The makers of Tylenol, Excedrin and other
medications are trying to dissuade regulators from placing new
restrictions on their popular painkillers, including possibly
removing some of them from store shelves.
The Food and Drug Administration has assembled more than 35
experts to discuss 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 is the leading cause of liver failure in the
U.S., sending 56,000 people to the emergency room annually,
according to the FDA.
The agency on Monday asked its experts to consider a range of
options: adding a "black box" warning label to the products,
lowering the drug dosage in some products, or pulling certain types
of medications off the market.
The drugs that could be pulled off shelves are combination
medications, such as Procter & Gamble's NyQuil or Novartis'
Theraflu, which combine acetaminophen with other ingredients that
treat cough and runny nose.
The FDA says patients often pair them with a pure acetaminophen
medication, like Tylenol, exposing themselves to unsafe levels of
the drug.
But the industry group that represents Johnson & Johnson, 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 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.
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.
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.
J&J also warned panelists that any new restrictions on
acetaminophen would force patients to switch to nonsteroidal
anti-inflammatory drugs, which carry risks of gastrointestinal
bleeding and sometimes fatal kidney injury.
"When switching occurs, the risk of death increases," said Dr.
Kenneth Rothman, a consultant for J&J. According to figures from
Rothman, a 30 percent switch away from acetaminophen would result
in an additional 5,000 deaths per year.
Top-sellers in the anti-inflammatory drug market include Bayer
AG's aspirin and Wyeth's Advil.
Executives from Wyeth scheduled a series of media briefings last
week, arguing there's no evidence that the reduced use of
acetaminophen would cause more negative side effects with their
drug.
"There are major flaws in their arguments that are not born out
in real world experience," said Dr. Paul Desjardins, a vice
president with Wyeth.
Desjardins pointed out that the U.K. has put tighter safety
measures in place for acetaminophen without causing increased
problems with Advil and other nonsteroidal anti-inflammatory drugs.
For its part, the FDA has made clear it will not play king-maker
in the market for over-the-counter medications. The agency says its
only goal is to reduce liver injury, "not to decrease appropriate
acetaminophen use or to drive people to use NSAIDS instead."