Alerts & Corrections

AHFS Drug Information/Essentials Update – November 2016

The November update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New AHFS/Essentials Monographs

  • Alectinib (Alecensa®)
  • Atezolizumab (Tecentriq®)
  • Daratumumab (Darzalex®)
  • Elotuzumab (Empliciti®)
  • Ixazomib (Ninlaro®)
  • Necitumumab (Portrazza®)
  • Osimertinib (Tagrisso®)
  • Palbociclib (Ibrance®)
  • Sonidegib (Odomzo®)
  • Trabectedin (Yondelis®)
  • Trifluridine and Tipiracil (Lonsurf®)
  • Venetoclax (Venclexta®)

FDA MedWatch Alerts

  • FDA is warning about the risk of hepatitis B virus (HBV) reactivation in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral medicines for hepatitis C virus.
    • Affected monographs:
      • Simeprevir
      • Sofosbuvir
      • Ledipasvir and Sofosbuvir
      • Ombitasvir, Paritaprevir, and Ritonavir with Dasabuvir Sodium
      • Daclatasvir
      • Ombitasvir/Paritaprevir/Ritonavir
      • Elbasvir and Grazoprevir
  • FDA added a new warning and updating the Abuse and Dependence section to include new safety information regarding the risks associated with abuse and dependence of testosterone and other anabolic steroids.
    • Affected monographs:
      • Oxandrolone
      • Danazol
      • Testosterone
      • Methyltestosterone
      • Fluoxymesterone