FDA calls for pain reliever warning

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http://www.usatoday.com/money/industries/health/2006-12-19-fda-warning_x.htm

By Schmit and Appleby, USA TODAY

Non-prescription pain relievers used by millions of U.S. consumers need

stronger health warnings regarding liver or stomach risk, the Food and Drug

Administration said Tuesday.

The drugs include some of the most commonly taken in the USA — aspirin,

ibuprofen and acetaminophen — and will affect such household brands as Motrin,

Advil, Aleve and Tylenol.

While some manufacturers already note the health risks on packages, the FDA

wants the warnings to be more specific, standardized and prominent. New labels

aren't likely to be required for at least a year, but companies can do so

sooner.

The FDA proposes that:

•Products with acetaminophen, such as Tylenol, include warnings for liver

toxicity, particularly when used in high doses, with other acetaminophen

products or with three or more drinks of alcohol a day.

•Over-the-counter NSAIDs (short for non-steroidal anti-inflammatory drugs)

include warnings for stomach bleeding in people over 60; those who have had

ulcers, take a blood thinner or more than one NSAID; or those who take them with

alcohol or longer than directed.

Attention focused on their risks in 2004 when prescription NSAID Vioxx was

withdrawn because of heart attack and stroke risk. Last year, the FDA sought a

warning on prescription NSAID Celebrex for cardiovascular and stomach risks. An

FDA advisory panel in 2002 said over-the-counter NSAIDs should have stronger

warnings about stomach bleeding.

To help consumers track their consumption, the FDA also wants " acetaminophen "

or " NSAID " to be prominent on the package. Consumers taking a pain reliever may

not know that a cold medication, for example, also contains the ingredient.

Because over-the-counter NSAIDs are usually taken at lower doses and for less

time than prescription NSAIDs, their cardiovascular risk is low, says the FDA's

Ganley, head of non-prescription drugs.

The warnings don't stem from new data regarding health risks and NSAIDs, Ganley

says. But he added there may be increasing evidence of liver risks with

acetaminophen. A study published last year in Hepatology concluded that liver

damage caused by acetaminophen exceeded other causes of U.S. drug-induced acute

liver failure, but that most of the cases stemmed from accidental overdoses or

suicide attempts. About 100 people in the USA die each year after accidental

acetaminophen overdoses, the FDA says.

Hardin of the Arthritis Foundation says the new warnings should be done

sooner rather than later.

" I can't see any downside to anyone by adding this to the labeling, " he says.