London (Reuters) – Europe’s drug agency, concluding a review of COX-2 painkillers, said on Monday it recommended the continued suspension of Pfizer Inc.’s Bextra drug.
The London-based European Medicines Agency said it would review the suspension of Bextra, which was first suspended in Europe and the United States in April, within one year.
The watchdog also reiterated its warnings about the cardiovascular risk associated with COX-2 drugs and the rare serious skin reactions that they could cause.
The drug class has been under review by regulators worldwide since last September, when Merck & Co Inc.’s blockbuster Vioxx was pulled from the market after being linked to an increased risk of heart attacks and stroke.
COX-2 inhibitors belong to a broader class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), whose safety profile will now also be examined by the agency.
Recent research has suggested that traditional NSAIDs, such as ibuprofen, may also increase the risk of heart attacks in some patients.
The agency’s conclusions on COX-2 drugs confirm interim findings issued in February, which advised they should not be given to people with ischemic heart disease or stroke, and that the lowest dose and shortest course should be prescribed.
Pfizer’s top-selling COX-2 drug Celebrex remains on sale in Europe, but the agency said the risks of Bextra outweighed its benefits, because of its association with sometimes fatal skin reactions.
Serious skin reactions can occur with other COX-2 drugs, but have been reported at lower rates than with Bextra.
COX-2 inhibitors work by selectively blocking a protein called COX-2 that has been linked to inflammation. They have a similar ability to fight pain as the older NSAIDs but are gentler on the stomach-a factor which helped make them top sellers following their launch in 1999.
Pfizer and Merck currently dominate the COX-2 market, but other companies are hoping to enter the arena. Novartis AG has a COX-2 drug called Prexige waiting in the wings, while GlaxoSmithKline is working on one known as ‘381.