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Pharmacovigilance

EMA committee says cough medicines containing fenspiride should not be marketed

A European Medicines Agency (EMA) committee has recommended that marketing authorisations for cough medicines containing fenspiride should be revoked, meaning they will no longer be marketed in the EU.

The Pharmacovigilance Risk Assessment Committee (PRAC), which met between 13–16 May 2019, came to its conclusion following a review of evidence confirmed that fenspiride-containing medicines could cause heart rhythm problems.

The committee said that — because heart rhythm problems can be serious and occur suddenly and fenspiride medicines are used to treat non-serious cough — the benefit–risk balance means that these medicines should no longer be marketed.

The PRAC has advised healthcare professionals against prescribing fenspiride medicines and said that they should also advise their patients to stop taking them. Patients are advised to contact their doctor or pharmacist for advice on alternative treatments, if needed.

The recommendation will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures — Human to make a decision about its implementation.

Also at its May 2019 meeting, the PRAC discussed the start of a new review into tofacitinib (Xeljanz; Pfizer UK), after the results from an ongoing rheumatoid arthritis (RA) study found that the medicine increased the risk of blood clots in the lungs, and death, when the 10mg twice daily dose was used.

Tofacitinib is indicated for moderate-to-severe active RA in patients who have had an inadequate response to, or are intolerant to one or more disease-modifying anti-rheumatic medicines, as well as psoriatic arthritis and severe ulcerative colitis.

While it completes the review, the PRAC has recommended that, as a temporary measure, doctors must not prescribe the 10mg twice-daily dose of this medicine, which is the recommended starting dose for ulcerative colitis, in patients who are at high risk of blood clots in the lungs.

The new recommendations are temporary and follow previous PRAC advice not to exceed the recommended 5mg twice daily dose when treating rheumatoid arthritis.

  • This article was corrected on 24 May 2019 to highlight that tofacitinib is indicated for psoriatic arthritis and severe ulcerative colitis in addition to rheumatoid arthritis (RA), and that the 10mg twice-daily dose is currently only recommended for ulcerative colitis. The recommended twice daily dose for RA is 5mg.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206575

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