Safety probe into arthritis drugs (Celebrex Arcoxia Dynastat and Bextra)

[Guest guest]

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 four 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 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 in the next two weeks.

This includes Celebrex (celecoxib), Arcoxia (etoricoxib), Dynastat

(parecoxib), Vioxx (rofecoxib) 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.

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. "

She said she was pleased that the review process would only take two

weeks.

http://news.bbc.co.uk/1/hi/health/3944227.stm

[Guest guest]

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 four 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 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 in the next two weeks.

This includes Celebrex (celecoxib), Arcoxia (etoricoxib), Dynastat

(parecoxib), Vioxx (rofecoxib) 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.

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. "

She said she was pleased that the review process would only take two

weeks.

http://news.bbc.co.uk/1/hi/health/3944227.stm