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DECEMBER 2024

Article of the Month (Editors' Choice)

• Pre-exposure prophylaxis (PreP) is an effective strategy to prevent HIV infection. Current US CDC guidelines recommend PreP for HIV-negative sexually active adults and adolescents and persons who inject drugs at substantial risk of acquiring HIV infection. Approved regimens are oral emtricitabine/tenofovir disoproxil fumarate (F/TDF) or oral emtricitabine/tenofovir alafenamide (F/TAF) administered once daily or cabotegravir administered intramuscularly every eight weeks. Efficacy of these regimens is high, approximately 75-90% effective in preventing HIV infection. Lack of adherence to the prescribed regimen is a major reason for failure in preventing HIV infection. A phase 3, multicenter, randomized double-blind controlled trial (PURPOSE 1; N Engl J Med 2024; 391:1179) comparing lenacapavir administered subcutaneously twice-yearly to F/TDF or F/TAF, administered orally once daily, for prevention of HIV infection in cis-gender women in South Africa and Uganda found 0 infections among 2134 participants in the lenacapavir group, 39 infections among 2136 participants in the F/TAF group, and 16 infections among 1068 participants in the F/TDF group. The rates of HIV infection with lenacapavir were significantly lower from background rates of new HIV infection, whereas rates for F/TAF and F/TDF were not. Lack of efficacy with F/TAF and F/FDF was largely attributable to poor adherence to these once daily oral regimens. Twice-yearly subcutaneous lenacapavir is a highly efficacious option for PreP for prevention of HIV infection in women, and probably in other high-risk groups as well.

  A second phase 3, multicenter, randomized trial (PURPOSE 2; New Engl J Med on line 27 Nov 2024 https://www.nejm.org/doi/full/10.1056/NEJMoa2411858) evaluated cisgender men, transgender women, transgender men, and gender-nonbinary persons, randomized 2:1 to receive lenacapavir every 26 weeks or F/TDF. Among 3,265 participants HIV infection occurred in 2 / 2183 individuals assigned to lenacapavir (0.1 per 100 person-years) and 9 / 1088 individuals assigned to F/TDF (0.93 per 100-person years). The incidence of HIV in the lenacapavir group was significantly lower than the F/TDF group (incidence rate ratio 0.11, 95% CI 0.02 – 0.51; p < 0.002). A total of 26 participants (1.2%) discontinued lenacapavir owing to injection site reactions (vs 0.3% in the F/TDF group). No other safety concerns were identified.

  Taken together, twice yearly SQ lenacapavir is a highly efficacious PrEP regimen that performed better than daily oral therapy in 2 large RCTs. It is currently under review by the US Food and Drug administration for approval.

• Authors: Henry F. Chambers, MD and Michael S. Saag, MD
• An earlier version of this section misnamed the clinical trials as PROMISE. The correct name is PURPOSE.

CDC Routine Immunization Schedules (2025)

• The official recommendations were published online on November 21. Updated links are now live on our page Master Immunization Schedules (CDC & WHO).
• All Sanford Guide vaccine pages were updated in conjunction with 2024 ACIP meetings as they occurred. The following points of clarification were, however, added by CDC with the publication of the 2025 recommendations:
  • Heplisav-B is now recommended as acceptable during pregnancy. 
  • HIV infection of any severity is a contraindication for use of ProQuad (MMRV; Merck). The criteria for MMR or varicella alone have not changed.
  • Additional doses of RSV vaccine are not recommended in subsequent pregnancies.
  • Fluzone HD and Fluad influenza vaccine are an option in persons aged 18 through 64 years who are solid organ transplant recipients receiving immunosuppressive medications. 

Mpox - LC16m8 Vaccine

• LC16-Kaketsuken (LC16m8; KM Biologics, Japan) is a minimally replication-competent vaccinia-virus vaccine approved and available in Japan for both children ≥1 year of age and adults.
  • Limited published human data but similar to other vaccinia based vaccines with robust "takes" in vaccinees.
  • Administered percutaneously using a bifurcated needle.
  • WHO EUL issued in November 2024 for deployment to the African outbreak including children ≥1 year of age.

