Pain Relievers Use Caution
Jan. 23, 2004: The Food and Drug Administration (FDA) has launched a national
education campaign to provide advice on the safe use of over-the-counter (OTC)
pain relief products. FDA's campaign focuses on the OTC pain and fever reducers
that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs),
which include products such as aspirin, ibuprofen, naproxen sodium and
ketoprofen.
Our Comments: We applaud the FDA for its educational campaign on the
safe use of OTC products for pain. But will it help?
We are looking at a large bottle of acetaminophen. It is Tylenol. The name is
in large letters on the label. The warnings on the label are in print at most
one-sixth that size. We cannot read the warnings without our glasses and, even
with them, the warnings are not easy or inviting to read. How many people have
read the label? Have you?
Some years ago, one of us became anemic. The culprit was ibuprofen, which was
causing low-grade bleeding from the gastrointestinal tract. For arthritis we had
been taking a couple of Advil tablets up to three times a day (within the limits
on the label). What was NOT on the label what the fact that Advil can cause
stomach bleeding, particularly in senior citizens.
The FDA Commissioner Mark B. McClellan says: "We want to remind
consumers who take these products that it's important to follow current dosing
and label directions carefully."
Then, why doesn't the FDA require the warnings on the label of OTC pain
products to be legible? And why doesn't the FDA require the labels to contain
the key cautions?
We would submit that OTC pain products like Tylenol and Advil are very useful
but they can be, and often prove, to be unsafe. The FDA and the makers of these
products can help make them safer.
Barbara K. Hecht,
Ph.D.
Frederick Hecht, M.D.
Medical Editors, MedicineNet.com
Related Links
FDA Launches Consumer Campaign on Safe Use of OTC Pain Products
The Food and Drug Administration (FDA) today launched a national education
campaign to provide advice on the safe use of over-the-counter (OTC) pain relief
products.
"Pain relievers and fever reducers are safe drugs when used as directed,
but they can cause serious problems when used by people with certain conditions
or those who are taking specific medicines," said FDA Commissioner Mark B.
McClellan, M.D., Ph.D. "We want to remind consumers who take these products
that it's important to follow current dosing and label directions
carefully."
FDA's nationwide campaign focuses on the OTC pain and fever reducers that
contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), which
include products such as aspirin, ibuprofen, naproxen sodium and ketoprofen.
"'Read labels carefully, be sure you are getting the proper dose, and
check with your doctor or pharmacist to be sure that you can use these drugs
safely," said Dr. McClellan.
Many OTC medicines sold for different uses have the same active ingredient.
For example, a cold-and-cough remedy may have the same active ingredient as a
headache remedy or a prescription pain-reliever. To minimize the risks of an
accidental overdose, consumers should avoid taking multiple medications that
contain the same active ingredient at the same time.
Acetaminophen is an active ingredient found in more than 600 OTC and
prescription medicines, such as pain relievers, cough suppressants and cold
medications. It is safe and effective when used correctly, but taking too much
can lead to liver damage, and even death. The risk for liver damage may be
increased in consumers who drink three or more alcoholic beverages per day while
using acetaminophen-containing medicines.
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