)
        • Cefixime 400 mg capsules (21 Jan 2022)
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details).
      • Chloramphenicol injection (9 Oct 2023)
      • Clindamycin phosphate injection (25 Jun 2015)
      • Fluoroquinolones:
        • Ciprofloxacin injection (13 Jan 2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1%
        • Erythromycin 0.5% ophthalmic ointment (8 Jul 2022)
      • Metronidazole injection (20 Oct 2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension (5 Jun 2018)
      • Penicillins:
        • Amoxicillin, all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Ampicillin injection (19 Oct 2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (1 Feb 2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (31 Mar 2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (17 May 2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (21 Sep 2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection (10 Nov 2022)
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Nystatin topical powder (18 Aug 2023)
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
      • Isoniazid injection 100 mg/mL (24 Jan 2024)
      • Rifampin capsules
    • Antiparasitic drugs:
      • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
      • Primaquine tablets 26.3 mg
    • Antiviral drugs: 
      • Acyclovir injection (21 Feb 2024)
      • Nirsevimab-alip injection (24 Oct 2023)
      • Oseltamivir capsules, powder for oral suspension (1 Nov 2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution (23 May 2023)
      • Valganciclovir tablets, powder for oral solution (7 Feb 2023)
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
    • Ritonavir oral solution 80 mg/mL (Jan 2023)

MARCH 2024

SARS-CoV-2 / COVID-19

New Rilpivirine Pediatric Dosage Formulation

  • Rilpivirine 2.5 mg tablets for oral suspension (EDURANT PED) have been approved by the US FDA for the treatment of HIV-1 in combination with other antiretroviral therapies in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg. They must be dispersed in 5 mL water and ingested immediately (not chewed or swallowed whole). The new 2.5 mg tablets and the original 25 mg film-coated tablets differ in bioavailability and are thus not interchangeable on a mg-per-mg basis.

Tuberculosis Preventive Treatment: Update from WHO

  • In a Rapid Communication, the World Health Organization (WHO) has announced a number of updates to its forthcoming 2nd edition of the guidance on tuberculosis preventive treatment (TPT). The primary update is a recommendation to use a regimen of six months of levofloxacin as TPT for contacts of patients with multidrug- or rifampin-resistant TB, based on the results of two RCTs in Vietnam and South Africa that support the use of the regimen in all age groups. Other revisions include updated drug dosages for TPT regimens with levofloxacin and rifapentine, integration of recommendations on screening strategies to rule out TB ahead of starting TPT and the use of TB tests, and an update of the algorithm for the management of TPT in contacts. The updated guidance will be released later this year. The Rapid Communication is available here.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • New shortages:
    • Acyclovir injection (21 Feb 2024)
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Shortages recently resolved:
    • Cefixime capsules 400 mg (9 Jan 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 10 Mar 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (22 Feb 2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir, all oral formulations (29 Jun 2023)
        • Cefixime 400 mg capsules (21 Jan 2022)
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details).
      • Chloramphenicol injection (9 Oct 2023)
      • Clindamycin phosphate injection (25 Jun 2015)
      • Doxycycline oral suspension (16 Nov 2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (13 Jan 2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1%
        • Erythromycin 0.5% ophthalmic ointment (8 Jul 2022)
      • Metronidazole injection (20 Oct 2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin, all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Ampicillin injection (19 Oct 2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (1 Feb 2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (31 Mar 2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (17 May 2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (21 Sep 2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection (10 Nov 2022)
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Nystatin topical powder (18 Aug 2023)
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
      • Isoniazid injection 100 mg/mL (24 Jan 2024)
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (24 Oct 2023)
      • Oseltamivir capsules, powder for oral suspension (1 Nov 2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution (23 May 2023)
      • Valganciclovir tablets, powder for oral solution (7 Feb 2023)
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
    • Ritonavir oral solution 80 mg/mL (Jan 2023)

