FDA Panel Moves to Decrease Painkiller Dosage
experts say the maximum dose listed for Tylenol and dozens of other
painkillers should be reduced to help curb deadly overdoses.
A Food and
Drug Administration (FDA) panel endorsed lowering the maximum dose of
over-the-counter acetaminophen — the key ingredient in Tylenol,
Excedrin and other medications.
is one of the most widely used drugs in the U.S. Many patients find it
easier on the stomach than other painkillers like ibuprofen and
aspirin, which can cause ulcers.
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.
voted 21-16 to lower the current maximum daily dose of nonprescription
acetaminophen, which is 4 grams, or eight pills of a medication like
Extra Strength Tylenol.
The group was not asked to recommend an alternative maximum daily dose.
also voted 24-13 to limit the maximum single dose of the drug to 650
milligrams. The current single dose of Extra Strength Tylenol is 1,000
milligrams, or two tablets.
In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.
However, some experts complained the measure would create unnecessary work for doctors and patients.
"I think the
drain on the health care system, which is already strained, would be
enormous," said Dr. Robert Kerns of Yale University.
The FDA is not required to follow the group's advice, though it usually does.
scheduled to vote later Tuesday on other safety restrictions for the
drugs — including possibly pulling some products off the market.
Questions on Combination Drugs
that could be withdrawn are combination medications, such as Procter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 says
patients often pair the cold medications with pure acetaminophen drugs,
like Tylenol, exposing themselves to unsafe levels of the drug.
industry group that represents Johnson & Johnson, Wyeth and other
companies defended the products, saying they pose a relatively small
risk to patients.
percent of deaths linked to acetaminophen medications involved
over-the-counter combination cold medications, according to the
Consumer Healthcare Products Association.
of deaths were caused by either single-ingredient drugs or prescription
strength combination drugs like Endo Pharmaceutical's Percocet, which
combines oxycodone and acetaminophen.
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, according to IMS Health, a
health care analysis firm.
there is a clear health benefit of over-the-counter combination
products containing acetaminophen," Linda Suydam, the group's
For more information on the FDA, visit www.fda.gov.