The above headline comes from a story in the Chicago Sun-Times and reports on stronger proposed warnings that the US Food and Drug Administration (FDA) is calling for on common pain medication. The story starts on an ominous note, “WARNING: Over-the-counter pain-killers such Tylenol, Advil and aspirin can cause potentially fatal liver damage or stomach bleeding.”
The proposed FDA warnings include acetaminophen and non-steroidal anti-inflammatory drugs, or NSAIDs, including aspirin, naproxen and ibuprofen. This includes some of the most popular over the counter drugs such as Tylenol, Aleve, Motrin and Advil. According to the story, the FDA warnings would, “include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor.”
A Washington-based consumer advocacy group, the Public Citizen, claims that the warnings have come decades later than they should have. In 2002 federal advisers to the FDA had called for similar label changes. Dr. Paul Watkins, a professor of medicine at The University of North Carolina at Chapel Hill and a member of the 2002 advisory panel commented, “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.”
The news stories on this issue report on the scale of this problem noting that 48 million Americans take an acetaminophen product weekly. Some 56,000 people wind up in the emergency room yearly from problems related to this drug, and about 100 people die yearly after unintentionally overdosing. The recommended FDA labels would warn of the risk of severe liver damage for patients taking more than the recommended dose or who consume three or more drinks a day while on the drugs. The FDA would also warn patients not to take multiple medicines that contain acetaminophen.
As far as aspirin, ibuprofen, naproxen and other non-steroidal anti-inflammatory drugs, the additional FDA warnings would stress the risk of stomach bleeding. According to the article, 17 million Americans take an NSAID daily. These drugs, sold as aspirin, Advil and Motrin and Aleve as well as in generic forms, send more than 200,000 Americans to the hospital yearly, and are linked to 16,000 deaths.