FEBRUARY 2024

SARS-CoV-2 / COVID-19

Cefepime-Enmetazobactam Approved

  • Cefepime-enmetazobactam (Exblifep) has been approved by the US FDA for complicated UTI in adults. Enmetazobactam is a beta-lactamase inhibitor similar to tazobactam. A key structural difference improves penetration into the bacterial cell. Enmetazobactam enhances the activity of cefepime vs Ambler Class A enzymes, such as ESBLs. The recommended dosage is 2.5 gm (cefepime 2 gm + enmetazobactam 0.5 gm) IV q8h x7-14 days. Each dose is infused over 2 hours. In a recently published phase 3 RCT in patients with complicated UTI or acute pyelonephritis caused by gram-negative bacilli, cefepime-enmetazobactam (compared with piperacillin-tazobactam) met criteria for noninferiority as well as superiority with respect to the primary outcome of clinical cure and microbiologic eradication (JAMA 2022;328:1304).

CDC Syphilis Testing Recommendations

  • Approximately six million new cases of syphilis occur globally each year. A syphilis epidemic is occurring in the US, with sustained increases in primary and secondary syphilis from 5,979 cases reported in 2000 to 133,945 cases reported in 2020. This epidemic is characterized by health disparities, particularly among sexual and gender minority populations, intersections with the HIV and substance use epidemics, and increased morbidity and mortality due to congenital infection. The US CDC has published new recommendations for syphilis testing, including laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results (MMWR Recomm Rep 2024;73(1):1-35). PDF available here.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • New shortages:
    • Isoniazid injection 100 mg/mL (24 Jan 2024)
  • Shortages recently resolved:
    • Cefixime capsules 400 mg (9 Jan 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 12 Feb 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (22 Feb 2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir, all oral formulations (29 Jun 2023)
        • Cefixime 400 mg capsules (21 Jan 2022)
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details).
      • Chloramphenicol injection (9 Oct 2023)
      • Clindamycin phosphate injection (25 Jun 2015)
      • Doxycycline oral suspension (16 Nov 2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (13 Jan 2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1%
        • Erythromycin 0.5% ophthalmic ointment (8 Jul 2022)
      • Metronidazole injection (20 Oct 2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin. all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Ampicillin injection (19 Oct 2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (1 Feb 2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (31 Mar 2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (17 May 2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (21 Sep 2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection (10 Nov 2022)
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Nystatin topical powder (18 Aug 2023)
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (24 Oct 2023)
      • Oseltamivir capsules, powder for oral suspension (1 Nov 2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution (23 May 2023)
      • Valganciclovir tablets, powder for oral solution (7 Feb 2023)
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
    • Ritonavir oral solution 80 mg/mL (Jan 2023)

JANUARY 2024

SARS-CoV-2 / COVID-19

Something New: Doxy-PEP

  • Doxycycline post-exposure prophylaxis (doxy-PEP) has been shown to reduce the incidence of gonorrhea, syphilis, and Chlamydia among cisgender MSM and transgender women who have had at least one of these STIs in the past 12 months (N Engl J Med 2023;388:1296-1306). It can be considered for such persons who have not had a recent STI but are at risk because of multiple partners. Doxy-PEP was not effective in a study conducted in cisgender women (N Engl J Med 2023;389:2331-2340), so more studies regarding its use after vaginal sex are needed. There are no data available for heterosexual, cisgender men who are at risk of STIs, nor for transgender men. Possible long-term effects of doxy-PEP include its potential impact on antibiotic resistance and alterations in the microbiome. The recommended dose of doxycycline (hyclate or monohydrate) is 200 mg orally administered within 24-72 hours of condomless sex.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 8, 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since December 8, 2023:
      • None
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (02/22/2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (6/4/2018)
        • Cefdinir, all oral formulations (6/29/2023)
        • Cefixime 400 mg capsules (1/21/2022)
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details).
      • Chloramphenicol injection (10/9/2023)
      • Clindamycin phosphate injection (6/25/2015)
      • Doxycycline oral suspension (11/16/2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (1/13/2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/2023)
        • Moxifloxacin 400 mg tablets (12/6/2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (6/1/2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment (7/8/2022)
      • Metronidazole injection (10/20/2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin. all oral formulations (10/18/2022)
        • Amoxicillin-clavulanate, all oral formulations
        • Ampicillin injection (10/19/2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (2/1/2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (3/31/2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (5/17/2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (03/31/2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection (10/10/2022)
      • Amphotericin B Lipid Complex
      • Nystatin topical powder (08/18/2023)
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (10/24/2023)
      • Oseltamivir capsules, powder for oral suspension (11/01/2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (December 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)

