Another COX-2 inhibitor has been shot down by the FDA. Having spent the last two months reviewing the safety of the COX-2-selective non-steroidal anti-inflammatory drugs (NSAIDs), the US regulatory agency has decided that the risks of life-threatening side-effects associated with Pfizer’s Bextra outweigh its benefits.
As a result, the pharmaceutical giant has been ‘requested’ to voluntarily suspend all sales and marketing of the drug. According to the FDA, its decision was swayed by the lack of adequate data confirming cardiovascular safety with long-term use of Bextra, along with the increased risk of adverse cardiovascular events, reports of serious and potentially life-threatening skin reactions – including deaths – and the lack of any demonstrated advantages with Bextra compared with other NSAIDs.
In addition, manufacturers of all marketed prescription NSAIDs, including the other COX-2 drug, Celebrex, will have to revise the labelling for their products to include a warning to healthcare professionals and consumers of the increased risk of cardiovascular events and of potentially fatal gastrointestinal bleeding associated with these drugs. Even over-the-counter NSAIDs, such as ibuprofen, have been sent to the doghouse, with manufacturers being asked to include more specific information as to the potential risks.
The only drug let off the hook is aspirin because “it has clearly been shown to reduce the risk of serious adverse cardiovascular events in certain patient populations”, says the FDA.