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Senior Citizen Health & Medicine
FDA Proposes Labeling Changes to Over-the-Counter
Pain Relievers
Warnings regard potential for stomach
bleeding, liver damage
December 20, 2006 - The Food and Drug
Administration has proposed to amend the labeling regulations on
over-the-counter (OTC) Internal Analgesic, Antipyretic, and
Antirheumatic (IAAA) drug products to include important safety
information regarding the potential for stomach bleeding and liver
damage and when to consult a doctor. OTC IAAA drug products, commonly
known as acetaminophen and nonsteroidal anti-inflammatory drugs
(NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used
to treat pain, fever, headaches, and muscle aches.
(See questions and answers below news report)
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Health & Medicine |
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To help ensure safe use of OTC products, and to
provide consumers with the labeling necessary for them to make more
informed medical decisions, FDA yesterday proposed the following label
changes:
For Products Containing Acetaminophen
● To require new warnings which would highlight
the potential for liver toxicity, particularly when using acetaminophen
in high doses, when taking more than one product with acetaminophen, and
when taken with moderate amounts of alcohol;
● To require that the ingredient acetaminophen be
prominently identified on the product's principal display panel (PDP) of
the immediate container, and the outer carton (if applicable).
For Products Containing NSAIDs
● To require new warnings for products that
contain an NSAID which would highlight the potential for stomach
bleeding in persons over age 60, in persons who have had prior ulcers or
bleeding, in persons who take a blood thinner, when taking more than one
product containing an NSAID, when taken with moderate amounts of
alcohol, and when taking for longer time than directed; and
● To require that the name of the NSAID
ingredient and the term "NSAID" be prominently identified on the
product's PDP of the immediate container and the outer carton (if
applicable).
The new labeling would be required for all OTC drug
products that contain only an IAAA ingredient, as well as for products
that contain an IAAA ingredient with other ingredients, such as cold
symptom relievers. Consumers may also be taking IAAA ingredients in
their prescription medications, which makes it important to alert them
of the contents of their OTC medications, so they do not take too much
of an IAAA ingredient.
FDA based its proposal for labeling changes on
previous Advisory Committee discussions, recommendations, and public
comments (see
http://www.fda.gov/ohrms/dockets/ac/cder02.htm#NonprescriptionDrugs)
and a review of the scientific literature.
A number of manufacturers of OTC internal analgesic
drug products already have voluntarily implemented labeling changes to
identify these potential safety concerns.
Comments on the current proposal, to be published
in the December 26, 2006 Federal Register may be sent to Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: (http://www.fda.gov/ohrms/dockets/default.htm
).
Questions and Answers
Proposed rule for
Labeling Changes to Over-the-Counter Pain Relievers
1. What is the Food and Drug Administration (FDA)
announcing today?
The Food and Drug Administration (FDA) today
proposed to amend the labeling regulations to add important safety
information for over-the-counter (OTC) Internal Analgesic, Antipyretic
and Antirheumatic (IAAA) drug products. These products are used to
treat pain, fever, headaches and muscle aches.
New warnings are proposed for labeling of
nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin,
ibuprofen, naproxen and ketoprofen, regarding the potential for stomach
bleeding. New warnings are proposed for labeling of acetaminophen about
potential liver damage and when to consult a doctor.
2. What labeling changes is FDA proposing?
For Products Containing NSAIDs
● To require that the name of the NSAID
ingredient and the term NSAID be prominently identified on the
products principal display panel (PDP) of the immediate container and
the outer carton (if applicable).
● To require new warnings which would highlight
the potential for stomach bleeding in people who use certain other
medications or are otherwise at high risk for stomach problems.
For Products Containing Acetaminophen
● To require that the ingredient acetaminophen be
prominently identified on the products principal display panel (PDP) of
the immediate container, and the outer carton (if applicable).
● To require new warnings which would highlight
the potential for liver toxicity and to warn consumers against using
more than the recommended dose of acetaminophen; using more than one
product (over-the-counter or prescription) containing with
acetaminophen, and taking acetaminophen with moderate amounts of
alcohol.
3. What products would this proposed rule affect?
The new labeling would be required for all OTC drug
products that contain only an IAAA ingredient or acetaminophen, as well
as products that contain an IAAA ingredient or acetaminophen with other
ingredients, such as cold symptom relievers. This proposed rule is
applicable only to OTC drug products and not to prescription products
that IAAA ingredients or acetaminophen. Consumers may also be taking
IAAA ingredients or acetaminophen in their prescription medications, so
it is important that they know the contents of both their prescription
and OTC medications.
4. What other topics is FDA asking for comments
about?
FDA is continuing to collect information to make
decisions about other aspects of IAAA and acetaminophen use. For
acetaminophen products, FDA would like to better understand whether
there are any people, other than those discussed in the proposed
labeling, who should not take the recommended dose of acetaminophen.
FDA would also like information about other measures, such as limiting
the number of tablets in a package.
5. Are IAAA products and acetaminophen products
safe to use?
IAAA and acetaminophen drug products have been
available for many years without a prescription. These products are safe
and effective when properly used by consumers. The FDA believes that
consumers need to know that these products can cause serious side
effects when used improperly. FDA urges people to read the labels of all
the OTC medicines they take to know how to take them properly.
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