DECEMBER 2023

SARS-CoV-2 / COVID-19

Expanded Clofazimine Access

  • Clofazimine (Lamprene) has been unavailable in US pharmacies since 2004. Currently, individuals with leprosy may obtain access to clofazimine from the National Hansen's Disease Program. Under certain circumstances, patients may be able to obtain access to clofazimine for the treatment of non-tuberculous mycobacterial (NTM) infections or other infections (uses for which clofazimine does not have FDA approval) from Novartis. Click here for more information.

CDC Immunization Schedules

  • The 2024 US CDC recommended immunization schedules and associated footnotes are updated annually by the US Centers for Disease Control and Prevention (CDC). Beginning with the 2024 schedule, the final version for the upcoming year will be published online in November of the previous year. This is about three months earlier than previously to allow for supply chain and payor coordination for any changes.  

Updated Anthrax Guidelines

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since November 12, 2023:
      • Moxifloxacin 400 mg tablets (12/6/2023)
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (02/22/2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (6/4/2018)
        • Cefdinir, all oral formulations (6/29/2023)
        • Cefixime 400 mg capsules (1/21/2022)
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details).
      • Chloramphenicol injection (10/9/2023)
      • Clindamycin phosphate injection (6/25/2015)
      • Doxycycline oral suspension (11/16/2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (1/13/2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (6/1/2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment (7/8/2022)
      • Metronidazole injection (10/20/2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Ampicillin injection (10/19/2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (2/1/2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (3/31/2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (5/17/2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (03/31/2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection (10/10/2022)
      • Amphotericin B Lipid Complex (ABLC)
      • Nystatin topical powder
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (10/24/2023)
      • Oseltamivir capsules, powder for oral suspension (11/01/2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

NOVEMBER 2023

SARS-CoV-2 / COVID-19

Vaccine for Chikungunya Virus

  • Single dose, live attenuated virus vaccine (Ixchiq, Valneva) for age >18 years now FDA approved.
    • Vaccine efficacy trial to be done in Phase 4 with readouts by 2027.
    • Recommended for: Adults with travel to areas with current CDC declared outbreaks.
    • Consider for: Certain persons traveling to transmission areas (within past 5 years as determined by CDC).
      • Long-stay travel (>6 months).
      • All persons age >65 years especially with co-morbidities.
    • FDA specified sero-response rate met in 98.9% of non-endemic subjects with 12-month persistence in pivotal Phase 3 trial (Lancet 2023; 401:P2138).
    • Adverse effects: Headache (31.6%), fatigue (28.5%), myalgia (23.9%), arthralgia (17.2%), fever (13.5%), nausea (11.2%).
    • Severe adverse effects: Chikungunya-like illness in 1.6%. 
    • US CDC ACIP draft proposal (vote in February 2024).

New Meningococcal Vaccine

  • A new combination meningococcal vaccine MenABCWY (Penbraya, Pfizer) has been approved by the US FDA and ACIP recommendations made. Penbraya may be used when both MenACWY and MenB are indicated at the same visit and desired by the patient. Common situations will include:
    • Healthy persons age 16-23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and the person is already due for the age 16 dose of MenACWY.
    • Persons age >10 years at increased risk of meningococcal disease (e.g., due to persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia) due for both vaccines at the same visit.
  • In most situations the second dose of MenB-containing vaccine will need to be with Trumenba (MenB monovalent vaccine). This combination vaccine introduces many complexities into the quite different MenACWY and MenB schedules.

