* Combo OTC medications should stay on market, cos say
* FDA advisers weigh possible changes to some pain drugs
* Agency's outside advisers to vote Tuesday
ADELPHI, Md., June 29 (Reuters) - Johnson & Johnson, Procter & Gamble and other makers of acetaminophen products said on Monday cough and cold medicines containing the pain reliever should remain on the market despite concerns from U.S. health regulators.
While the Food and Drug Administration is weighing a ban on such combination products -- often marketed to consumers with colds, congestion or other mild illnesses, the industry instead urged a widespread effort to warn buyers about the risks of liver damage linked to the pain 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 warnings about the risk earlier this year but is seeking advice from outside advisers 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 such combination products could dent the sales of acetaminophen-containing products, which overall saw $2.6 billion in 2008 sales, the FDA said, citing IMS Health data. 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 according to CHPA makes up 27 percent of the sector with its Tylenol acetaminophen brand as well as its Sudafed and Benadryl products.
Other makers of acetaminophen products including Bayer AG, GlaxoSmithKline , Novartis , Perrigo Co , Schering Plough and Wyeth . Cadence Pharmaceuticals Inc is also seeking FDA approval to sell an injectable form of acetaminophen.
Other possible FDA actions include repackaging products into single-dose units rather than making patients measure out medications themselves as well as including a strong, black-box warning on prescription products.
Various industry representatives said the bulk of overdoses are intentional by people trying to commit suicide and that more related deaths were seen with prescription acetaminophen drugs than over-the-counter versions.
In April, the FDA ordered bolder warnings about the liver damage risk with acetaminophen products to highlight them better for consumers, and companies agreed to comply.
But a further ban on certain products would be "overly drastic," Paul Desjardins, a vice president for Wyeth Consumer Healthcare, told Reuters. Wyeth's nonprescription Robitussin Cough Cold & Flu and Dristan Cold products have acetaminophen.
Products that combine the ingredient with cold and other drugs help consumers avoid juggling multiple pills and liquids, industry representatives said. Forcing people to go back to taking each medication separately may cause more complications, they added.
Instead, CHPA's Suydam said signs on store shelves and other efforts to target consumers directly could help, adding that pharmacists and drug store chains also support such an effort.
The companies did support some smaller FDA steps such as making sure products come with proper items to measure doses as well as including more detailed information for children younger than 2.
Edwin Kuffner, McNeil's senior director for medical affairs, said his company recommended changing the instructions on adult medications from taking two tablets every four to six hours to advising patients to try one tablet first.
Pictures on product labels may also help, he added.
On Tuesday, the FDA panel will hear from other experts before providing its recommendation to the agency, which usually follows the advice of its panelists. (Reporting by Susan Heavey, editing by Matthew Lewis)
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