If
you've ever had a skin reaction when taking acetaminophen, don't take
the drug again and discuss alternate pain relievers/fever reducers with
your health care professional.
Acetaminophen,
a fever and pain reliever that is one of the most widely used medicines
in the U.S., can cause rare but serious skin reactions, warns the Food
and Drug Administration (FDA).
Although rare, possible reactions
to acetaminophen include three serious skin diseases whose symptoms can
include rash, blisters and, in the worst case, widespread damage to the
surface of skin. If you are taking acetaminophen and develop a rash or
other skin reaction, stop taking the product immediately and seek
medical attention right away.
Used for decades by millions of
people, acetaminophen is the generic name of a common active ingredient
included in numerous prescription and non-prescription medicines.
Tylenol is one brand name of the pain reliever sold over the counter,
but acetaminophen is also available as a generic under various names. It
is also used in combination with other medicines, including opioids for
pain and medicines to treat colds, coughs, allergy, headaches and
trouble sleeping.
"This new information is not intended to worry
consumers or health care professionals, nor is it meant to encourage
them to choose other medications," says Sharon Hertz, M.D., deputy
director of FDA's Division of Anesthesia, Analgesia and Addiction.
"However, it is extremely important that people recognize and react
quickly to the initial symptoms of these rare but serious, side effects,
which are potentially fatal."
Other drugs used to treat fever and
pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen
and naproxen, already carry warnings about the risk of serious skin
reactions. Advil and Motrin are among the common brand names that
include ibuprofen as an active ingredient. Aleve and Midol Extended
Relief are among the best-known brand names that include naproxen as an
active ingredient.
FDA is requiring that a warning about these
skin reactions be added to the labels of all prescription medicines
containing acetaminophen. FDA will work with manufacturers to get the
warnings added to the labels of over-the-counter (OTC) medicines
containing acetaminophen.
On OTC medicines, the word
"acetaminophen" appears on the front of the package and on the Drug
Facts label's "active ingredients" section. On prescription medications,
the label may spell out the ingredient or use a shortened version such
as "APAP," "acet," "acetamin" or "acetaminoph." back to top
Ingredient Linked to Several Conditions
Stevens-Johnson
Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most
serious skin reactions linked in rare cases to acetaminophen. They
usually require hospitalization and can cause death.
Problems
usually begin with flu-like symptoms followed by rash, blistering and
extensive damage to the surfaces of the skin. Recovery can take weeks or
months, and possible complications include scarring, changes in skin
pigmentation, blindness and damage to internal organs.
A third
skin reaction, acute generalized exanthematous pustulosis (AGEP),
usually resolves within two weeks of stopping the medication that caused
the problem.
A serious skin reaction can occur at any time, even
if you've taken acetaminophen previously without a problem. There is
currently no way of predicting who might be at higher risk.
If
you've ever had a skin reaction when taking acetaminophen, don't take
the drug again and discuss alternate pain relievers/fever reducers with
your health care professional. back to top
Evidence of Link
Prior
to deciding to add a warning about skin reactions to products
containing acetaminophen, FDA reviewed medical literature and its own
database, the FDA Adverse Event Reporting System (FAERS).
A search
of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67
hospitalizations and 12 deaths. Most cases involved single-ingredient
acetaminophen products; the cases were categorized as either probable or
possible cases associated with acetaminophen.
A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.
FDA
has examined—and continues to examine—acetaminophen for safety issues,
just as it does with all approved drugs. The warning comes two years
after FDA took new steps to reduce the risk of liver injury from
acetaminophen. In that case, FDA asked all makers of prescription
products to limit acetaminophen to 325 milligrams per tablet or capsule.
FDA also required all prescription acetaminophen products to include a
Boxed Warning—FDA's strongest warning, used for calling attention to
serious risks.
The agency continues to consider the benefits of this medication to outweigh the risks.
"FDA's
actions should be viewed within the context of the millions who, over
generations, have benefited from acetaminophen," says Hertz.
"Nonetheless, given the severity of the risk, it is important for
patients and health care providers to be aware of it."