Composition of Future Influenza Vaccine

  • Quadrivalent influenza vaccines protect against four different viruses: one H1N1 virus, one H3N2 virus, one B/Victoria virus and one B/Yamagata virus. All current influenza vaccines in the US are quadrivalent. US CDC and global surveillance data show that B/Yamagata lineage viruses have not been detected since March 2020, perhaps a result of the widespread public health countermeasures imposed during the COVID-19 pandemic. After review of these data, the WHO Influenza Vaccine Composition Advisory Committee and US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) have recommended that B/Yamagata lineage antigens be removed from influenza vaccines used in the US and internationally as soon as reasonably possible. For further information from CDC regarding the 2023-24 influenza season, click here.

Fexinidazole Availability

  • Fully FDA-approved fexinidazole tablets (Sanofi), the treatment of choice for West African trypanosomiasis due to both Stage 1 and 2 T. brucei gambiense infection, are now available in the US. The fully oral regimen replaces the need for the previous regimen that includes a week of IV Eflornithine (stocked only by CDC). However, with Stage 2 disease with WBC >100/µL in CSF, the older regimen must still be used. Contact Sanofi directly (no commercial distribution) for free drug: Sanofi Medical Affairs at 1-800-372-6634 or customersupport@sanofi.com.

Mpox Update

  • For Mpox prevention, CDC has moved from earlier outbreak-based recommendations to standing recommendations.
  • Persons >18 years of age with risk factors should receive two doses of Jynneos 28 days apart. Jynneos will move to commercial distribution in the next few months.
  • Persons at risk:
    • Gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past six months have had one of the following:
      • At least one sexually transmitted disease
      • More than one sex partner
      • Sex at a commercial sex venue
      • Sex in association with a large public event in a geographic area where mpox transmissions is occurring
    • Sexual partners of persons with the risks described above
    • Persons who anticipate experiencing any of the above
    • Persons deemed at risk by health authorities in outbreak situations
  • Pregnancy: No recommendation at present, but pregnant persons with risk factors as above MAY receive Jynneos.
  • Healthcare workers: Should not receive Jynneos unless they have a sexual risk factor as above.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 12, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since October 8, 2023:
      • Ampicillin injection (10/19/2023)
      • Chloramphenicol injection (10/9/2023)
      • Nirsevimab-alip injection (10/24/2023)
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefdinir (all oral formulations)
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/23)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/23)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
      • Nystatin topical powder
    • Antimycobacterial drugs: 
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

OCTOBER 2023

CDC Health Alert Network

  • October 23: Health Advisory issued to provide options for clinicians to protect infants from RSV in the context of a limited supply of nirsevimab-alip. Click here for complete advisory, here for Sanofi press release.

SARS-CoV-2 / COVID-19

COVID-19 Vaccination Summary

  • US guidelines have shifted to annual universal vaccination as of September 2023 because:
    1. Persons of any age and health status have at least some measurable risk of severe illness.
    2. Co-morbid conditions that increase the risk of severe illness are widespread.
  • CDC guidelines refer to "2023-24 COVID vaccine" with no preferred product (Modern, Pfizer, Novavax) regardless of past vaccine history. One dose of 2023-4 vaccine is indicated for all persons ≥6 months of age as soon as vaccine is available.
  • A full primary series is no longer indicated for healthy persons >5 years of age as almost the entire US population has antibody against SARS-CoV-2 from previous infection or vaccination.
  • All US persons age >6 months should be up-to-date on vaccination regardless of:
    • A history of symptomatic or asymptomatic SARS-CoV-2 infection;
    • Presence of long COVID;
    • History of SARS-CoV-2 breakthrough infection.
  • In short, a normal host age ≥5 years is up-to-date after receipt of one updated COVID-19 vaccine, regardless of the number of previous doses of mRNA or Janssen/J&J vaccine. Healthy children age 6 months to 4 years are up-to-date after receipt of all recommended primary mRNA doses (two Moderna or three Pfizer) including at least one dose of updated COVID-19 vaccine.
  • Defer vaccination until recovery from an acute episode and discontinuation of isolation. After SARS-CoV-2 infection, consider delaying next dose by three months from symptom onset or positive test.
  • There are no human efficacy data for the 2023-4 vaccine, but there is a documented boost in neutralizing antibody titers (only against current strains).
  • Observational data from recent bivalent vaccine indicates approximate effectiveness against hospitalization of about 50% in close proximity to the date of vaccine receipt.
  • WHO COVID-19 vaccination recommendations:
    • WHO recommends a simplified single-dose regimen for primary immunization, with eligibility determined by national priorities for most COVID-19 vaccines.
    • When monovalent XBB vaccines are not available, any available WHO- approved vaccine, bivalent variant-containing or monovalent index virus vaccines, may be used since they continue to provide benefits against severe disease in high-risk groups.

