FDA keeping options open on Naproxen

The head of the U.S. drug safety agency said on Tuesday the United States was keeping "all regulatory options open" as it studied data showing increased heart risks from some painkillers.

U.S. health regulators warned on Monday of heart risks connected to over-the-counter painkiller naproxen, which is sold as a generic and under several brand names, including Bayer AG's Aleve, and as Roche AG subsidiary Roche Palo Alto's Naprosyn.

The warning follows studies showing increased heart risks in two other prescription painkillers - Merck & Co. Inc.'s Vioxx, which the company has withdrawn, and Pfizer Inc.'s Celebrex, which is still on the market.

"We are trying to process all the data that we have and make some determinations as quickly as possible," Acting Food and Drug Administration Commissioner Lester Crawford told NBC television's "Today" show.

"It would be premature to say what we are going to do with either one of these drugs, Celebrex or Aleve," he said. "We will keep all regulatory options open and make some determinations as quickly as possible based on the data."

DATA UNCLEAR

The recent burst of new data is unclear, at least one rheumatologist told Reuters, and doctors may have to closely match painkillers to patients based on their medical histories.

"It's really confusing for us and our patients," said Dr. Gregory Gardner, a rheumatologist who studies joint, muscle and bone-related diseases at the University of Washington in Seattle.

Naproxen and Celebrex are in a group of drugs called non-steroidal anti-inflammatory drugs (NSAID), which include aspirin and ibuprofen. Within that group, Vioxx and Celebrex are part of a class known as Cox-2 inhibitors, along with Pfizer's Bextra.

Older drugs like aspirin can cause stomach bleeding and ulcers. Newer Cox-2s were designed to prevent such gastrointestinal side effects.

Some medical experts had suspected naproxen might have a beneficial effect on the heart.

When the first signs of a heart risk with Vioxx came to light in 2000, Merck argued the results were skewed by the protective effects of naproxen on other patients taking part in the trial.

Gardner said he would want to see more data on naproxen since it was thought to have a heart-protective effect. "I'm not sure I would change my practices based on a single study," he said.

NIH-FUNDED TRIAL HALTED

The FDA's latest warning stems from a National Institutes of Health-funded trial studying certain anti-inflammatory drugs in patients at risk for Alzheimer's disease. The trial, which included Celebrex, was halted late Friday after early results showed a higher risk of cardiovascular problems.