UPDATE 1-Drug cos at odds with FDA over acetaminophen risk

* 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

(Adds comments, companies, background)

By Susan Heavey

ADELPHI, Md., June 29 (Reuters) - Johnson & Johnson
(JNJ.N), Procter & Gamble (PG.N) 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
BAYG.DE, GlaxoSmithKline (GSK.L), Novartis (NOVN.VX), Perrigo
Co (PRGO.O), Schering Plough SGP.N and Wyeth WYE.N.

Some prescription medications also contain the ingredient,
including Abbott Laboratories' (ABT.N) Vicodin and Endo
Pharmaceuticals' (ENDP.O) Percocet. Cadence Pharmaceuticals Inc
(CADX.O) is also seeking to sell injectable acetaminophen.

Other possible FDA actions include reducing the amount of
medicine sold in packages, lowering the available strengths for
over-the-counter products, and adding a strong, black-box
warning on prescription medications.

Industry representatives said most overdoses result from
people trying to commit suicide and that more deaths were seen
with prescription versions than over-the-counter ones.

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," said Paul Desjardins, a vice president for Wyeth
Consumer Healthcare.

Instead, the FDA should require approval of nonprescription
acetaminophen products before they could be sold, Desjardins
told the panel. Wyeth, known for its widely-used ibuprofen pain
medication Advil, also sells Robitussin Cough Cold & Flu and
Dristan Cold over-the-counter products with acetaminophen.

FDA officials consider the ingredient safe when taken as
directed but worry that the number of liver failure cases that
continue to be reported despite various interventions since the
1990s show "overdose remains a serious public health problem,"
the agency said in a memo released before the meeting.

Estimates vary, but a 2007 Centers for Disease Control and
Prevention report found acetaminophen use was the most common
cause of the estimated 1,600 cases of acute liver failure that
year, the FDA said. Alcohol use and liver disease can also
increase a consumer's risk, experts say.

Products that combine the ingredient with cold and other
drugs help consumers avoid juggling multiple medications and
forcing people to take each drug separately may cause more
complications, industry representatives said.

Edwin Kuffner, McNeil's senior director for medical
affairs, said his company recommended changing the instructions
for adults from taking two tablets every four to six hours to
advising them to try one tablet first.

Panelist Ruth Day, a Duke University researcher, welcomed
some of the industry's proposals but said she still had some
concerns. If consumers cannot find or understand warnings on
over-the-counter products, "what's the point?" she said, adding
that certain label design changes could be an easy fix.

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)