[an error occurred while processing this directive]
BBC News
watch One-Minute World News
Last Updated: Friday, 22 October, 2004, 09:21 GMT 10:21 UK
Safety probe into arthritis drugs
Image of arthritic hands
Around 9 million people in the UK have arthritis
European regulators are carrying out a safety review following fears that five arthritis drugs could increase the risk of strokes and heart attacks.

Last month, drug company Merck removed its arthritis painkiller Vioxx because of data raising safety concerns.

Now the European Medicines Evaluation Agency will look at five other drugs from the same family as Vioxx - the cyclooxygenase-2 or COX-2 inhibitors.

They are prescribed to around 1.4 million people in the UK.

Strokes and heart attacks

COX-2 inhibitors are more 'stomach friendly' alternatives to traditional pain relief drugs called non-steroidal anti-inflammatory drugs (NSAIDs).

Following a number of adverse reports after Vioxx (rofecoxib) became available in the UK in 1999, the European Committee for Proprietary Medicinal Products looked into the safety of COX-2 drugs.

In 2003, it concluded that the balance of risks and benefits of the products remained positive.

But it recommended strengthening existing warnings about use in patients with underlying cardiovascular risks.

Trial data showing for every 400 people using Vioxx for more than 18 months three would suffer a heart attack or a stroke prompted Merck to withdraw the drug.

It needs to be made very clear that the remaining drugs on the market are entirely safe.
A spokeswoman from the Arthritis Research Campaign

Merck's chairman Raymond Gilmartin said: "Although we believe it would have been possible to continue to market Vioxx with labelling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."

The EMEA will now review available long-term data on cardiovascular safety of all licensed COX-2 inhibitors.

This includes Celebrex (celecoxib), Arcoxia (etoricoxib), Dynastat (parecoxib), Prexige (lumiracoxib) and Bextra (valdecoxib).

The EMEA said it was unclear if the Vioxx data was also relevant for the other COX-2 inhibitors.

"These medicines already contain warnings regarding heart problems. If you have any concerns about your treatment you are advised to consult you prescriber," it advised patients.

A spokesman said: "We have seen one study, from Merck, on rofecoxib. We may actually want to see more studies be done on the other products."

The Department of Health said the UK Committee on Safety of Medicines would cooperate with the European review.

"We will be a part of it," said a spokeswoman.

A spokeswoman from the Arthritis Research Campaign said: "It's very important that the EMEA does look at this otherwise patients will assume that all COX-2 inhibitors are tarred with the same brush as Vioxx.

"It needs to be made very clear that the remaining drugs on the market are entirely safe so we welcome the move by the EMEA."




BBC NEWS: VIDEO AND AUDIO
Why the drug Vioxx has been withdrawn



SEE ALSO:
Arthritis drugs fail after weeks
01 Aug 04  |  Health
New drugs: new side-effects?
22 Jul 02  |  Breakfast


RELATED INTERNET LINKS:
The BBC is not responsible for the content of external internet sites


PRODUCTS AND SERVICES

News Front Page | Africa | Americas | Asia-Pacific | Europe | Middle East | South Asia
UK | Business | Entertainment | Science/Nature | Technology | Health
Have Your Say | In Pictures | Week at a Glance | Country Profiles | In Depth | Programmes
Americas Africa Europe Middle East South Asia Asia Pacific