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Winter 2010

FDA Weighs Acetaminophen Recommendations


Concern about accidental acetaminophen poisoning has led a U.S. Food and Drug Administration (FDA) advisory panel to call for significant changes in the way the drug is made available in this country.

Unbeknownst to many users, acetaminophen is also an ingredient in a number of commonly consumed over-the-counter drugs, such as cough and cold medicines, and in some prescription pain medications. As a result, says Thomas Strouse, M.D., medical director of the Stewart and Lynda Resnick Neuropsychiatric Hospital at UCLA, many people who stay within the recommended level of acetaminophen use don’t realize they are exceeding the limit by also taking these other medications.

For example, the pain reliever Vicodin contains acetaminophen combined with the opioid hydrocodone, and Percocet, another pain medication, combines acetaminophen with oxycodone. Eliminating these and other combination products would mean doctors would have to prescribe the opioids apart from acetaminophen; they could also recommend that their patients purchase acetaminophen over the counter for the combined effect, Dr. Strouse explains.

The proposed move by the FDA to separate acetaminophen from these other medications is not without detractors. Scientific organizations such as the American Pain Society and patient-advocacy groups assert that it could reduce the appropriate use of opioids for pain, at least in the short term, since physicians would no longer be able to easily order these common medications. Others worry that taking acetaminophen out of these combination products could remove a potential deterrent for prescription-drug abusers who might currently be limiting their intake because of their knowledge about the risk of liver damage.

“This is a complex public-policy issue,” says Dr. Strouse, who notes the potential upside: “We would be eliminating a significant source of acetaminophen exposure in patients who are taking opioids either appropriately or who are abusing them.”

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