June 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 would like to automatically receive our monthly ID Updates by e-mail, subscribe now.
 

June 2018

 

Drug Safety Communications

  • The US FDA has issued a Drug Safety Communication regarding the possible increased risk of neural tube defects among infants born to women who became pregnant while on a dolutegravir-based regimen, based on preliminary results from an ongoing observational study in Botswana. There is no evidence from this study of neural tube defects occurring among infants born to women who initiated a dolutegravir-based regimen after becoming pregnant. Dolutegravir is available as a single agent (brand name Tivicay*) and is also part of the combination products Juluca* and Triumeq*. The full Drug Safety Communication can be found here. The most current recommendations from the HHS Antiretroviral Guidelines Panels, with clinical scenarios and alternatives to treatment with dolutegravir, can be found here. An interim statement from CDC can be found here.

CDC Health Alert Network #411

  • HAN #411 provides current CDC recommendations on the management and reporting of Shigella* infections that have been treated with ciprofloxacin or azithromycin and resulted in possible clinical treatment failure. This is a follow-up to HAN #401 (April 2017) which described an increase in the percentage of Shigella isolates in the US with ciprofloxacin MICs of 0.12–1 μg/mL (classified as susceptible by CLSI criteria). This percentage continues to rise. Molecular data indicate that Shigella isolates in this ciprofloxacin MIC range harbor at least one quinolone resistance mechanism. CDC has also identified an increasing number of Shigella isolates with azithromycin MICs that exceed the epidemiological cutoff value (ECV), and requests reports of any possible azithromycin treatment failures.

New or Updated Treatment Guidelines

Antiretroviral Labeling Changes

  • The approved labeling for darunavir/cobicistat (Prezcobix*) now specifically states that this combination product is not recommended for use in pregnant women due to substantially lower exposures of darunavir and cobicistat. Treatment should not be initiated in pregnant women, and an alternative regimen should be used in women who become pregnant during Prezcobix therapy. 
  • The US FDA has approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada*), in combination with safe sex practices, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents weighing at least 35 kg. Truvada was approved for PrEP in adults in 2012.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • [New on the list]: Cefazolin, Nitrofurantoin oral suspension (unavailable), Recombinant zoster vaccine (Shingrix)
    • [Shortage recently resolved]: Doxycycline injection, Oseltamivir oral suspension, Penicillin G benzathine/Penicillin G procaine 1.2 million units (Bicillin C-R)
    • [Continue to be in reduced supply]:
      • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
      • Cephalosporins: Cefepime, Cefotaxime injection (unavailable), Cefoxitin, Cefpodoxime oral suspension, Ceftazidime, Ceftriaxone, Cefuroxime injection (unavailable)
      • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin oral suspension, Moxifloxacin injection (unavailable)
      • Penicillins: Amoxicillin/clavulanate 1000 mg/62.5 mg ER tablets, Ampicillin/sulbactam, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
      • Other antibacterials: Azithromycin injection, Clindamycin injection, Dalbavancin injection, Erythromycin lactobionate injection (unavailable), Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Vancomycin injection
      • Antifungal drugs: Fluconazole injection
      • Antiparasitic drugs: None
      • Antiviral drugs: None
      • Vaccines: Hepatitis A Virus Vaccine Inactivated (Vaqta), Hepatitis B vaccine recombinant, 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)