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Agreeing with FDA Actions on Acetaminophen

In June 2009 the FDA convened 37 health professionals who serve on three of its advisory committees to address concerns regarding acetaminophen. My editorial in the July 2009 issue of The Pharmacist Activist identifies many of the recommendations of the advisory committees, and also includes my responses/observations. The advisory committee statements are recommendations and do not become policy until the FDA approves them, which it has not done.

Interestingly, the action that the FDA just announced addresses just one component of a much larger picture. The recommendation applies only to prescription products that contain acetaminophen in combination with other medications (almost always a narcotic [also known as an opioid]).  The recommendation does not pertain to nonprescription (OTC) products such as those available under the Tylenol brand name.

I fully agree with the action that the FDA has just taken. At the present time prescription combination products that contain a narcotic and acetaminophen may contain widely varying amounts of acetaminophen (e.g., 325 mg, 500 mg, 650 mg, 750 mg). The narcotic component of the combination is a much more potent pain killer than acetaminophen and is also associated with a greater number of risks.

As a result, many may overlook the inclusion of acetaminophen in the product or not be attentive to its quantity in each tablet or capsule.  This could result in the use of an excessive dosage/quantity of acetaminophen, even when the amount of the narcotic may be appropriate.  The use of excessive amounts of acetaminophen may result in serious liver toxicity and even death.

By limiting the amount of acetaminophen (to 325 mg) that may be included in prescription combination products that also contain a narcotic, the FDA will be providing greater clarity and safety with respect to the use of these products.

Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy.




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