THE European Medicines Association (EMA) safety committee has recommended the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
This follows a review that has confirmed these cough medicines could cause heart rhythm problems.
The European regulatory agency has also tightened its recommendations around the use of Xeljans (tofacitinib), saying doctors must not prescribe the 10mg twice daily dose in patients who are at high risk of blood clots in the lungs.
This restriction was first floated in Mar following early indications there could be an association of increased risk for rheumatoid arthritis patients (PD 22 Mar 19).
Doctors are also warned to be alert to other factors such as age, obesity, smoking or immobilisation.
Ulcerative colitis patients should have their Xeljans therapy ceased, the EMA has said.
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