Rare Blood Disorder Indication for Ultomiris Expanded to Include Pediatric Patients
June 7, 2021Prevnar 20 Approved to Prevent Pneumococcal Disease
June 8, 2021Black Box Warning Added to Anthrax Medication
June 7, 2021 – The U.S. FDA has updated the prescribing information for raxibacumab, manufactured by Emergent BioSolutions, to include a black box warning for risk of hypersensitivity and anaphylaxis.
Raxibacumab is a medication indicated for use in combination with appropriate antibacterial drugs to treat inhalational anthrax caused by Bacillus anthracis, and for prophylaxis (prevention) of inhalational anthrax when alternative therapies are not available or are not appropriate. It first received FDA approval in 2012.
Anthrax is a potentially fatal bacterial disease that spreads to humans when they inhale the spores of Bacillus anthracis bacteria, consume food or water contaminated with the spores, or are exposed to the spores through breaks in the skin such as a cut or scrape. It is rare in the United States, as robust veterinary care for livestock – who are exposed to Bacillus anthracis naturally present in soil – helps to reduce the chances of anthrax transmission to humans.