The nonsteroidal anti-inflammatory drug nimesulide has no proven advantages over first-choice NSAIDs such as ibuprofen; nor does it cause fewer adverse effects, particularly digestive. But for several years nimesulide has been known to cause sometimes fatal hepatic disorders.

Several countries have withdrawn this drug from the market, including Argentina, Belgium, Spain, Finland, Ireland, and Singapore. Furthermore, the European committee responsible for marketing authorisations (Committee for Medicinal Products for Human Use) of the European Medicines Agency (EMA) has clearly established that nimesulide increases the risk of severe hepatic disorders.

Nonetheless, in 2010, the European Commission is still allowing nimesulide to remain on the market, pending further studies. The Commission is proposing simply to modify the information on this drug, whose ineffectiveness and lack of benefits are established, restricting for example the duration of treatment to 2 weeks -- whereas nimesulide is used for the relief of often chronic pain associated with osteoarthritis.

More than a decade after the first suspected cases of hepatic disorders with nimesulide, the authorities are still gathering evidence, including asking pharmaceutical companies to make inquiries in liver transplant centres, where victims of nimesulide are to be found.

Why is the European Commission delaying in withdrawing this drug from the market, to the detriment of patients, if not to benefit pharmaceutical companies?

©Prescrire October 2010