PreHevbrio Discontinued

• VBI Vaccines, the manufacturer of the PreHevbrio brand of hepatitis B vaccine, declared bankruptcy and is ending business operations. PreHevbrio is no longer being distributed. The recall is not related to vaccine safety or quality.
• Customers with the product are asked to destroy or return remaining doses.
• All properly administered doses of PreHevbrio are valid hepatitis vaccinations and do not need to be repeated.  

New or Updated Practice Guidelines

• ACG Clinical Guideline: Treatment of Helicobacter pylori Infection (Am J Gastroenterol 2024;119:1730-1753).
  • Recommendations for North America.
  • Preferred regimen (treatment-naive, antibiotic susceptibility unknown, with or without penicillin allergy): bismuth quadruple therapy (PPI, bismuth subcitrate or subsalicylate, tetracycline, metronidazole) x14 days.
  • Suitable empiric alternatives (treatment-naive, non-penicillin allergic): rifabutin triple therapy (omeprazole, amoxicillin, rifabutin) or vonoprazan dual therapy (vonoprazan, amoxicillin) x14 days.
• Antiretroviral Drugs for Treatment and Prevention of HIV In Adults: 2024 Recommendations of the International Antiviral Society-USA Panel (JAMA 2024 Dec 1. doi: 10.1001/jama.2024.24543. Online ahead of print).
  • Last updated in 2022. Notable updates are seen in ART recommendations for pregnancy, management of virologic failure, switching in virologically suppressed patients, and use of long-acting agents.
  • Accompanying editorial (good summary): JAMA 2024 Dec 1. doi: 10.1001/jama.2024.24027. Online ahead of print.

Antimicrobial Shortages (US)

• New shortages:
  • Azithromycin oral suspension, 1 gm packets (20 Nov 2024)
    
  • Ibrexafungerp 150 mg tablets (3 Dec 2024)
• Resolved shortages:
  
  • Acyclovir injection (27 Nov 2024)
  
  
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 9 December 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • Metronidazole injection (20 Oct 2021)
    • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
    • Nitrofurantoin oral suspension (5 Jun 2018)
    • Oxazolidinones:
      • Linezolid injection (16 Oct 2024)
    • Penicillins:
      • Amoxicillin, all oral formulations (18 Oct 2022)
      • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
      • Ampicillin injection (19 Oct 2023)
      • Dicloxacillin 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
    • Fluconazole injection (9 Aug 2024)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
  • Antiparasitic drugs:
    • Mefloquine 250 mg tablets (14 May 2024)
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Cidofovir injection (01 Nov 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

NOVEMBER 2024

COVID-19 mRNA Vaccine: Updated Recommendations

• Summary of guidelines for persons ≥5 years of age who are not moderately or severely immunocompromised:

  • Initial vaccination:

    • 1 dose of 2024–25 Moderna or Pfizer vaccine

  • Received previous doses of a COVID-19 vaccine:

    • 1 dose of 2024–­25 Moderna or Pfizer vaccine

  • No additional doses of 2024–­25 vaccine for people <65 years of age who are not moderately or severely immunocompromised are recommended at this time.

  • Persons >65 years or age should receive 2 doses of 2024–2025 mRNA vaccine separated by 6 months (minimum interval 2 months) regardless of previous vaccination history, October 2024 guidelines for people >5 years of age who are not moderately or severely immunocompromised.

• Dosing, including additional discretionary doses for the moderately and severely immunocompromised, remains complex.

Pneumococcal Vaccination: Significant Changes

• For all PCV-naïve adults >50 years of age, a single dose of either PCV20 (Prevnar 20) or PCV21 (Capvaxive), or a series of PCV15 (Vaxneuvance) followed one year later by PPSV23 (Pneumovax 23), is now recommended.
  

  • An estimated 32–54% of adults age 50-64 years already have a risk-based indication for vaccination.

