Hemlibra (emicizumab) is used to prevent or reduce the frequency of bleeding episodes in hemophilia A patients. Hemlibra was initially approved by the FDA in 2017. In November 2019, however, some drug safety issues involving Hemlibra were pointed out. From this letter-to-the-editor piece, “Deaths Associated with Emicizumab in Patients with … [Read more...]
Xeljanz FDA Drug Safety Communication About Increased Risks of Blood Clots And Death
This Xeljanz FDA Drug Safety Communication was issued July 26, 2019: “FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)”. From that document we get the following information: The U.S. Food and Drug Administration has approved new … [Read more...]
February 2019: Uloric “Black-Box Warning” For Heart-Related Deaths, Cardiovascular Side Effects
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...]
November 2017 FDA Alert: Uloric May Increase Heart-Related Deaths Risk
On November 15, 2017 there was an email sent by the FDA about this MedWatch Safety Alert, “Febuxostat (Brand Name Uloric): Drug Safety Communication – FDA to Evaluate Increased Risk of Heart-related Death”, from which we get this excerpt: ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk … [Read more...]