Blood Clot Concerns Prompt EU Restrictions For Pfizer's Xeljanz
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.
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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.
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.
Companies developing new AML treatments are among those being called before the European Medicines Agency this week for questioning over marketing applications approaching the end of the review process.