Rofecoxib’s adverse heart effects may have been identified years earlier

WASHINGTON - A new American report suggests that clinical trial data had pointed out the association between the anti-inflammatory drug rofecoxib and cardiovascular risk nearly eight years ago.

The report notes that Rofecoxib had launched in May 1999 with the brand name Vioxx. It had soon become a commercial success, grossing about 2 billion dollars in annual sale.

However, concerns over the medication’s cardiovascular risks had existed even while the drug was being developed.

September 2004 had seen the manufacturer withdraw the drug from the markets.

Joseph S. Ross of Mount Sinai School of Medicine, New York and his team examined published and unpublished clinical trial data arising out of tests done by the manufacturer before September 2004.

The researchers took note of 30 randomized, placebo-controlled trials in which 20,152 individuals had participated.

“As of December 2000, 21 of these trials had been completed (70 percent) and the risk of a cardiovascular thromboembolic [heart- or blood clot-related] adverse event or death was greater among subjects assigned to the rofecoxib group, raising concerns from a safety standpoint,” the authors said.

“Subsequently collected data through June 2001 showed that rofecoxib was associated with a 35-percent increased risk of a cardiovascular thromboembolic adverse event or death.”

Pooled analysis as of September 2004, showed a 43percent increased risk.

The authors said: “Physicians and the public deserve to be in a position to make informed choices about risks and benefits, and the disclosure and dissemination of information about potential risk immediately after its recognition is absolutely essential. Our study provides insight into what should have been known about the risks of rofecoxib.

They add: “If we are to detect harms early and protect the public’s health, while ensuring the availability of new, clinically effective therapeutics, a system must be established that makes full use of all existing evidence.”

The report has appeared in the November 23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. (ANI)