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By Paula Moyer
DALLAS, Mar 28 (Reuters Health) - Liver failure due to a toxic dose of acetaminophen--the active ingredient in Tylenol and many cold medications--may be more common than previously thought, according to Dr. William Lee, a hepatologist and professor of internal medicine at University of Texas Southwestern Medical Center in Dallas.
Lee's research and other findings from the United Kingdom have prompted the US Food and Drug Administration (FDA) to begin investigating whether more explicit warnings are needed on medications containing acetaminophen.
"People have no fear of acetaminophen and are consuming too much. They accidentally poison themselves by either taking too many pills in too short a time, or by taking several different preparations, all of which contain acetaminophen," Lee told Reuters Health. For example, a person may cope with a cold by taking a syrup to suppress the cough and tablets for pain relief, without knowing that both contain acetaminophen.
To avoid ingesting a toxic dose, patients or their parents should read the labels and package inserts of all over-the-counter and prescription medications. If both contain acetaminophen, the patient should seek direction from a physician or pharmacist to avoid an inadvertent overdose.
But recommendations on safe daily dosage vary. According to Lee, the total combined acetaminophen dose from all medications should not exceed 2 grams daily. Tylenol maker McNeil Consumer Healthcare warns consumers not to take more than eight 500 mg Tylenol tablets in 24 hours, for a maximum recommended dosage of 4 grams daily.
In previously published research, Lee and colleagues followed 295 patients who had had liver failure. Acetaminophen overdose was the most common identified cause, affecting 60 patients, or 20% of the group.
The type of post-market monitoring FDA is undertaking for Tylenol is actually fairly routine, according to spokesperson Susan Cruzan.
"FDA continues to monitor drugs already on the market all the time," Cruzan told Reuters Health. "The latest acetaminophen warning two years ago was regarding alcohol, cautioning against its use in combination with more than three alcoholic drinks per day."
FDA is now reviewing its own adverse drug event reporting system to determine what the data show regarding acetaminophen, she said. "If we determine that there's a problem that can be corrected with labeling or education, then we'll decide whether those steps are necessary," she told Reuters Health.
According to McNeil Consumer Healthcare, liver failure can only occur with substantial overdoses. "These new data do not suggest that acetaminophen is anything but a good over-the-counter analgesic," the company's vice president, Dr. Anthony Temple, told Reuters Health.
"However, people need to take it as directed, and use it as directed. If the recommended dose is exceeded, a doctor or a poison control center needs to be consulted," Temple noted.
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