3rd UPDATE: FDA Panel For Eliminating Some Acetaminophen Products
2009年7月1日 - 8:00AM
Dow Jones News
Medical experts on Tuesday recommended new limits on a key
ingredient in Tylenol and a host of cough medicines and painkillers
that could alter how patients treat common colds, headaches and
severe pain.
More than 30 doctors, pharmacists and researchers recommended a
range of options to help reduce liver injury associated with
acetaminophen, a pain reliever and the most commonly prescribed
drug in the U.S. The options, which range from putting liver injury
warnings on drug labels to pulling medicines off the market, would
have sweeping effects for companies, doctors and patients if
implemented.
"Whatever we do on any of these options, it will really affect
the whole health care system," said Gerald Dal Pan, director of the
FDA's office of drug surveillance.
The committee of experts recommended the FDA lower dosing levels
of acetaminophen, saying large doses makes it easy for patients to
accidentally overdose and suffer either liver injury or death. The
panel also suggested that large doses of Tylenol be available by
prescription only. Those changes would make it harder for some
patients, particularly the elderly and others who suffer from
chronic pain, to get Tylenol.
The recommendation to pull certain prescription drug products
containing acetaminophen from the market would 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 more than 240 drug applications
that are currently under FDA review.
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 the drug.
About 100 people die annually from accidentally overdosing on
the drug, though the FDA says it is safe if taken at recommended
levels. Part of the problem with dealing with liver injuries
associated with acetaminophen is the drug's prevalence, the FDA and
panel members said. Often patients don't realize they are taking an
over-the-counter product and a prescription product at the same
time that contain the ingredient.
While the panel didn't always favor one recommendation over
another, two proposals were well received. Thirty six of 37 panel
members said prescription drug products containing acetaminophen
should include strong warnings about the drug's potential to cause
liver injury.
The same split of panel members said only one concentration of
over-the-counter cold medicines should be available, citing
concerns about liver damage in children. Products such as Theraflu
and Nyquil could be affected by such a proposal.
Over-the-counter cold medicines have been under attack in the
last 10 years, usually in connection with decongestants containing
chemicals that were linked to strokes in women and children.
Drug makers changed their decongestant ingredients, and in 2007,
manufacturers voluntarily withdrew cough and cold medicines aimed
at kids under two years old. Then last year, the FDA, under
pressure from consumer advocates and pediatricians, recommended
that children under six not be given over the counter cold and
cough medicines. The leader of the movement to limit cold-medicine
usage in children was then-Baltimore City health director Joshua
Sharfstein. He is now deputy commissioner of the FDA.
-Alicia Mundy contributed to this report.
-By Jared A. Favole, Dow Jones Newswires; 202-862-9207;
jared.favole@dowjones.com