The controversial anti-inflammatory painkiller, Bextra, has been removed from sale in the US because of heart risks, it was announced on Thursday.
In a U-turn that will please many patients鈥� groups, the US Food and Drug Administration (FDA) asked Pfizer, which makes Bextra (valdecoxib), to remove it from sale. Yet as recently as February 2005, the FDA concluded that Bextra鈥檚 benefits outweighed its risks and refused to call for the drug鈥檚 removal, against the advice of a panel of doctors and scientists.
The late removal is expected to provoke a wave of litigation across the US by campaigners who claim the drug has caused heart attacks or strokes in people taking it.
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Bextra is the second in the class of non-steroidal anti-inflammatory (NSAID) medicines, known as Cox-2 inhibitors, to be removed from sale due to heart risks. In September 2004, the Cox-2 drug Vioxx (rofecoxib) was voluntarily removed from sale by its manufacturer, Merck, following a series of studies showing that the drug might double the risk of heart attack and stroke among long-term users.
Studies since then have shown that the two other drugs in the same class 鈥� Bextra and Celebrex (celecoxib), both manufactured by Pfizer 鈥� can markedly increase the risk of heart attacks and strokes, and medical experts have campaigned for both drugs to be removed from sale. As well as asking Pfizer to remove Bextra from sale in the US, the FDA has asked it to add additional warning labels to Celebrex, highlighting the increased cardiovascular risks.
Risk versus benefit
The FDA has concluded that 鈥渢he overall risk versus benefit profile of Bextra is unfavourable鈥�, whereas 鈥渢he benefits of Celebrex outweigh the potential risks in properly selected and informed patients鈥�. Bextra has also been associated with reports of 鈥渟erious and potentially life-threatening skin reactions, including death鈥�, it says.
Cox-2 inhibitors were hailed as a revolutionary painkiller for conditions such as arthritis when they first went on sale in 1998. Unlike older NSAIDs, such as aspirin and ibuprofen, Cox-2 inhibitors were thought to be safer to use in certain groups of patients because they did not cause gastrointestinal bleeding and ulcers, and so were prescribed widely.
But Merck, Pfizer and the FDA have been accused of responding too slowly to mounting evidence of the drugs鈥� links to cardiovascular risks. The FDA has also been accused of attempting to hinder the publication of a report of Vioxx鈥檚 side effects, though FDA management denies the allegation.
Pfizer has said in a statement that it disagrees with the FDA鈥檚 decision to withdraw Bextra, although it has complied. It will hold further discussions with the government agency about returning the drug to market.
