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.


We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Bextra, Celebrex MDL judge sets first Bextra trial

On the heels of the $4.85 Billion Vioxx settlement, the Multi-District Litigation (MDL) Court for the...

End Conflicts on FDA Approvals

In the coming weeks, the U.S. House and Senate will have to reconcile bills they passed that give the...

Frank Woodson on the Additional Costs and Hidden...

Frank Woodson and David Miceli discuss the additional costs and hidden dangers associated with COX-2...

Cox-2 Inhibitors

What are Cox-2 inhibitors? Our law firm has been in the forefront of the effort to have all of the...


What is Bextra? Bextra is valdecoxib-based drug that is administered orally. Bextra is used as...

Consumer Group says Celebrex Ad Downplays Risks

Pfizer had stopped advertising for the arthritis drug after Merck & Co. Inc.'s rival drug Vioxx was...

Thank you for all your hard work

Thank you for all your hard work over the past years on my behalf and so many others. God bless you all.