• PCV21 (Capvaxive, Merck) is FDA-approved and now available. 
• Same regimens for persons 19-49 years of age with underlying conditions.
• Standard of care is a conjugated vaccine (PCV21, PCV20, or PCV15)
  • PPSV 23 (Pneumovax 23) alone is no longer recommended under any circumstances.
• The PCV21 alone regimen appears preferable, despite PCV20 or the PCV15/PPSV23 options considered as equivalent by ACIP guidelines.

Mpox Indication for ACAM2000

• ACAM2000 is a live vaccinia virus vaccine previously indicated for the prevention of smallpox disease in individuals determined to be at high risk for infection. In August 2024 the US FDA added prevention of mpox as an indication to the ACAM2000 product labeling based on animal challenge data. Large quantities of ACAM2000 remain in the Strategic National Stockpile, but due to the more favorable tolerability of Jynneos, no doses have been released in recent years.

Sulopenem Etzadroxil-Probenecid Approved

• The US FDA has approved sulopenem etzadroxil-probenecid (Orlynvah) for the treatment of uncomplicated UTI caused by E. coli, K. pneumoniae, or P. mirabilis in adult women with limited or no alternative oral treatment options. Sulopenem etzadroxil is a thiopenem prodrug that is hydrolyzed to sulopenem upon oral administration. Systemic exposure is boosted by probenecid (an OAT1/3 inhibitor), which may increase plasma concentrations of other drugs dependent on OAT1/3 for elimination. In two phase 3 studies, the most common adverse reactions leading to treatment discontinuation were gastrointestinal. One tablet contains 500 mg of sulopenem etzadroxil and 500 mg of probenecid. The approved dose is one tablet q12h x5 days. Administration in patients with CrCl <15 mL/min or on hemodialysis is not recommended.

Antimicrobial Shortages (US)

• New shortages:
  • Cidofovir injection (01 Nov 2024)
  • Linezolid injection (16 Oct 2024)
    
• Resolved shortages:
  
  • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
  
  
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 10 November 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • 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 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
    • Fluconazole injection (9 Aug 2024)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
  • Antiparasitic drugs:
    • Mefloquine 250 mg tablets (14 May 2024)
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Acyclovir injection (21 Feb 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

OCTOBER 2024

Aztreonam-Avibactam approved in Europe

• Aztreonam-avibactam is a new monobactam / β-lactamase inhibitor combination. It was approved by the European Commission on 22 April 2024 for these indications in adults:
  
  • Complicated intraabdominal infection (± metronidazole)
  • HAP/VAP
  • Complicated UTI including pyelonephritis
  • Infections caused by aerobic gram-negative organisms in patients with limited treatment options
• Aztreonam is a monobactam β-lactam that is active against many Enterobacterales, P. aeruginosa, and other gram-negative organisms. It has no useful activity vs anaerobes or gram-positive organisms. It is generally stable to hydrolysis by Ambler class B enzymes (metallo-β-lactamases).
• Avibactam is a non-β-lactam, β-lactamase inhibitor. It inhibits Ambler class A and class C β-lactamases and some class D enzymes, including ESBLs, KPC and OXA-48 carbapenemases, and AmpC. Avibactam does not inhibit class B enzymes, and it is not able to inhibit many class D enzymes.
• The recommended dosage in normal renal function is 2 gm/0.67 gm (aztreonam-avibactam) IV load, then 1.5 gm/0.5 gm IV q6h. Doses are to be infused over three hours. The recommended duration of treatment is 5-14 days depending on the indication.

CDC COVID-19 Vaccine Recommendations, 2024-2025

• US CDC vaccine recommendations for COVID-19 are summarized in the Sanford Guide:
  • mRNA vaccines, age <5 years
  • mRNA vaccines, age ≥5 years
  • Novavax vaccine
• CDC report (MMWR 2024;73:819-824) available in PDF form here.

