Drug withdrawn amid skin concerns

Cox-2s are used to treat pain and inflammation

Sales of a painkiller have been suspended across Europe and the US amid concerns about skin reactions.

There have been 155 reports of adverse reactions to Bextra, commonly used to relieve pain and inflammation from arthritis, worldwide.

The Medicines and Healthcare products Regulatory Agency, the UK regulator, said 40,000 Britons used the drug, and there were two reports of reactions.

The voluntary move was made after talks between makers Pfizer and regulators.

The European Medicines Agency (EMA) said the withdrawal was as an interim measure pending its a review of a class of drugs known as Cox-2 inhibitors - of which Bextra is one.

In deference to the agency's views, the company has agreed to suspend sales of the medicine pending further discussions Pfizer spokesman

Vioxx, another Cox-2 drug, was withdrawn last year due to concerns over a risk of heart attack and stroke.

Only last month EMA officials warned patients who have had heart disease or a stroke not to take a number of Cox-2 drugs, including Bextra.

Professor Gordon Duff, chairman of the UK's Committee on Safety of Medicines, said: "Today's announcement reinforces our previous advice Cox-2s should be used after careful consideration of risks and benefits and the lowest effective dose for the shortest duration of time."

Professor Kent Woods, chief executive of the Medicines and Healthcare products Regulatory Agency, the UK drugs regulator, said he agreed with the move.

"We support the EMA action in advising health professionals and patients of this new safety concern.

"There is no immediate new risk and it is important that we review all available data before reaching a final position."

A Pfizer spokesman said the company "respectfully disagreed" with the regulators' position.

But he added: "In deference to the agency's views, the company has agreed to suspend sales of the medicine pending further discussions."

A spokeswoman for the Arthritis Research Campaign said: "The future of Cox-2 drugs looks very bleak.

"The fact that the regulators have now requested that Bextra be suspended because of these rare but serious skin reactions, provides further damning evidence that the risks of these drugs seem to outweigh the benefits."