FDA Urges Stronger Painkiller Labeling

Dec. 19, 2006 — -- The Food and Drug Administration pushed today for stronger warning labels for such common over-the-counter painkillers as acetaminophen, aspirin and ibuprofen. The step is the latest FDA effort to caution millions of Americans about the potentially serious health threats posed by these drugs.

"A number of manufacturers of [over-the-counter] internal analgesic drug products already have voluntarily implemented labeling changes to identify these potential safety concerns," the FDA said in an official statement.

The changes would affect the labeling of both the box and the container of the drugs.

The upgraded labels would include important safety information about the potential for stomach bleeding and liver damage, as well as when to consult a doctor.

The new labeling proposals are not the the FDA's first attempt to educate consumers about the dangers of overdosing on acetaminophen. In 2004, a government campaign focused on educating patients about the liver problems that accompany its misuse.

Acetaminophen is the most commonly used drug in the United States, according to the 2005 Sloane Survey on U.S. Medication. About one out of every five American adults take it in any given week. The survey also reports that acetaminophen and ibuprofen are the most commonly used drugs given to U.S. children, with about 20 percent of children 4 years old and younger taking acetaminophen in any given week.

All told, roughly 60 million Americans take acetaminophen each week.

The FDA said over-the-counter drugs remain safe and effective when used as directed. However, acetaminophen taken with alcohol or in large doses can cause serious liver damage.

According to a 1997 study in the medical journal Annals of Internal Medicine, acetaminophen, aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs account for an estimated 7,600 U.S. deaths and 76,000 hospitalizations every year.

Various doctors and health groups have expressed concern over the rising number of acetaminophen-related cases of liver failure. A 2005 study in the journal Hepatology revealed the annual percentage of acute liver failure caused by acetaminophen rose from 28 percent in 1998 to 51 percent in 2003.