    ACIP Maternal RSV Recommendations

    • Of the two available RSV vaccines, only Abrysvo (Pfizer) is FDA approved for maternal prenatal vaccination at 32-36 weeks gestation to protect infants with passive antibody.
      • ACIP recommends seasonal administration of a single dose of Abrysvo for pregnant persons who are between 32-36 weeks gestation during the period of September to January to passively protect babies born between October and March as an equal option to nirsevimab-alip (Beyfortus) given to infants for their first RSV season.
        • In Alaska, parts of Florida, Hawaii, Puerto Rico, the U.S. Virgin Islands, and Guam, RSV can circulate year round. The seasonal rule for use of the vaccine would not apply in these areas.
    • When applicable, ACIP recommends seasonal administration of Abrysvo as an equal option to postnatal nirsevimab-alip. At other times of year, outside the maternal indications for Abyrsvo, nirsevimab-alip given to infants would be the only option.
    • Administration of both nirsevimab-alip to an infant and Abrysvo to the mother provides no benefit over administration of one or the other, but may be considered if the mother is immunocompromised or the infant has especially high RSV risk.  
    • Infants born <34 weeks gestation, or if the mother was vaccinated but the infant was born <14 days after vaccination, are recommended to receive nirsevimab-alip.
    • Abrysvo is about half the cost of nirsevimab-alip, but the effect does not appear to last as long (three months for Abrsyvo).
    • The complexities in choice of approach are likely to cause confusion among both patients and providers.

    Other Vaccine Recommendations from CDC

    Approved: Metronidazole Oral Suspension

    • The US FDA has approved metronidazole oral suspension (Likmez) for the treatment of trichomoniasis in adults, amebiasis in adult and pediatric patients, and anaerobic bacterial infections in adults. Product availability: 200 mL bottle, 500 mg/5 mL, strawberry-peppermint flavor. Refrigeration is not required.

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since September 14, 2023:
            • Levofloxacin oral solution, 25 mg/mL (9/15/23)
            • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/23)
          • Shortage recently resolved:
            • Isoniazid injection, 100 mg/mL (9/23/2023)
            • Neomycin 500 mg tablets (9/7/2023)
            • Tedizolid injection (10/2/2023)
            • Tedizolid phosphate 200 mg tablets (10/2/2023)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Nystatin topical powder
          • Antimycobacterial drugs: 
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

        SEPTEMBER 2023

        SARS-CoV-2 / COVID-19

        From CDC

        • 2023-2024 ACIP seasonal influenza vaccine recommendations (MMWR Recomm Rep 2023;72:1-28). PDF here.
        • 2023 ACIP recommendations for the use of pneumococcal vaccines in adults age ≥19 years (MMWR Recomm Rep 2023;72:1-39). PDF here.

        Second Indication for Abrysvo

        • The unadjuvanted, bivalent RSV vaccine Abrysvo was approved in August 2023 for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age.
          • ACIP guidelines are pending regarding preference vs. postnatal nirsevimab-alip for infants.
          • Concern exists regarding excess premature births in trials.
        • FDA news release here.

