January ID Update

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.

January 2019

Drug Safety Communications

  • Following a review of reported cases and four published observational studies, the US FDA has issued a warning that fluoroquinolone antibiotics* can increase the occurrence of aortic aneurysm or dissection. This is the latest in a series of Drug Safety Communications regarding fluoroquinolones dating back to 2008. The drugs should not be prescribed to patients who have an aortic aneurysm or are at risk for one unless no other options are available. The underlying mechanism for the increased risk of an aortic aneurysm event cannot be determined from these studies, and the background risk varies among populations; nevertheless, the data suggest about a two-fold increase in risk in patients taking a fluoroquinolone antibiotic. A warning about this risk will be added to the prescribing information and patient medication guide for all fluoroquinolones. The full communications can be found here.

New Vaccine Approval

  • Vaxelis, a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to H. influenzae type b. It is approved as a 3-dose series in children 6 weeks through 4 years of age (0.5 mL IM at 2, 4, and 6 months of age). The 3-dose series constitutes a primary immunization course against diphtheria, tetanus, polio, and invasive Hib. This combination vaccine may be used to complete the hepatitis B immunization series, and an additional dose of pertussis-containing vaccine is required to complete the primary immunization series against pertussis. Vaxelis is not expected to be commercially available in the US prior to 2020.

New or Updated Treatment Guidelines

  • The latest revisions to the Italian guidelines for the use of antiretroviral agents in HIV-infected patients from the Italian Society for Infectious and Tropical Diseases (New Microbiol 41:247, 2018). This publication updates the 2017 guidelines and are available on the journal website.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 7, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Valganciclovir oral powder for solution
    • [Shortage recently resolved]: Dalbavancin injection
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
      • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
      • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
      • Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection, Piperacillin/tazobactam injection
      • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
      • Antifungal drugs: Fluconazole injection, Nystatin oral suspension (unavailable)
      • Antiparasitic drugs: None
      • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
      • Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).
  • Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
    • Recent discontinuations: Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015)