EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
Now that the European Medicines Agency has finalized its formal safety review procedure into Xeljanz, Pfizer is telling health care professionals what precautions they must take when prescribing the drug.
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The European Medicines Agency has been asked to make a recommendation by 30 September on whether the marketing authorization for the products concerned should be maintained, varied, suspended or revoked.
The European Medicines Agency's drug safety committee has concluded that Pfizer's Xeljanz could increase the risk of blood clots in patients who are already at high risk. The committee has also recommended restrictions on the use of Sanofi's multiple sclerosis drug, Lemtrada.
The European Medicines Agency's pharmacovigilance committee has launched a fresh review of Xeljanz and has also recommended suspending all fenspiride medicines, which are used to treat non-serious cough but are associated with heart rhythm problems.