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of September 14, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since August 6, 2023:
            • Nystatin topical powder
          • Shortage recently resolved:
            • Neomycin 500 mg tablets (9/7/2023)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
            • Tedizolid phosphate injection
            • Tedizolid phosphate 200 mg tablets
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs: 
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

        AUGUST 2023

        SARS-CoV-2 / COVID-19

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 6, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since July 10, 2023:
            • Tedizolid injection
          • Shortage recently resolved:
            • Azithromycin injection
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
            • Tedizolid 200 mg tablets
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs: 
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

        JULY 2023

        SARS-CoV-2 / COVID-19

        US Approval of Nirsevimab-alip

        • The US FDA has approved nirsevimab-alip (brand name Beyfortus), a monoclonal antibody that provides passive immunization against respiratory syncytial virus (RSV) by targeting the prefusion conformation of the fusion (F) glycoprotein. It is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Safety and efficacy are supported by three clinical trials. Nirsevimab has been available in the European Union since October 31, 2022. It will be available in the US ahead of the upcoming 2023-2024 RSV season.
        • Dosage for neonates and infants born during or entering their first RSV season:
          • Body weight at time of dosing <5 kg: 50 mg IM x1
          • Body weight at time of dosing ≥5 kg: 100 mg IM x1
        • Dosage for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season:
          • 200 mg IM x1, administered as two 100 mg injections
        • Product availability: Prefilled syringes, 50 mg/0.5 mL and 100 mg/mL
        • See FDA news release here.

        New Product for Molluscum Contagiosum

        • The US FDA has approved cantharidin 0.7% topical solution (brand name Ycanth) for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is the first FDA-approved treatment for molluscum. Health care providers are to apply a single application to each lesion every three weeks as needed. See FDA news release here.

        US Approval of Anthrax Vaccine Adsorbed, Adjuvanted

        • Cyfendus, an adjuvanted formulation of Biothrax, has been FDA approved for PEP only (not PrEP).
        • Cyfendus eliminates the need for a third dose at 4 weeks for PEP.  Concomitant antibiotics are still necessary.
        • This vaccine simplifies the response to a large-scale public health emergency involving anthrax.
        • 3 million doses of Cyfendus (labelled AV7909) are already in US government stockpiles.
        • Detailed guidelines for use are pending ACIP recommendations, but dose and timing will be per FDA labeling.
        • See Anthrax, Vaccine page for more information.

        Locally Acquired Malaria in the US

        • CDC issued a Health Advisory (CDCHAN-00494) to share information regarding five US residents (four in Florida, one in Texas) diagnosed with locally-acquired, mosquito-transmitted Plasmodium vivax. In the US, most cases of malaria are diagnosed in people who have traveled to an endemic region. Locally acquired mosquito-borne malaria has not occurred in the US since 2003. Despite these cases, the risk of locally acquired malaria remains extremely low.

        RSV Vaccine: Key Points

        • The CDC Advisory Committee on Immunization Practices (ACIP) now advises that adults aged ≥60 years MAY receive a single IM dose of a respiratory syncytial virus (RSV) vaccine with either Abrysvo (Pfizer; unadjuvanted) or Arexvy (GSK; uses same adjuvant as Shingrix), using shared clinical decision-making. Immunocompromised persons SHOULD be vaccinated even if such individuals were not included in the clinical trials.
        • Both vaccines demonstrated significant vaccine effectiveness against RSV induced lower respiratory tract infection among older adults that lasted over at least 2 consecutive seasons; a second dose after 1 year conferred no additional protection. Data were insufficient (few cases in placebo group) to determine statistically significant vaccine effectiveness in persons aged ≥75 years or against hospitalization. Co-administration with all types of influenza vaccine appears safe without statistically significant effect on vaccine effectiveness for either vaccine, although titers for each vaccine were somewhat lower. Availability of both vaccines is anticipated for the 2023-24 winter RSV season (mid-September through mid-May; peaks late December to mid-February). Vaccination is recommended as soon as vaccine becomes available. Cost is expected to be USD 180-270 for Abrysvo and USD 200-295 for Arexvy.
        • A review of the prevalence, clinical characteristics, and outcomes of RSV infections vs. influenza in adults hospitalized with acute respiratory illness over a three-year period suggests that outcomes are worse in persons with RSV, and they frequently have underlying cardiopulmonary conditions (Clin Infect Dis 2023;76:1980).

