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.
A federal return 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.