Emergency Use Instructions for Oseltamivir

• On 19 July 2024, CDC issued Emergency Use Instructions (EUI) for oseltamivir for treatment or post-exposure prophylaxis (PEP) of pandemic influenza A viruses and novel influenza A viruses with pandemic potential. EUI provide information about emergency use of FDA-approved medical products that differ from or go beyond what is in the FDA-approved product labeling. Information on the following is provided in this EUI:
  
  • Initiation of oseltamivir treatment after 48 hours from symptom onset.
  • Treatment of severely ill hospitalized patients, including longer courses of treatment (e.g., 10 days), based on clinical judgment.
  • Higher total daily dose and flexible duration for PEP. The EUI-recommended dosing regimen in most cases is twice daily for 5 or 10 days in asymptomatic close contacts of a confirmed or probable novel influenza A case or asymptomatic persons exposed to animals infected with highly pathogenic avian influenza A(H5N1) virus or other novel influenza A viruses.
  • Treatment of term neonates under 2 weeks of age.
  • PEP in neonates and infants less than 1 year of age.
  • Treatment and PEP dosing regimens for preterm neonates and infants.
• Useful links:
  • EUI for oseltamivir (19 July 2024).
  • Recommendations for treatment of novel influenza A virus infections associated with severe human disease in the US (12 Sept 2024).

Fexinidazole and HAT

• New 2024 WHO Guidelines for human African trypanosomiasis (HAT) establish oral treatment with fexinidazole (available in the US from Sanofi) as first-line against both East African and West African strains, no matter the disease stage. US CDC is in the process of updating their online materials to correspond.

Antimicrobial Shortages (US)

• New shortages:
  • None
    
• Resolved shortages:
  
  • Isoniazid injection 100 mg/mL (15 Aug 2024)
    
  • Valganciclovir powder for oral solution (12 Sep 2024)
  • Valganciclovir 450 mg tablets (12 Sep 2024)
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 6 October 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • 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 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
    • Fluconazole injection (9 Aug 2024)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
  • Antiparasitic drugs:
    • Mefloquine 250 mg tablets (14 May 2024)
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Acyclovir injection (21 Feb 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

SEPTEMBER 2024

From CDC

• Clinical guidance for the newly approved 21-valent pneumococcal conjugate vaccine (PCV21). PCV21 contains eight serotypes not included in other licensed vaccines. On June 27, 2024, ACIP recommended a single dose of PCV21 as an option for adults aged ≥19 years for whom a pneumococcal conjugate vaccine (PCV) is currently recommended. Indications for PCV have not changed from previous recommendations (MMWR 2024;73:793-798). PDF of full report available here.

Global Guideline for Cryptococcosis

• Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM (Lancet Infect Dis 2024;24:e495-512). More than 70 societies internationally have endorsed the content, structure, evidence, recommendation, and pragmatic wisdom of this global cryptococcosis guideline. For induction therapy of cryptococcal meningitis, disseminated cryptococcosis, and severe isolated pulmonary cryptococcosis in high-income settings, the guideline recommends two weeks of liposomal amphotericin B (3–4 mg/kg IV q24h) plus flucytosine 25 mg/kg po q6h. For induction therapy of HIV-associated cryptococcal meningitis in low-income settings, the guideline suggests liposomal amphotericin B 10 mg/kg IV as a single dose with two weeks of flucytosine 25 mg/kg po q6h plus fluconazole 1200 mg q24h (note: this regimen has not been trialed in non-HIV-associated cryptococcal meningitis or other non-CNS cryptococcosis syndromes). PDF of guidelines available here (must register for free access).

Updated SIS Guidelines

• The Surgical Infection Society (SIS) has published its 2024 evidence-based guideline update on the management of intraabdominal infection in adults. Previous versions were published in 1992, 2002, 2010, and 2017 (Surg Infect 2024;25:419-435). PDF of guidelines available here.

