The FDA has required its strongest safety warning, i.e., Bolded Warning or Black-Box Warning, be included on a new Uloric drug label to inform about the increased risk of heart-related death and death from all causes with Uloric. From this February 2019 FDA Drug Safety Communication, "FDA adds Boxed Warning for increased risk of death with gout … [Read more...]
J&J Tries to Expand Invokana Label to Include Cardiovascular Benefits
Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs. If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]