Safety Alerts for Human Medical Products >

U.S. Food and Drug Administration (FDA) Advisories

• September 7, 2011: Tumor Necrosis Factor-alpha (TNFα) Blockers): FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.
• September 1, 2011: Saphris (asenapine maleate): FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections have been revised.
• September 1, 2011: Reclast (zoledronic acid): FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA.

Safety Alerts for Human Medical Products > Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria: - Enviado mediante la barra Google