Antimicrobial Shortages (US)

• New shortages:
  • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
    
• Resolved shortages:
  
  • Isoniazid injection 100 mg/mL (15 Aug 2024)
    
  • Valganciclovir powder for oral solution (12 Sep 2024)
  • Valganciclovir 450 mg tablets (12 Sep 2024)
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 16 September 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • 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 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
    • Fluconazole injection (9 Aug 2024)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
  • Antiparasitic drugs:
    • Mefloquine 250 mg tablets (14 May 2024)
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Acyclovir injection (21 Feb 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

AUGUST 2024

From IDSA

• 2024 Guideline update on the risk assessment, diagnostic imaging, and microbiological evaluation of complicated intraabdominal infections in adults, children, and pregnant people. This is part 1 of an update to the 2010 SIS/IDSA guidelines. Click here.
• 2024 Guidance update focused on antimicrobial-resistant infections caused by extended-spectrum β-lactamase-producing Enterobacterales, AmpC β-lactamase-producing Enterobacterales, carbapenem-resistant Enterobacterales, Pseudomonas aeruginosa with difficult-to-treat resistance, carbapenem-resistant Acinetobacter baumannii, and Stenotrophomonas maltophilia. This update replaces earlier versions. Click here.

Antimicrobial Shortages (US)

• New shortages:
  • Fluconazole injection (9 Aug 2024)
    
• Shortages recently resolved:
  • Erythromycin 0.5% ophthalmic ointment (26 Jul 2024)
  • Amphotericin B injection (6 July 2024)
    
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 11 August 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • 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 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
    • Nystatin oral suspension (21 June 2024)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
    • Isoniazid injection 100 mg/mL (24 Jan 2024)
  • Antiparasitic drugs:
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Acyclovir injection (21 Feb 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)
    • Valganciclovir powder for oral solution (7 Feb 2023)
    • Valganciclovir 450 mg tablets (7 Feb 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

JULY 2024

COVID-19 Vaccine

• CDC has officially recommended that everyone ≥6 months of age, whether or not they have ever previously been vaccinated with a COVID-19 vaccine, receive an updated 2024-25 vaccine this fall.
• Detailed guidelines will be published as soon as the new vaccines are available. Antigenic composition:
  • KP.2 for Moderna and Pfizer mRNA vaccine.
  • JN.1 for Novavax recombinant protein vaccine (not approved for age <12 years).
• The current 2023-2024 vaccine formulation and guidelines should be followed until then.

RSV Vaccine

• As of June 2024, three RSV vaccines (Arexvy [GSK], Abrysvo [Pfizer], mRESVIA [Moderna]) are FDA-approved, with ACIP guidelines in place.
  • In clinical trials, vaccine effectiveness (VE) of a single dose in the first and second year against severe outpatient disease were, respectively, Abrysvo 86% and 74%, Arexvy 79% and 59%, and mRESVIA 55% and 36%.
  • Real-world observational data for hospitalization from US hospitals during winter 2023-24 showed:
    • For both Arexvy and Abrysvo, VE was approximately 80% against RSV-associated hospitalization, ED visits and critical illness.
    • mRESVIA was unavailable during winter 2023-24.
  • Excess cases of Guillain-Barre Syndrome are seen with Abrysvo and, to a lesser extent, Arexvy, but so far not with mRESVIA.
  • Risk-benefit analysis is vastly in favor of vaccination per these indications:
    • All adults >75 years of age.
    • Adults 60–74 years of age with certain chronic medical conditions or other factors that increase risk of severe RSV disease.
    • NOT recommended for adults 60–74 years of age who are not at increased risk of severe RSV.

Antimicrobial Shortages (US)

• New shortages:
  • Nystatin oral suspension (21 June 2024)
    
• Shortages recently resolved:
  • Amphotericin B injection (6 July 2024)
    
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 7 July 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 

  • Antibacterial drugs:
    • Aminoglycosides:
      
      • Gentamicin injection (22 Feb 2021)
    • Cephalosporins:
      • Cefazolin injection (4 Jun 2018)
      • Cefdinir 300 mg capsules (29 Jun 2023)
      • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
      • Cefotaxime injection (10 Jun 2015)
        
        • 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)
      • Levofloxacin injection in D5W (29 May 2024)
      • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
      • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Ofloxacin 0.3% ophthalmic solution (22 Dec 2022)
    • Glycopeptides, glycolipopeptides, lipopeptides:
      
      • Vancomycin injection (1 Jun 2015)
    • Macrolides/azalides:
      
