Black Box, Mixed Message? FDA Panel Delivers Acetaminophen Recommendations

Company Disagrees With Dose Recommendations for Acetaminophen

The committee voted 24 to 13 to recommend making the 500 mg pill available by prescription only. So, in order to get former maximum dose of 1,000 mg of acetaminophen at one time, a patient would need a prescription.

The dosage restrictions prompted dismay from McNeil Consumer Healthcare, the makers of Tylenol.

"McNeil Consumer Healthcare strongly disagrees with the committee's recommendation," the company said in a statement. "McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-the-counter products such as non-steroidal anti-inflammatory drugs (NSAIDS) in search of pain relief."

No matter the final outcome of the recommendations, however, consumers will still be able to get acetaminophen. Twenty-nine billion extended units (tablets/capsules/milliliters) of prescription and over-the-counter, acetaminophen-containing products were sold through retail and non-retail pharmacies in 2005, according to the FDA.

The FDA has struggled with the issue of acetaminophen's safety since at least 1977, when an agency committee suggested that labels for pain relievers contain a warning that they can damage a patient's liver.

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