Every 3 months, FDA updates its New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System listings (here) to include newly identified potential serious risks that FDA is investigating. The FDA wants to emphasize that “[T]he appearance of a drug or biological product on a quarterly report does […]
The FDA warns about the potential for rare but severe itching after discontinuation of cetirizine or levocetirizine for both over-the-counter (OTC) and prescription drug products (here). The FDA says, ”[t]he itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. […]
The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan). The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]
