Arthritis drug fears sparks EU probe

DRUGS similar to the arthritis drug Vioxx, which has been withdrawn because of a possible risk of heart attack and stroke, are to be reviewed by the European Agency for the Evaluation of Medicinal Products (EMEA) on Monday.

Other drugs that may act in the same way as Vioxx are known as cyclooxygenase-2 or COX-2 Inhibitors, which are more ‘stomach friendly’ alternatives to traditional pain relief drugs called non-steroidal anti-inflammatory drugs.

Following a number of adverse reports after Vioxx became available in Britain in 1999, the European Committee for Proprietary Medicinal Products examined the safety of COX-2 drugs. In 2003 it concluded the balance of the risks and benefits of the products remained positive but recommended strengthening existing warnings about underlying cardiovascular risks.

The EMEA’s Scientific Committee will meet on Monday in the Netherlands to review the COX-2 drugs. The committee includes a medical expert from the Irish Medicines Board.

Pharmaceutical giant Merck decided on Thursday to pull Vioxx from the shelves when a three-year trial showed there was an increased risk of heart attack and stroke after 18 months of treatment.

The company said it believed a voluntary withdrawal of the drug was the “responsible” course to take.

It is not known how many Irish people are taking Vioxx, but the Irish Arthritis Foundation believe the number is “significant”.

Figures supplied by the General Medical Services (Payments) Board show it was prescribed 117,428 times to medical card patients last year, a number of which would be repeat prescriptions.

Dr Niall Ó Cléirigh of the Irish College of General Practitioners said COX-2 drugs were hailed as a significant breakthrough.

He said it was to be expected that the spotlight would now fall on the COX-2 drugs but stressed that there was, as yet, no cause for alarm about this group of drugs.

Dr Ó Cléirigh pointed out that a few years ago a statin - a cholesterol lowering drug - was withdrawn but no other statins were affected.

It would be a far more serious situation if all the COX-2s were implicated, said Dr Ó Cléirigh.

Irish Arthritis Foundation chief executive Mary Rose Tobin said their medical directors have advised that people should stop taking Vioxx and see their GP.

In the meantime, between seeing their GP, people could revert to anti-inflammatory drugs they took before or use paracetamol to control any pain until they could get! a new prescription.