Generic Drug Co Recalls Acetaminophen To Avoid Dose Confusion
15 Juillet 2009 - 11:20PM
Dow Jones News
A generic pharmaceutical company based in Georgia is recalling
concentrated drops of acetaminophen, a key ingredient in Tylenol,
to help patients avoid accidentally overdosing on the product, the
U.S. Food and Drug Administration said Wednesday.
Acetaminophen, a drug in Tylenol and a host of cough medicines
and painkillers, is under intense scrutiny by the FDA because
high-doses of the medicine are the leading cause of liver
damage.
The FDA said Brookstone Pharmaceuticals LLC has voluntarily
begun recalling its Concentrated Acetaminophen Drops, which are
available in 16-ounce bulk containers. "The firm is recalling its
product to the consumer level as a cautionary measure to minimize
any confusion and potential risk to patients from dosing errors,"
the company said in a press release, which was posted on the FDA's
Web site Wednesday.
A Brookstone representative wasn't immediately available to
comment.
The FDA has been looking at liver-injury concerns associated
with acetaminophen for more than 30 years. At a widely publicized
FDA meeting in June, more than 30 doctors and researchers
recommended new limits on dosing for acetaminophen and asked that
the painkillers Percocet and Vicodin be pulled from the market.
Percocet, made by Endo Pharmaceuticals Holdings Inc. (ENDP), and
Abbott Laboratories' (ABT) Vicodin combine acetaminophen with other
pain-killing ingredients.
About 100 people die annually from accidentally overdosing on
acetaminophen, 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.
Often patients don't realize they are taking an over-the-counter
product and a prescription product at the same time that contain
that same ingredient.
The company's recall is tied directly to confusion about dosing
and the FDA's advisory panel meeting in June. "Brookstone has not
received any adverse events associated with this product but due to
recent advisory panel concerns, Brookstone has taken voluntary
action," the company's press release said.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com