2nd UPDATE: FDA Panel For Eliminating Some Acetaminophen Products
30 Juin 2009 - 10:20PM
Dow Jones News
Prescriptions drug products that include a key pain-relieving
ingredient - acetaminophen - should be eliminated from the market,
a panel of medical experts told the U.S. Food and Drug
Administration Tuesday.
The recommendation has the potential to affect a host of
currently approved prescription products, including Abbott
Laboratories (ABT) Vicodin, Johnson & Johnson's (JNJ) Ultracet
and Endo Pharmaceuticals Holdings Inc.'s (ENDP) Percocet. The
recommendation could also affect hundreds of pending drug
applications.
Twenty panel members voted in favor of eliminating prescription
products that contain acetaminophen with other ingredients while 17
voted against. The FDA doesn't have to follow the panel's advice
but generally does. The panel made the recommendation because
acetaminophen has been linked to liver damage and death.
The recommendation, if implemented, would affect more than 240
pending new drug applications, according to the FDA. Painkillers
that combine acetaminophen with hydrocodone, a powerful
pain-killing ingredient, are the most commonly prescribed drugs in
the U.S., the FDA said. There are currently no hydrocodone products
that don't include acetaminophen.
Acetaminophen is an ingredient found in over-the-counter
painkillers such as Excedrin and Tylenol and a host of cough
medicines like NyQuil and Theraflu. The panel voted against pulling
over-the-counter products that combine acetaminophen with other
ingredients, citing data showing liver damage is most frequent in
prescription products that include acetaminophen.
The panel also voted 21 to 16 to recommend the maximum daily
dose of acetaminophen available in over-the-counter drugs be
lowered. The panel recommended the maximum daily dose be lowered to
2,600 milligrams from 4,000 milligrams.
The panel also recommended that 500-milligram doses of the drug
be available by prescription only.
The panel said it was against limiting the quantity of
acetaminophen that can be sold in a package. The drug is available
in 1,000 pill bottles in certain discount stores such as Costco
Wholesale Corp.'s (COST) stores. Some panel members said they were
concerned large bottles encouraged people to take too much of the
drug.
"I think we have to send a message that there is a problem with
this medication," said panel member Winifred A. Landis, a
pharmacist from Indiana. She said the FDA should consider what size
packages for Tylenol and other acetaminophen products should be
sold in non-pharmacy settings.
About 100 people die annually from accidentally overdosing on
acetaminophen. The FDA says the drug is safe if taken at
recommended levels. However, the drug's prevalence in a variety of
pain relievers, fever reducers and cough medicines means patients
don't realize they are taking several drugs that contain the same
ingredient, often leading to an overdose of acetaminophen.
The panel will vote on a series of other options that will
potentially limit access to products containing acetaminophen. One
of the most important questions, expected to be voted on at the end
of the meeting, is whether to eliminate medicines that combine
acetaminophen with other ingredients.
This could have implications for a host of products, including
Johnson & Johnson (JNJ)'s combination painkiller, Ultracet.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com