There is a new Xeljanz drug safety warning about an increased risk of blood clots resulting in pulmonary embolism (PE) and deep vein thrombosis (DVT). From this PDF document, “Xeljanz to be used with caution for all patients at high risk of blood clots”, issued in October 2019 by the European Medicines Agency (EMA), we get these details: A review … [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...]
Farxiga / Jardiance / Invokana: Label Change Adds Ketoacidosis Warning
In August 2016 the FDA sent letters to Janssen Pharmaceuticals and AstraZeneca Pharmaceuticals for label changes about fatal cases of ketoacidosis cases involving Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), and Xigduo XR (dapagliflozin and metformin extended-release). As for the other diabetes … [Read more...]