NEWS - FDA seeks less acetaminophen in prescription drugs

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FDA seeks less acetaminophen in prescription drugs

By Heavey

WASHINGTON, Jan 13 (Reuters) - U.S. health regulators want to limit

the amount of acetaminophen in prescription pain medicines in an

effort to curb the risk of liver damage.

The move announced on Thursday aims to limit combination drugs such as

the opioids Percocet and Vicodin to 325 milligrams of acetaminophen

per pill and calls for them to carry a " black box " warning about

potential liver failure.

Some of these medicines now contain as much as 750 milligrams of

acetaminophen, a drug also sold over the counter in lower doses as a

generic painkiller and & 's (JNJ.N) Tylenol.

" Patients taking these prescription products often do not know they

are taking acetaminophen at all, " said Kweder, a deputy

director at FDA's Center for Drug Evaluation and Research. " They don't

realize that they're overdosing. "

The move affects products made by & , Abbott

Laboratories (ABT.N), Endo Pharmaceuticals Holding Inc (ENDP.O),

Pharmaceuticals Incorporated (WPI.N) and Boehringer Ingelheim's

Roxane Laboratories unit, among others.

FDA said it was asking affected companies to comply but stopped short

of ordering the actions. Changes would be phased in over three years.

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Read the full article here:

http://www.reuters.com/article/idUSN1328805720110113

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