WASHINGTON (AP) - Federal health regulators are limiting a key
ingredient found in Vicodin, Percocet and other prescription
painkillers that have been linked to thousands of cases of liver
damage each year.
The Food and Drug Administration said Thursday it will cap the
amount of acetaminophen in the drugs at 325 milligrams per capsule. Current products on the market contain doses of up to 700
Acetaminophen is a ubiquitous pain reliever found in Tylenol,
Nyquil and thousands of other medicines used to treat headaches,
fever and sore throats. The ingredient is also used at larger doses
in prescription combination drugs that mix it with narcotic drugs
Those products are not dangerous by themselves but can cause
toxic overdoses when patients combine them with a second
acetaminophen-containing drug like Tylenol.
FDA officials said the labeling on prescription drugs often does
not make it clear that they contain acetaminophen, instead using
abbreviations for the ingredient like 'APAP.'
"One of the real challenges we have is that patients taking
these products don't know they're taking acetaminophen at all,"
said FDA deputy director for new drugs, Dr. Sandra Kweder, in a
telephone briefing with reporters "They don't realize that they
The FDA said it is working with pharmacies and other medical
groups to develop standard labeling for acetaminophen, though that
is not part of Thursday's action.
Agency officials said the drugs will still be effective at lower
"The amount of acetaminophen in these products has gradually
crept up over the years," Kweder said. "If you look at these
products 20 to 30 years ago, many did not contain high doses of
The restrictions announced Thursday will not affect
over-the-counter products like Tylenol and Theraflu. The FDA said
it is still considering limits on those products, which involves a
more complicated rule-making process than prescription products.
For now, over-the-counter products will actually be permitted to
contain higher doses of the drug - up to 500 milligrams per pill or
Acetaminophen is the leading cause of liver failure in the U.S.
and sends 56,000 people to the emergency room annually. About 200
of them die, and the FDA estimates 120 of those deaths are linked
to prescription drugs with acetaminophen.
The FDA said it would add a boxed warning, the strongest type,
to all prescription drugs containing acetaminophen.
Vicodin is marketed by Abbott Laboratories, while Percocet is
marketed by Endo Pharmaceuticals. Vicodin combines acetaminophen with hydrocodone, while Percocet contains oxycodone. Both formulas also are available in cheaper generic versions. U.S. sales of all drugs in the group topped $6 billion in 2009, according to health industry data firm IMS Health.
The FDA restrictions come more than a year and a half after a
high-profile meeting where a panel of 37 expert physicians narrowly
voted to eliminate drugs like Vicodin completely.
Regulators said they decided against that action because of the
widespread use of the drugs, which were prescribed roughly 200
million times last year, according to the FDA.
"We thought this was a more reasoned and reasonable action to
take," Kweder said.
The FDA is not required to follow the panel's advice, though it
often does. The same panel recommended lowering the dose of
acetaminophen found in over-the-counter products.
(Copyright 2011 by The Associated Press. All Rights Reserved.)