Vaccination News Home Page

http://www.nytimes.com/2002/09/21/health/21ASPI.html?tntemail0

F.D.A. Panel Calls for Stronger Warnings on Aspirin and Related Painkillers

By SHERYL GAY STOLBERG

ILVER SPRING, Md., Sept. 20 — Saying consumers are not being fully informed of the risks of common pain relievers like aspirin and ibuprofen, a panel of experts called today for the Food and Drug Administration to require more explicit warnings.

The committee said certain groups of patients, including the elderly, should be warned that they risk stomach bleeding or kidney failure by taking the class of medicines known as nonsteroidal anti-inflammatory drugs, or Nsaids (pronounced EN-seds). The class includes aspirin; ibuprofen, found in Motrin and Advil; and naproxen, found in Aleve.

"We want to strengthen the overall message to the consumer," Dr. Louis Cantilena, the panel's chairman, said.

The drug agency is expected to follow the advice. The committee's decision came at the end of a two-day session devoted to reviewing the risks of over-the-counter analgesics.

On Thursday, the panel voted overwhelmingly to recommend stronger warnings for acetaminophen, which is the main ingredient in Tylenol and is present in many other medicines. The F.D.A. says thousands of consumers take unintentional overdoses of acetaminophen, resulting in 100 deaths from liver failure each year. So the acetaminophen debate revolved around reducing preventable deaths and injuries among people who mistakenly take too much of the drug, sometimes unwittingly by combining medicines.

Today, by contrast, the committee focused on those people, including the elderly and patients with various medical conditions — like stomach ulcers and heart, kidney or liver disease — who are injured by taking the drugs as directed.

The labels on the various drugs vary greatly, Dr. Cantilena said, with newer drugs, like Aleve, carrying more specific warnings. He said there was a "consistent call" from the committee to make the warnings more uniform. The vast majority of patients who take Nsaids take them without incident. But the risk of stomach bleeding is well documented, even among healthy people.

Among all users of the drugs, Dr. Cantilena said, the risk of stomach bleeding is as much as four times as high as among those who do not take the medicines. The higher the dose, the higher the risk, he said. As for kidney failure, Dr. Cantilena said, the risk is much lower. "But it exists," he said.

Today's debate also turned on a quirk of the drugs: although they are sold over-the-counter as short-term remedies for headaches and colds, millions of Americans take them long-term for two common chronic conditions, heart disease and rheumatoid arthritis. In theory, such patients should be receiving prescriptions from their doctors, who have access to detailed information about the risk of stomach bleeding and kidney failure. But most patients never see those warnings, because they are not included with over-the-counter preparations.

"The question is," Dr. John Jenkins, an F.D.A. official involved in the review, said, "do we need to protect consumers with any additional information?"

Although the committee answered that question in the affirmative, manufacturers were split. Steven Weisman, a medical consultant to Bayer, the aspirin maker, said the company was "very committed to working with the F.D.A.," a sentiment echoed by William McComb, president of McNeil Consumer and Specialty Pharmaceuticals, which sells both Motrin and Tylenol. McNeil has already begun strengthening warnings on those drugs.

But Dr. Roger Berlin, president of global scientific affairs at Wyeth Consumer Healthcare, the maker of Advil, said he was not certain labeling changes would improve patients' health. Dr. Berlin said his company recently conducted a study that examined how well consumers followed Advil's label directions.

The study, which included the elderly and people with poor reading skills, found that more than 90 percent of patients, followed directions correctly, he said. Patients with a history of ulcers or heart disease, for instance, did consult their doctors before taking the drug, a finding that Dr. Berlin said suggested that more specific warnings were not necessary.

Vaccination News Home Page

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.