        New Clinical Practice Guidelines

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of July 10, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since June 12, 2023:
            • Cefdinir (all oral formulations)
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Podofilox 0.5% topical gel
            • Tedizolid 200 mg tablets
          • Shortage recently resolved:
            • Azithromycin injection
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs: 
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

        JUNE 2023

        SARS-CoV-2 / COVID-19

        Second RSV vaccine approved

        • The US FDA has approved a second respiratory syncytial virus (RSV) vaccine (Abrysvo) for use in individuals 60 years of age and older. This unadjuvanted, bivalent vaccine is composed of equal amounts of recombinant RSV prefusion F protein from RSV subgroups A and B. Dosage is a single 0.5 mL injection. The vaccine will not be released until fall.

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of June 12, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since May 5, 2023:
            • Isoniazid injection (100 mg/mL)
            • Penicillin VK tablets (250 mg, 500 mg; 250 mg/5 mL oral solution
            • Ribavirin inhalation powder for solution
          • Shortage recently resolved:
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Penicillin G benzathine/Penicillin G procaine (Bicillin)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs: 
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

        MAY 2023

        SARS-CoV-2 / COVID-19

        US FDA Drug Approvals

        • A co-packaged product containing nirmatrelvir and ritonavir tablets (Paxlovid) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Drug manufactured and packaged under the EUA and distributed by DHHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. See FDA news release here.
        • A co-packaged product containing injectable sulbactam and durlobactam (Xacduro), for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients ≥18 years of age. Sulbactam is a beta-lactamase inhibitor with intrinisic activity against Acinetobacter baumannii; durlobactam is a beta-lactamase inhibitor which helps to prevent degradation of sulbactam by enzymes produced by A. baumannii. Recommended dosage in normal renal function is 1 gm of sulbactam and 1 gm of durlobactam IV q6h (infused over three hours). The co-packaged product was granted Priority Review and designated as a Qualified Infectious Disease Product (QIDP). Availability is expected later this year. See FDA news release here.

        COVID Vaccine Summary

        • Latest recommendations from CDC (April 19, 2023 - normal host)(May 1, 2023 - immunocompromised) are that monovalent (original) mRNA vaccines are no longer recommended in the US.
        • Almost the entire US population has antibody against SARS-CoV-2 (via previous infection or vaccination).
        • All persons >6 years of age who are unvaccinated or previously completed a monovalent primary series should receive a bivalent mRNA vaccine. No further doses are needed except persons who are >65 years of age or immunocompromised.
        • A single additional bivalent vaccine dose for adults ≥65 years, and one or more additional doses for people who are immunocompromised, are recommended.
        • Immunocompromised persons age >12 years have the option to receive one additional dose of the Moderna (0.5 mL/50 µg) or Pfizer (0.3 mL/30 µg) vaccine ≥2 months following the last recommended bivalent dose. Further additional dose(s) may be administered, informed by clinical judgment and personal preference and circumstances ≥2 months after the last vaccine dose.
        • For young children, multiple doses continue to be recommended and vary by age, vaccine, and which vaccines were previously received. See Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine.

        RSV Vaccine Approved

        • The US FDA has approved a respiratory syncytial virus (RSV) adjuvanted vaccine (Arexvy) for use in individuals 60 years of age and older. Dosage is a single 0.5 mL IM injection. The vaccine will not be released until fall. See FDA news release here.

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 5, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since April 8, 2023:
            • None
          • Shortage recently resolved:
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefixime 400 mg capsules
              • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Penicillin G benzathine/Penicillin G procaine (Bicillin)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs: 
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs: 
            • Isoniazid 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
          • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
          • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
          • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
          • Bacitracin injection (February 2020)
          • Interferon alfa-2b (Intron A, October 2019)
          • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)
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