Drug cos at odds with FDA over acetaminophen risk

By Susan Heavey

ADELPHI, Maryland (Reuters) - Johnson & Johnson, Procter & Gamble and other manufacturers on Monday said cough and cold drugs with the pain reliever acetaminophen should stay on the market despite concerns from U.S. regulators.

While the Food and Drug Administration is weighing a ban on such combination products -- often marketed to consumers with colds or other mild illnesses, the industry instead urged a widespread effort to warn buyers about the risks of liver damage linked to the ingredient.

"We believe there is a clear public health benefit with OTC (over-the-counter) products containing acetaminophen," Consumer Healthcare Products Association (CHPA) President Linda Suydam, whose group represents the two companies along with others, told an FDA advisory panel meeting to discuss the risks.

Too much acetaminophen has been known to cause liver injury for decades, but FDA officials are worried that the rise of products that combine it with other medications can lead consumers unknowingly to overdose by taking too much of a medication or taking too many different products at once.

The agency called for stronger liver warnings earlier this year but is seeking advice from outside experts at a two-day meeting on whether such over-the-counter and prescription combination drugs can safely remain on the U.S. market.

A total ban on combination products could dent sales of acetaminophen-containing products, which were $2.6 billion in 2008, the FDA said, citing IMS Health. Nearly 80 percent of that stems from combination products sold directly to consumers, it said.

Impact could be especially significant for Johnson & Johnson's McNeil Consumer Healthcare division, which CHPA said makes up 27 percent of the sector with its Tylenol brand as well as its Sudafed and Benadryl products.

Some of Procter & Gamble's NyQuil, Vicks Formula 44 and other nonprescription medications contain acetaminophen. Other companies that make related products include Bayer AG, GlaxoSmithKline, Novartis, Perrigo Co, Schering Plough and Wyeth.