      • 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 250 mg, 500 mg capsules (18 Aug 2021)
      • Nafcillin injection (20 Mar 2024)
      • Penicillin G benzathine injection (1 Feb 2023) Availability update here
      • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update here
      • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
      • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
    • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
    • Rifaximin 200 mg tablets (11 Apr 2024)
  • Antifungal drugs: 
    
    • Amphotericin B Lipid Complex (5 Aug 2022)
  • Antimycobacterial drugs: 
    
    • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
    • Isoniazid injection 100 mg/mL (24 Jan 2024)
  • Antiparasitic drugs:
    • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
  • Antiviral drugs: 
    
    • Acyclovir injection (21 Feb 2024)
    • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
    • Oseltamivir powder for oral suspension (1 Nov 2022)
    • Ribavirin for inhalation solution (23 May 2023)
    • Valganciclovir powder for oral solution (7 Feb 2023)
    • Valganciclovir 450 mg tablets (7 Feb 2023)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

JUNE 2024

Doxy-PEP Guidelines

• CDC guidelines on the use of doxycycline postexposure prophylaxis for prevention of chlamydia, gonorrhea, and syphilis (MMWR Recomm Rep 2024;73:1-8). PDF available here.

RSV Vaccine safety

• Early V-safe and VAERS data during first season of use (MMWR 2024;73:489)
  • Guillain-Barre syndrome (GBS) rates of 5.0 and 1.5 reports per million doses of Abrysvo and Arexvy vaccines, respectively, among US adults ≥60 years of age, which were higher than background rates.
  • A small and inconclusive safety signal related to inflammatory neurologic conditions (acute disseminated encephalomyelitis or GBS) has been reported in trials with both vaccines.

Drug Shortages (US)

• Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
• New shortages:
  • Levofloxacin injection in D5W (29 May 2024)
    
• Shortages recently resolved:
  • Nystatin topical powder (22 May 2024)
    
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 10 June 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 (22 Dec 2022)
    • 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)
      • Nafcillin injection (20 Mar 2024)
      • 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)
    • Rifaximin 200 mg tablets (11 Apr 2024)
    • 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)
  • 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
      

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

MAY 2024

Pivmecillinam Approved

• Pivmecillinam (Pivya) has been approved by the US FDA for female patients ≥18 years of age with uncomplicated UTI caused by susceptible isolates of E. coli, P. mirabilis and S. saprophyticus. It is a pivalate ester prodrug that is well absorbed and rapidly hydrolyzed to mecillinam (the active agent) by nonspecific esterases present in the blood, GI mucosa, and elsewhere. Unlike most other beta-lactams, mecillinam preferentially targets PBP-2 in the bacterial cell wall. The US recommended dose is 185 mg q8h x3-7 days, with or without food. Pivmecillinam 185 mg is equivalent to pivmecillinam hydrochloride 200 mg.

WHO Guidelines for Qdenga Published

• US travelers may ask about use of Qdenga dengue vaccine (TAK-003; Takeda) which has not yet been submitted to the FDA but which is available commercially in Europe (including at some hub airports) and some other countries.  No other dengue vaccine is currently available anywhere.
  • WHO SAGE Wkly Epidemiol Rec. 2024 May 3;99:203
    • Consider for introduction in natives of high burden, high transmission settings.
      • For 6-16 yrs of age at 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations.
    • Recommendations for travelers:
      • Highest benefit is during an ongoing DENV2 or DENV1 epidemic at the destination.
      • Previously infected (any serotype) seropositive travelers MAY benefit from Qdenga vaccination.
        • Pre-vaccination serostatus screening is not required, but may be considered to inform the assessment of risks and benefits.
      • The benefits of vaccination are lower for seronegative travelers
        • Any protection of seronegative persons against DENV3 and DENV4 is uncertain and the circulating serotypes at any destination may vary over time. 
      • Protection starts 14 days after the first dose.

