This article is more than 5 years old. Information may no longer be current.

FDA advisory panel recommends COX-2 inhibitors remain on market

Panel recognizes the increased risk of cardiovascular events and recommends strong restrictions on marketing and use.

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The Arthritis and the Drug Safety and Risk Management advisory committees to the Food and Drug Administration has recommended that COX-2 inhibitors remain on the market. The committees also recommended that the FDA consider allowing rofecoxib back on the market in a limited capacity.

However, the committees further recommended restrictions on the marketing and use of these drugs, recognizing that they do place patients at increased risk for cardiovascular events.

The FDA had convened the joint advisory committee meeting to consider the safety of COX-2 inhibitors, which were created to relieve pain in patients at high risk for gastrointestinal events from nonselective nonsteroidal anti-inflammatory drugs.

Emerging data began to show potential for increased risks of cardiovascular events from use of these agents, and experts questioned their safety. In September, Merck & Co. recalled its COX-2 inhibitor rofecoxib due to safety concerns. The advisory panel, which met Feb. 16 though Feb. 18, voted 17-15 to recommend that rofecoxib should return with significant restrictions. Panel members unanimously agreed that rofecoxib significantly increased the risk of cardiovascular events, and if it were to return to the market it would have to follow strict prescribing rules, including a potential black box warning.

So far, Merck has no plans to return rofecoxib to the market. "Merck has not altered its position on the voluntary withdrawal of Vioxx. Anything further would be speculation," Peter Kim, PhD, president of Merck Research Laboratories, said in a written statement released after the meeting.

Celecoxib

The panel also unanimously agreed that celecoxib (Celebrex, Pfizer) increased the risk of cardiovascular events, but decided in a 31-1 vote that it should remain available.

"These drugs in fact do place patients at an increased risk for heart attack or death, but the actual increase in risk is not such that these drugs should be taken out of the hands of physicians and their well-informed patients to use as a last resort," said panel member Susan M. Manzi, MD, associate professor of medicine at the University of Pittsburgh School of Medicine. Panel members did not agree on whether celecoxib should be used as a "last resort," but recommended that to remain on the market, celecoxib should adhere to the following: (1) forego direct-to-consumer advertising; (2) include a potential black box warning on packaging; and (3) include a patient-friendly medication guide and labeling with strong warnings on dose dependent toxicity. However, at least one panel member wondered about the FDA's ability to enforce these measures. "One reason for my 'no' vote was the time lag issue," said Arthur Levin, MPH, director of the Center for Medical Consumers in New York. "Whatever we recommend today, you're not going to see it in the next couple of months, and I'm concerned about the FDA's ability to limit the distribution of this drug to appropriate patients."

Valdecoxib

When asked to consider valdecoxib (Bextra, Pfizer), panel members voted 32-0 that the drug increased the risk of cardiovascular events, and 17-13, with two abstentions, that the agent should remain on the market.

"I'm not sure that the current data we have does support marketing in the United States; in fact it does not. We've got a very clear safety signal in two studies. We've got a lack of clear benefit. If this drug is going to continue to be marketed we need much better data," said panel chairman Alastair J.J. Wood, MD, professor of pharmacology at Vanderbilt University Medical Center in Nashville, Tenn.

Panel members were most concerned about the effect the agent might have on patients undergoing coronary artery bypass graft. They insisted the label contain a strong contraindication to remain on the market.

Those supportive of valdecoxib said physicians needed an option for postsurgical use, but agreed it should be contraindicated for cardiac surgery.

FDA Advisory panel recommendations are not binding, but the agency historically follows their advice.