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Parecoxib and fatal skin reactions: when will this drug be withdrawn from the European market?

The risk-benefit balance of cox-2 inhibitor anti-inflammatories is unfavourable. The European Medicines Agency has merely indicated the risk of a potentially fatal skin reaction with parecoxib, instead of demanding its withdrawal from the market.

The decision of the European Medicines Agency (EMA) to simply alter the patient information leaflet for parecoxib (a cox-2 inhibitor nonsteroidal anti-inflammatory drug) rather than to demand the drug’s withdrawal from the market is unacceptable.

In 2009, following three deaths linked to severe skin reactions associated with parecoxib, the EMA added a warning of this risk to the information for this drug.

The body metabolises parecoxib into valdecoxib, a substance present in the drug Bextra°. This drug was withdrawn from the market in Europe and in the USA in 2005, due to its unfavourable risk-benefit balance associated with severe adverse cardiovascular and skin effects.

Because of the close link between the two substances, parecoxib was withdrawn from the Swiss market in 2005 and the US medicines agency refused it a marketing authorisation.

Why are the European authorities so slow to withdraw parecoxib and the other cox-2 inhibitors from the market?

©Prescrire 1 October 2010

"Parecoxib and fatal skin reactions" Prescrire Int 2010; 19 (109): 203. (Pdf, subscribers only).
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