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FDA considers change to Tylenol dosages

Panel begins vote on recommendations for acetaminophen. Combination drugs like NyQuil could be pulled from stores.

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(CNN) -- A government advisory panel began voting Tuesday on recommendations for reducing the risk of serious liver injury associated with acetaminophen, found in over-the-counter drugs such as Tylenol and NyQuil.

The panel, assembled by the Food and Drug Administration, is weighing several options, including reducing recommended dosages of acetaminophen or pulling combination drugs, such as NyQuil, from stores' shelves entirely.

After voting on nine options, the panel will be asked to rank the recommendations in order of importance for over-the-counter medications and, separately, for prescription medications.

Its final recommendations will come from that vote, the FDA said.

Although it is one of the most commonly used drugs in the United States for treating pain and fever, overdoses of acetaminophen have been linked to 56,000 emergency room visits, 26,000 hospitalizations and 458 deaths during the 1990s, according to the FDA, citing one study.

The agency cited another study, a 2007 Centers for Disease Control and Prevention population-based report, that estimated that acetaminophen was the likely cause of most of the estimated 1,600 acute liver failures each year.

The advisory panel could vote to pull over-the-counter drugs that use acetaminophen in combination with other ingredients that treat flu and cold symptoms, allergies or sleeplessness.

These combination drugs include NyQuil, Pamprin and Allerest.

The FDA is not required to follow the recommendations of its advisory committees, although the agency typically does.

The Consumer Healthcare Products Association (CHPA), an over-the-counter trade organization, said in a briefing memo that combination over-the-counter drugs comprise only a small portion of acetaminophen overdoses.

"Serious liver injuries are rarely due to OTC combination products (less than 10 percent of all cases), with many more cases attributable to Rx combination products. CHPA strongly opposes the elimination of OTC acetaminophen containing combination products," the organization wrote. To top of page

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