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 Committee (PRAC) is temporarily advising physicians not to prescribe the 10-mg twice-daily dose of tofacitinib (Xeljanz, Pfizer) to patients at high risk for pulmonary embolism (PE).
These include patients with heart failure, cancer, inherited coagulation disorders, a history of venous thromboembolism, either deep venous thrombosis (DVT) or PE, as well as patients taking combined hormonal contraceptives or hormone replacement therapy or who are scheduled to have major surgery.
Prescribers should also consider other factors that may increase the risk for PE, including age, obesity, smoking, or immobilization, the EMA said in a news release.
In addition, there is this Drug Safety Update article issued by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), “Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing”.
We will continue to monitor developments with respect to the drug safety profile of Xeljanz in the US and Europe.
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