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 … [Read more...]
Xeljanz Safety Concerns and New Precautions
You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death. In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing … [Read more...]
Serious Side Effects For Xeljanz 10 mg Dose Leads To European Drug Safety Regulatory Action
In May 2019 there was more drug safety regulatory action, this time from Europe, regarding the serious side effects associated with Xeljanz related blood clots. We get some details from this news report, “EMA Puts Temporary Restrictions on Tofacitinib Due to PE Risk”: The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment … [Read more...]
Birth Control Pills Series: Are the Current FDA Label Warnings Enough?
In the previous article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I discussed the devastating side effects that can result from using these DRSP-containing birth control pills. For my final article in this series, I will discuss the current drug label warnings for these drugs, and contemplate whether these warnings … [Read more...]
Birth Control Pills Series: The Devastating Side Effects
The first article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz discussed how Yaz in particular was marketed to treat premenstrual dysphoric disorder (PMDD)--before PMDD was even classified as a medical condition--so that the drug manufacturer, Bayer, could increase their profits. In this article, I will provide … [Read more...]