EMA’s PRAC to review Xeljanz and recommends fenspiride withdrawl

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fenspiride medicines.

The Xeljanz restriction comes as the organisation has started a new review of the drug, and has recommended, as a temporary measure during the review, that doctors must not prescribe the 10 mg twice-daily dose of this medicine in patients who are at high risk of blood clots in the lungs.

The Pfizer oral JAK inhibitor is currently authorised for the treatment of rheumatoid arthritis, psoriatic arthritis and severe ulcerative colitis.

The PRAC stated that these include patients who have heart failure, cancer, inherited blood clotting disorders or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement therapy or are undergoing major surgery.

The recommendation follows results from an ongoing study in patients with rheumatoid arthritis, which showed an increased risk of blood clots in the lungs and death when the 10 mg twice daily dose was used.

The Committee also recommended withdrawal of marketing authorisations for cough medicines containing fenspiride, following a review that has confirmed that fenspiride medicines could cause heart rhythm problems.

In the release, the PRAC also noted that healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking them. Patients are advised to stop taking these medicines and contact their doctor or pharmacist for advice on alternative treatments, if needed.

Currently fenspiride medicines are available as syrup or tablets and used in adults and children from the age of two years to relieve cough resulting from lung diseases.

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