Warning Over Health Risks of Arthritis Drugs
Posted on: Saturday, 19 February 2005, 03:00 CST
The Irish Medicines Board (IMB) is to issue a warning to GPs about a range of painkillers and anti-inflammatory drugs amid growing concern about their health risks.
It will advise doctors to be cautious about prescribing five drugs, known as Cox 2 inhibitors, to patients who have had strokes or coronary heart disease.
Doctors should also prescribe the lowest effective dose for the shortest possible time, particularly for patients at higher risk because of blood pressure, diabetes or smoking.
Many of the five drugs affected are used to relieve arthritis pain and inflammation. They include Celebrex, Bextra, Dynastat, Arcoxia and Prexige.
The warning follows a meeting of the European Medicines Agency this week. A review of available data it conducted confirmed a risk of cardiovascular side-effects from Cox 2 type drugs, the agency said.
The IMB yesterday said product information had been changed and that GPs would be notified of the changes over the coming week. Patient leaflets will also be distributed in the near future.
Cox 2 drugs are widely used in Ireland, according to industry sources, although the Irish Medicines Board does not maintain figures on how widely the medicines are prescribed.
The board confirmed to The Irish Times that four of the drugs - Celebrex, Bextra, Arcoxia, Dynastat - have been responsible for 55 suspected adverse reactions since they came on the market.
The class of drugs was designed to ease pain as effectively as non-steroidal anti-inflammatory drugs, such as ibuprofen, while being easier on the stomach.
Concerns first arose about Cox 2 drugs when US drug manufacturer Merck pulled its arthritis treatment, Vioxx, off the market last September. This followed studies which showed a higher incidence of cardiovascular problems in people who had been taking it for more than 18 months.
Merck was later accused of trying to cover up the risk for years, an allegation denied by the company.
This prompted the European Medicines Agency to review other Cox 2 type drugs. This week the agency recommended curbs on these drugs, but stopped short of taking them off the market.
Merck, meanwhile, said this week it will consider selling Vioxx again if the US Food and Drug Administration (FDA) decides the cardiovascular risks are similar to those of related prescription pain relievers.
The company's comment came as the FDA held public hearings into the safety of Cox 2 drugs.
Patients suffering from arthritis pleaded with an FDA committee to keep the Cox 2 drugs available.
At the same meeting, FDA scientist Dr David Graham, who has clashed with his employer over monitoring of drug safety, said he felt all Cox 2 inhibitors could cause heart damage and there was little evidence of any health benefit.
His assertions were challenged by some panel members.
Source: Irish Times
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