People who consume three or more alcoholic drinks per day will be told to consult their doctor' before taking the medication, and that chronic heavy drinkers may be at "increased risk of liver damage."
Among those who have suffered serious side effects is Antonio Benedi. A former aide to President Bush, he won $8 million from the makers of Tylenol after he combined the medication with wine drinking and ended up with a liver transplant.
Dr. Ron Busutill, a transplant specialist at UCLA medical center, sees many such cases.
"We have seen patients who have chronically ingested alcohol and then taken acetaminophen for a back problem or a chronic pain problem and then that combination results in liver failure," said Dr. Busutill.
Tylenol is not the only drug with new warnings.
Motrin, which contains ibuprofen, now highlights an "increased risk of stomach bleeding" when combined with alcohol. However, the company that makes both medications, says occasional drinkers have no need to worry.
"You need to be consuming heavy amounts of alcohol over a period of time before you increase your risk," said Dr. Anthony Temple of McNeil Home Products.
Tylenol and Motrin have voluntarily changed their labels. But the FDA is so concerned that consumers know the possible side effects of over the counter painkillers that it will soon require all of them to carry warnings about the dangers of alcohol and analgesics.
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