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Fenspiride (Pneumorel°): serious adverse effects reported over two decades

Despite serious adverse effects reported for more than 20 years, fenspiride (Pneumorel°) was only withdrawn from the market in 2019.

At the beginning of 2019, after noting cases of cardiac rhythm disorders, the French Health Products Agency (ANSM) suspended the marketing authorisation for fenspiride-based medicinal products used in coughing and sputum. This suspension has been extended to the rest of Europe.

Fenspiride had been on the market in France since the 1970s. In 2007, the French National Authority for Health (HAS) considered its medical service to be "insufficient" and products based on fenspiride were downgraded to non-refundable at the beginning of 2008. Fenspiride had been in widespread use: in 2006, the French health insurance scheme reimbursed some 7 million boxes.

In response to a request from Prescrire, ANSM provided a list of reports of adverse reactions to fenspiride from the French pharmacovigilance database. This list includes 525 reports, dated from 1986 to mid-2018. There have been reports of cardiac rhythm disorders since the 1990s-2000s, as well as severe neuropsychological disorders and severe hypersensitivity reactions, including anaphylactic shock and toxidermias.

With uncertain symptomatic efficacy, the harm-benefit balance of fenspiride is unfavourable, which justifies the withdrawal of this drug from the European market in early 2019. The history of fenspiride shows once again the sluggishness of the pharmaceutical companies and agencies in acting to protect patients.

©Prescrire 1 November 2019

"Fenspiride: serious adverse effects that took a very long time to be taken into account" Prescrire Int 2019; 28 (208): 265-267. (Pdf, subscribers only).

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