FDA Panel to Vote on Painkiller Restrictions

ADELPHI, Md. (AP) - Government experts are scheduled to vote on
whether Nyquil and other combination cold medications should be
pulled from the market to help curb deadly overdoses.

The Food and Drug Administration has assembled more than 35
experts for a two-day meeting to discuss and vote on ways to
prevent overdose with acetaminophen - the pain-relieving,
fever-reducing ingredient in Tylenol and dozens of other
prescription and over-the-counter medications.

Despite years of educational campaigns and other federal
actions, acetaminophen remains the leading cause of liver failure
in the U.S., sending 56,000 people to the emergency room annually,
according to the FDA. There are about 200 acetaminophen-related
deaths each year.

"It can happen to anybody, but it's very rare," said Dr. Lee
Simon, an associate professor at Harvard Medical School, who
attended Monday's meeting. "Obviously it's important that we
improve the communication about these products because they are
ubiquitous, and we still see people inadvertently overdosing."

The drugs that could be pulled off shelves are combination
medications, such as Procter & Gamble's NyQuil or Novartis'
Theraflu, which mix acetaminophen with other ingredients that treat
cough and runny nose.

The FDA is not required to follow the advice of its panels,
though it usually does. The panel vote is scheduled for Tuesday
afternoon.

Manufacturers could lose hundreds of millions of dollars in
sales if combination drugs are pulled from the market. Total sales
of all acetaminophen drugs reached $2.6 billion last year, with 80
percent of the market comprised of over-the-counter products.

The FDA says patients often pair the cold medications with pure
acetaminophen drugs, like Tylenol, exposing themselves to unsafe
levels of the drug.

But the industry group that represents Johnson & Johnson,
Advil-maker Wyeth and other companies defended the products Monday,
saying they pose a relatively small risk to patients.

Only 10 percent of deaths linked to acetaminophen medications
involved over-the-counter combination cold medications, according
to the Consumer Healthcare Products Association.

The majority of deaths were caused by either single-ingredient
drugs or prescription strength combination drugs like Endo
Pharmaceutical's Percocet, which combines oxycodone and
acetaminophen.

"We believe there is a clear health benefit of over-the-counter
combination products containing acetaminophen," said Linda Suydam,
the group's president.

Tylenol-maker Johnson & Johnson also pushed back against a
proposal to lower the maximum daily dose of acetaminophen, which is
currently 4 grams daily, or eight pills of a medication like Extra
Strength Tylenol.

While taking more than 4 grams per day can cause liver injury,
J&J argued that taking the exact dose is proven to treat
osteoarthritis pain.

The FDA panel also will vote on a series of other proposals,
including changes to the packaging and labeling of medications.
Both ideas are designed to prevent patients from taking more than
the recommended dose of the drug.


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