Over-the-counter pain-killers such Tylenol, Advil and aspirin can cause potentially fatal liver damage or stomach bleeding.
The Food and Drug Administration on Tuesday proposed that:
- Labels for such drugs as aspirin, ibuprofen (Advil, Motrin) and naproxen (Aleve) warn of the potential for stomach bleeding. These medicines are known as nonsteroidal anti-inflammatory drugs.
- Labels on Tylenol and other acetaminophen products highlight the potential for liver toxicity.
“I’ve been waiting for this for four years,” said Kate Trunk of Ft. Myers, Fla. Trunk’s 23-year-old son, Marcus, died of acetaminophen poisoning.
After spraining his wrist, Marcus took acetaminophen with codeine, as prescribed by his doctor. He then developed flu-like symptoms, dark urine and severe aches. He was admitted to the hospital, where he received more acetaminophen.
Marcus was put on a liver transplant waiting list, but died before an organ became available.
Kate Trunk later told an FDA advisory panel
Kate Trunk later told an FDA advisory panel: “If our son or my husband and I had even an inkling that acetaminophen toxicity existed, I feel that the outcome of our story would be totally different.”
The FDA said the risks are rare when compared to the number of patients who take them.
The drugs are found in hundreds of products sold to treat pain, headache and fever. Health officials worry that the wide availability of those combination products allows patients to unwittingly overdose.
Consumer Healthcare Products Association, an industry trade group, said the drugs “continue to be safe and effective.”
The group added, however, that over-the-counter products “are real medicines with real risks if misused. We reiterate that it is extremely important that consumers know to read and follow the directions.”
The FDA has updated labels multiple times. The latest proposed changes would beef up and highlight those warnings on labels. They also would require more prominent disclosure, using fluorescent or bold type.
The label proposal would take effect in about one year, but the FDA is urging companies to update their labels before that.
A consumer group, Public Citizen, said the FDA’s action is long overdue.