Complain about a product or service

COX-2 Painkillers Restricted in Europe

February 23, 2005
While the U.S. Food and Drug Administration (FDA) considers an expert panel's recommendation that Vioxx be allowed to return to the market, the European Medicines Agency (EMA) has restricted use in the European Union of COX-2 painkillers because of the increased risk of adverse cardiovascular events.

COX-2 Drugs • Bextra • Celebrex • Vioxx --- News • Celebrex May Disrupt Heart Rhythm • FDA Rejects Arcoxia As Arthritis Drug • FDA Panel Rejects Vioxx Replacement • FDA Panel Members Indebted to Drug Companies • COX-2 Painkillers Restricted in Europe • Researchers Ignored Early COX-2 Warnings • FDA to Improve Drug Safety Monitoring • FDA Convenes COX-2 Meeting • FDA Blasts Ads For Celebrex, Bextra • Feds Issue Caution On All COX-2 Drugs • British Heart Patients Told to Stop Taking Cox-2 Drugs • Researchers Warn of Dangers

A federal advisory panel earlier this month gave Merck a yellow light to bring painkiller Vioxx back onto the market, provided it carries a black box warning that it raises the risk of heart attack and stroke.

The EMA approved revisions to the prescribing information for COX-2 painkillers to warn healthcare professionals of the increased risk of adverse cardiovascular events, including myocardial infarction and stroke, associated with their use.

The restrictions apply to medications available in the U.S. such as Celebrex and Bextra, made by Pfizer, as well as COX-2 inhibitors available only in the EU. Use of COX-2 inhibitors is now contraindicated in patients with ischemic heart disease or a history of stroke.

According to the EMA, the available data suggest an association between COX-2 inhibitor exposure and cardiovascular risk. Use of these medications should therefore be restricted to the lowest effective dose for the shortest possible duration of treatment.

The EMA advises caution when prescribing COX-2 inhibitors for patients with risk factors for heart disease, including hypertension, hyperlipidemia, diabetes, peripheral arterial disease, and current smoking.

COX-2 inhibitors are indicated in the EU for the treatment of rheumatoid arthritis and other painful conditions.

Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.

Share		Follow us on Twitter.

Back to the top |