Prescription drugs face acetaminophen restrictions

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Acetaminophen, the key ingredient used in over-the-counter (OTC) drugs like Tylenol and Nyquil, will be limited to only 325 milligrams per dose in prescription painkillers such as Vicodin and Percocet, the FDA announced yesterday. These prescription drugs combine acetaminophen with narcotics like oxycodone and hydrocodone, causing potentially toxic acetaminophen overdoses when patients use these medications in conjunction with other OTC acetaminophen-containing drugs. The problem, say FDA officials, is that prescription drug labels do not make it clear that they contain acetaminophen since they often abbreviate the agent as “APAP” — a term many people are unfamiliar with.

Whether knowingly or unknowingly, combining acetaminophen dosages from the joint use of prescription and OTC drugs can have devastating effects on the liver. Approximately 56,000 people are sent to the ER annually due to liver poisoning, and acetaminophen is the leading cause in the U.S., killing between 200 to 500 people.

ACSH’s Dr. Josh Bloom believes the new FDA restrictions are very smart. “Taking OTC and prescription pain-relieving meds containing acetaminophen together can subject you to two-to-three times the therapeutic dose, which can be dangerous, especially if you are taking these drugs chronically or combining them with alcohol.”

Because opiate painkillers can be addictive, people may be taking them in inappropriate amounts, thus causing them to be at higher risk for acetaminophen toxicity, says ACSH's Dr. Gilbert Ross.

Though acetaminophen-containing OTC drugs are exempt from the current restrictions and will be allowed to contain as much as 500 milligrams of the ingredient per pill or capsule, an FDA panel of advisors previously recommended instituting similar limitations against this class of drug as well.