OTC pain pills targeted

WASHINGTON — Federal health officials cautioned Tuesday the tens of millions of Americans who take popular over-the-counter pain pills of their potentially serious side effects and released planned label changes intended to warn of the sometimes deadly risks.

Aspirin, ibuprofen, acetaminophen and the other related over-the-counter drugs remain safe and effective when used as directed, the Food and Drug Administration said.

However, overdoses of acetaminophen can cause serious liver damage, even death, the FDA said. For aspirin, ibuprofen and other nonsteroidal anti-inflammatory drugs, there is a risk of gastrointestinal bleeding and kidney injury even when patients take the correct dose. Those risks too are linked to deaths, in this case thousands each year. The FDA cautioned the risk is rare when compared to the number of patients who take the drugs.

Experts called the stepped-up warnings long overdue, since federal advisers had called for similar label changes in 2002. An FDA official chalked it up to the time required to write new regulations.

"Unfortunately, that is a very long process. That is one of the disadvantages of the rule-making process," said Dr. Charles Ganley, director of the FDA office that oversees nonprescription products.

The drugs are found in hundreds of medicines sold to treat pain, headache and fever. Health officials worry that the wide availability of those combination products can lead to patients unintentionally overdosing. Doctors report cases of patients taking two or more medicines — say, one for pain and another for flu symptoms — without knowing they both contain acetaminophen.

The FDA has updated the labels on the drugs multiple times in the past to warn patients of their risks. In 2002, FDA advisers recommended even further changes. In 2004, some of the warnings contained in the new proposal were included in pharmacy brochures and public service ads — a move that some critics said at the time didn't go far enough.

The latest proposed changes largely would beef up and highlight those warnings on the labels of the drugs. They also would require the more prominent disclosure, using fluorescent or bold-faced type, the presence of the drugs among a medication's ingredients.

"It's a step that's overdue and really reflects the consensus that came out of the meeting four years ago, which is helping the consumer know what they are taking," said Dr. Paul Watkins, a professor of medicine at The University of North Carolina at Chapel Hill and a member of the 2002 advisory panel.