Serious Side Effects For Xeljanz 10 mg Dose Found In Pfizer Post-Marketing Study Leads To New European Drug Safety Regulatory Action
The serious side effects associated with Xeljanz related blood clots first came to our attention in February 2019, at which time we wrote this earlier article, "Xeljanz Recommended Dosage For Ulcerative Colitis Patients May Increase Risk Of Pulmonary Embolism".
Less than a week later this February 25, 2019 FDA Drug Safety Communication was issued "Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate".
Then last month, in May 2019, there was more drug safety regulatory action, this time from Europe, as reported in 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".
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A good summary of the practical effect of the action taken in Europe is presented by this news report, "EU regulators slap safety restriction on Pfizer’s Xeljanz":
European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.
Xeljanz (tofacitinib) is approved at the higher dose of 10 mg twice daily in patients with ulcerative colitis, although this can be reduced to 5 mg twice daily in patients who respond well.
The decision means that as the 10 mg twice daily is the starting dose for all patients, no new patients should be started on the drug in ulcerative colitis....
Xeljanz is not approved in rheumatoid arthritis in Europe at the higher dose, but is available in that dose in the US, and Pfizer’s data came from a cardiovascular post-marketing safety study required by the FDA as a condition of its licence.
We point out that Xeljanz is also approved as a treatment for psoriatic arthritis that calls for a twice daily Xeljanz 5 mg dose, which is not affected by the present drug safety concerns for Xeljanz.
We will continue to monitor developments with respect to the drug safety profile of Xeljanz in the US and Europe.
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