Are Your Painkillers Actually Killing You?

Dec. 20, 2006 — -- Calls for stronger warning labels for certain over-the-counter (OTC) medications question the safety of products that are a fixture in the medicine cabinets of nearly every American household.

On Tuesday, the Food and Drug Administration proposed stronger warning labels for acetaminophen, widely known by the brand name Tylenol, and the common class of pain relievers known as nonsteroidal anti-inflammatory drugs, or NSAIDs. This group includes ibuprofen and aspirin.

Considering the familiarity of these medicines, many consumers assume they are safe.

However, the FDA estimates that 200,000 Americans are hospitalized every year because of overdoses and side effects of normal doses of these drugs, and they are the cause of thousands of deaths per year.

"Too many people assume these drugs are 100 percent safe because they are available over the counter," said Dr. Roshini Rajapaksa, assistant professor of medicine in New York University School of Medicine's division of gastroenterology.

The drugs can also cause gastrointestinal problems and liver damage.

"In people over 60, the most common cause of gastritis, peptic ulcers and upper [gastrointestinal] bleeding is the use of NSAIDs," said Dr. Joel Weinstock, professor and chief of the division of gastroenterology and hepatology at Tufts New England Medical Center in Boston.

Weinstock adds that acetaminophen also has dangers.

"Use of Tylenol, particularly with alcohol, can readily cause hepatitis and liver failure," he said. "This happens frequently. Some of these patients will require liver transplant because the damage to the liver is so severe."

"If these drugs had just come to the market today, I would not be surprised if they would require prescriptions and would not be available for over-the-counter sale," Weinstock said.

Prominent manufacturers and distributors of pain relievers have expressed their willingness to adhere to enhanced labeling requirements.

In a statement issued Tuesday, McNeil Consumer Healthcare, the makers of the acetaminophen pill Tylenol and the ibuprofen drug Motrin, said they had "previously implemented a number of the proposals in the FDA OTC monograph labeling recommendations released today, and will continue to work with the FDA to ensure appropriate information is provided to consumers."