From CDC: Replenishing Tecovirimat (Tpoxx) Supply

• The large-scale prepositioning of oral tecovirimat (Tpoxx) was discontinued on February 27, 2023, with the significant decline in mpox case that has continued to remain low. For contingency planning considerations, the ASPR/HHS has been accepting one-time, prepositioning requests for up to 20 bottles of oral tecovirimat for jurisdictions where the previously pre-positioned supply has been exhausted or has expired. The one-time, contingency supply request can be made directly to ASPR through HPOP. ASPR will follow up to review each request. For more information, please see TPOXX Operational Planning Guide. Stockpiled tecovirimat use for treatment of mpox must be in accordance with the CDC-held Tecovirimat Expanded Access Investigational New Drug (EA-IND) protocol.
• Tecovirimat is not FDA-approved for treatment of human mpox. Oral tecovirimat is only available through the Study of Tecovirimat for Human Mpox Virus (STOMP), a clinical trial sponsored by NIH to evaluate efficacy of tecovirimat in treating human mpox, or for compassionate use under the CDC-held Tecovirimat Expanded Access Investigational New Drug (EA-IND) protocol. STOMP has a randomized arm and open-label tecovirimat arm. Non-pregnant adults with mild mpox are enrolled in the randomized arm at 2:1 ratio of tecovirimat to placebo. At any time during the study, if those enrolled in the randomized arm develop severe disease or persistent pain, they are crossed over to the open-label tecovirimat arm. Those with severe disease or severe immunocompromise, pregnant or lactating persons, and children are enrolled in the open-label tecovirimat arm.
• Tecovirimat for treatment of mpox under CDC’s tecovirimat expanded access IND protocol is for patients who meet EA-IND eligibility (e.g., those with severe disease or severe immunocompromise OR pregnant or lactating persons and children irrespective of disease severity or immune status). Stockpiled oral or IV tecovirimat remains available for presenting mpox patients who meet EA-IND eligibility and can be requested by calling the CDC Emergency Operations Center (EOC) at (770) 488-7100. Any jurisdiction with remaining, unexpired supply can provide tecovirimat for patients who meet EA-IND eligibility. Providers may also want to contact their state or local health department to see if any local pre-positioned supply remains.

Drug Shortages (US)

• Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
• New shortages:
  • None
• Shortages recently resolved:
  • Doxycycline oral suspension (22 Mar 2024)
• Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 12 May 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 (22 Dec 2022)
    • 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)
      • Nafcillin injection (20 Mar 2024)
      • 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)
    • Rifaximin 200 mg tablets (11 Apr 2024)
    • 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
      

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

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)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

MARCH 2024

SARS-CoV-2 / COVID-19

• Sanford Guide SARS-CoV-2 / COVID-19 main page.
• COVID-19 vaccination in cancer patients: recommendations from NCCN here.
• Currently authorized vaccines. See COVID-19 vaccines (Age ≥12 yrs) and COVID-19 vaccines (Age <12 yrs) for use and data.
• ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
• Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention:
  • IDSA (last updated 6/26/23)
  • NIH (last updated 12/20/23)
• Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
• Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
• Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
• Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

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)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

FEBRUARY 2024

SARS-CoV-2 / COVID-19

• Sanford Guide SARS-CoV-2 / COVID-19 main page.
• COVID-19 vaccination in cancer patients: recommendations from NCCN here.
• Currently authorized vaccines. See COVID-19 vaccines (Age ≥12 yrs) and COVID-19 vaccines (Age <12 yrs) for use and data.
• ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
• Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention:
  • IDSA (last updated 6/26/23)
  • NIH (last updated 12/20/23)
• Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
• Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
• Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
• Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

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)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/

JANUARY 2024

SARS-CoV-2 / COVID-19

• Sanford Guide SARS-CoV-2 / COVID-19 main page.
• COVID-19 vaccination in cancer patients: recommendations from NCCN here.
• Currently authorized vaccines. See COVID-19 vaccines (Age ≥12 yrs) and COVID-19 vaccines (Age <12 yrs) for use and data.
• ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
• Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention:
  • IDSA (last updated 6/26/23)
  • NIH (last updated 12/20/23)
• Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
• Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
• Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
• Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

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)

• For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/