A Painkiller Reminder
FDA Label Proposal Reinforces Advice to Proceed With Caution on
Over-the-Counter Medicines

By January W. Payne
Washington Post Staff Writer
Tuesday, January 2, 2007; Page HE01

A recent Food and Drug Administration proposal to add stronger warning
labels to several popular types of over-the-counter painkillers, noting they
pose a risk of liver and stomach damage, shouldn't scare most consumers into
avoiding the products entirely, experts say. But the news should remind
patients to take the lowest dose needed for the shortest possible time and
to be aware of the ingredients contained in all of their medications,
particularly when taking more than one medicine.

Under the FDA's proposal, warnings would be added to the labels of all OTC
medicines containing acetaminophen and nonsteroidal anti-inflammatory drugs
(NSAIDs), including aspirin, naproxen and ibuprofen, which are used to treat
headaches, pain, fever, menstrual cramps and muscle aches. Affected products
include such popular brands as Tylenol, Aleve, Motrin and Advil. The
warnings would "include important safety information regarding the potential
for stomach bleeding and liver damage and when to consult a doctor," the FDA
reports in a written statement.

For most people, over-the-counter pain relievers taken occasionally in
recommended doses pose few risks. (By Pat Sullivan -- Associated Press)

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"In general, I think occasional use is safe," except in high-risk patients,
said Jack A. Di Palma, immediate past president of the American College of
Gastroenterology. High-risk patients include people older than 60, those
taking the medications for longer than directed, patients taking blood
thinners or more than one medication containing an NSAID and patients who
have experienced ulcers or stomach bleeding.

Gastroenterologists have been discouraging the use of NSAIDs for patients in
these groups for years, he said. When such patients disregard this advice,
Di Palma said, "we've suggested trying to do things to limit injury," such
as taking proton pump inhibitors (stomach-protecting medications) to protect
the gastrointestinal tract. For most other patients, he says, risks are
minimal.

Doctors have known for years that NSAIDs can cause kidney damage and
gastrointestinal bleeding in some patients, even when taken at recommended
dosages. They've also known acetaminophen can cause severe liver damage when
taken at higher than recommended doses or in combination with three or more
alcoholic drinks per day. The FDA has defended the pace of agency action,
citing regulatory procedures. But Public Citizen, a Washington-based
consumer advocacy group, said the FDA's proposal comes "decades late"; the
group wants the agency to require warnings in painkiller ads and make public
service announcements about the change.

The FDA also is considering whether to impose limits on the number of
acetaminophen tablets sold per bottle; such limits exist in Britain, where
acetaminophen overdose is a leading cause of suicide.

About 56,000 Americans visit emergency rooms each year because of
acetaminophen poisoning, according to the FDA; about 100 people die annually
because of unintentional overdoses. More than 200,000 Americans go to the
hospital each year because of NSAID reactions; an estimated 16,000 die.

It's expected to be a year before stronger labels appear on OTC medication
bottles. In the meantime, suggests Edward Langston, chair-elect of the board
of trustees for the American Medical Association, consumers should ask
themselves these questions before taking any OTC medications: "How much of
the OTC medicine can [I] take and for how long? And what can I take
together?"

For non-chronic conditions, it's almost always best to take medications for
as short a period as possible, and to avoid or limit taking medicines
together, he said.

If you're unsure of the answers, Langston said, "the most handy -- and
underutilized -- source of information is to talk to your pharmacist."
Alternately, call your doctor, he suggested.

It's also important to know which ingredients are contained in your
prescription medications: Some prescribed drugs, such as Ultracet,
Darvocet-N and ketoprofen (all used for pain relief), contain NSAIDs or
acetaminophen.

Many OTC cold and arthritis medicines, such as Advil Cold & Sinus, NyQuil
and Tylenol Arthritis Pain, also contain NSAIDs or acetaminophen, making it
risky for patients to combine them with nonprescription pills they may be
taking for a headache, fever or pain.

Under the proposed changes, all affected products would bear labels
containing beefed-up warnings about interactions with alcohol and
prominently displaying the product's main ingredient. Some drug
manufacturers have voluntarily added stronger safety warnings in the past
few years.

Among the FDA's proposed changes:

· NSAIDs would carry added warnings that they pose a risk for stomach
bleeding in people older than 60, in those taking the medications for longer
than directed, in patients taking blood thinners or more than one medication
containing an NSAID and in patients who've experienced ulcers or stomach
bleeding.

· NSAIDs and acetaminophen would bear warnings against taking them with even
moderate amounts of alcohol -- three or more drinks per day.

· Acetaminophen, best known under the brand name Tylenol, would get warnings
advising consumers of the possibility of liver toxicity -- especially when
taken in high doses or with other acetaminophen- containing products.

Wire services contributed to this report.
http://www.washingt onpost.com/ wp-dyn/content/ article/2006/ 12/29/AR20061229
01731.html? referrer= email


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