Safety review ordered into popular painkillers

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A European medicines regulator will today order a safety review of four powerful painkilling drugs taken by more than 750,000 people in Britain amid fears that they could increase the risk of heart attacks and strokes.

A European medicines regulator will today order a safety review of four powerful painkilling drugs taken by more than 750,000 people in Britain amid fears that they could increase the risk of heart attacks and strokes.

The European Medicines Evaluation Agency (EMEA) will announce a review of the Cox-2 inhibitors class of drugs, used to treat pain caused by arthritis and other conditions.

The move follows the decision last month by the US company Merck and Co to remove Vioxx, a Cox-2 painkiller, from worldwide sale in the largest prescription drug withdrawal in history.

Some 666,000 prescriptions were written for Vioxx in the year to June 2004 in the UK, bringing to 1.4 million the total number of people who received prescriptions for Cox-2 painkillers in the last year.

Vioxx was withdrawn after evidence came to light that it almost doubled the risk of heart attacks and stroke in people who had been taking it for 18 months. A report from the US Food and Drugs Administration suggested that Vioxx may have caused more than 27,000 heart attacks in the four years it had been on the market, of which 7,000 may have been fatal.

In the UK, four other Cox-2 inhibitors remain on the market. Celebrex and Bextra, both made by Pfizer, were prescribed to 585,000 and 23,000 patients respectively in the year to last June. Arcoxia, made by Merck Sharp and Dohme, the UK arm of the Vioxx manufacturer Merck and Co, was prescribed to 172,000 patients.

A fourth drug, Dynastat, is used in hospital for treating pain following surgery and is unlikely to be prescribed by GPs.

The EMEA last reviewed the Cox-2 inhibitors in November 2003 and concluded that "the overall benefits outweighed the risk of side-effects in the target patient population". But it ordered strengthened warnings on the risk to patients with known gastrointestinal or heart problems.

Yesterday, the Department of Health said the UK Committee on the Safety of Medicines would co-operate with the European review. "We will be a part of it," a spokeswoman said.

The Cox-2 inhibitors were launched in the late 1990s and were claimed to have powerful painkilling properties without damaging the stomach - which can happen with ordinary painkillers such as aspirin and ibuprofen.

Launched in 1999, Vioxx became one of the most heavily promoted prescription drugs, and was marketed in 80 countries with annual sales of $2.5bn (£1.4bn). After its withdrawal, researchers alleged that all the companies making the Cox-2 painkillers had known of the potential heart risk but had failed to run the necessary trials to ascertain the danger.

Richard Horton, editor of The Lancet, described it as a "public health emergency" and said it raised "grievous questions about the adequacy of our drug regulatory system".

Garrett Fitzgerald, professor of medicine and pharmacology at the University of Pennsylvania, wrote in The New England Journal of Medicine: "The basis for addressing the cardiovascular effects of these drugs has been clear for the past five years, yet even the most fundamental questions have not been addressed directly."

Last week Pfizer, manufacturer of Celebrex, announced that it was setting up a trial which would include examination of the cardiovascular safety of the drug.

* Yesterday Merck told its shareholders that the withdrawal of Vioxx had cost it $553m (£300m) so far. The final cost is likely to top $1bn.

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