Europe Restricts Cox-2 Drugs

Regulators for the European Union say the class of drugs poses increased cardiovascular risks.
Author:
Publish date:

European regulators on Thursday announced restrictions on arthritis drugs known as Cox-2 inhibitors, saying the whole class of drugs poses an increased risk of heart-related injury.

The measures -- termed "urgent safety restrictions" -- were imposed by the European Medicines Agency, which supervises drugs for the European Union.

The restrictions will cover medications that are available in the U.S., such as

Pfizer's (PFE) - Get Report

Celebrex and Bextra, as well as several drugs that aren't sold in the U.S. These drugs include Pfizer's Dynastat,

Novartis'

(NVS) - Get Report

Prexige and

Merck's

(MRK) - Get Report

Arcoxia. Their manufacturers are seeking FDA approval for these products.

"The available data show an increased risk of cardiovascular adverse events for Cox-2 inhibitors as class," the agency said. "The data also suggest an association between the duration and dose of intake and the possibility of suffering a cardiovascular event."

The agency's ruling is considered an interim measure, subject to formal approval in April. The decision comes

as two advisory committees of the Food and Drug Administration are holding three days of hearings to determine what restrictions might be placed on individual Cox-2 inhibitors or on the whole class of drugs.

The FDA has vowed to act quickly after the advisory panels offer their recommendations.

The European drug regulator said doctors shouldn't prescribe any Cox-2 drugs for patients who have suffered a stroke or who have ischemic heart disease, which is caused by a narrowing of coronary arteries. When arteries are narrowed, less blood and oxygen reaches the heart muscle, and that can lead to a heart attack.

The agency also singled out Arcoxia, saying doctors shouldn't prescribe it for patients whose high blood pressure isn't under control.

"Given the association between cardiovascular risk and exposure to Cox-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration," said the agency, which began reviewing the Cox-2 drugs in October. The review was initiated after Merck pulled its Cox-2 drug Vioxx from the market on Sept. 30, citing a higher risk of cardiovascular injury in patients who used the drug for more than 18 months.

Doctors also were exhorted by the European medical agency to "exercise caution" in prescribing Cox-2 drugs for patients who have high blood pressure, high cholesterol, diabetes and peripheral arterial disease. Doctors also were warned about prescribing the drug to patients who smoke.