Use Caution with Over-the-Counter Creams, Ointments
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Acne,
cough due to a cold, athlete's foot, hemorrhoids, itching from insect
bites, and minor aches and pains of muscles and joints—these are among
the conditions that people treat by applying over-the-counter (OTC)
creams and ointments to their skin. The Food and Drug Administration
(FDA) urges consumers to keep safety in mind when using such treatments.
"These
products are medicines," says Andrea Leonard-Segal, M.D., Director of
FDA's Division of Nonprescription Clinical Evaluation in the agency's
Center for Drug Evaluation and Research. "Just because they are not in
pill form and do not require a doctor's prescription, does not mean
that they cannot cause harm if they're overused or misused."
Dr.
Segal says that consumers should carefully read and follow the
directions for all OTC products, including topical ones. Topical
products are those that are applied to certain areas of the skin.
"The
medication in creams and ointments can sometimes penetrate the skin and
enter the blood stream," she says. "It is important to be aware that
the medicines in these topical products may cause problems if they are
not used as directed." Segal adds, "Sometimes the ingredients in these
products can even interact with other medicines you are taking."
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Methyl Salicylate
Many
athletes use muscle ache creams that contain methyl salicylate. Also
known as oil of wintergreen, methyl salicylate is an aspirin-type
ingredient of many topical creams that relieves pain. Used correctly,
creams containing methyl salicylate can provide temporary relief from
minor aches and pains of muscles and joints associated with simple
backache, arthritis, strains, bruises and sprains.
As with all medications, misuse of these products can cause harm.
Segal
warns that products with methyl salicylate should not be used for more
than seven days and should not be applied to wounds or damaged skin.
They should not be used under a tight bandage, and contact with eyes
should be avoided.
FDA requires the labeling of any
drug containing more than 5% methyl salicylate to include warnings that
cover such precautions as keeping the product out of children's reach
and using the product as directed.
"Always remember to
read the Drug Facts Label and any information that is provided inside
the package of an over-the-counter product," says Segal. "Keep the
labeling so you can refer back to it at a future time. The information
provided with the medication tells how to use it properly and what to
do if a problem occurs while you are using it."
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Compounded Creams
FDA is also concerned about some compounded products offered as creams and ointments.
Traditional
pharmacy compounding is a practice in which pharmacists combine, mix,
or alter ingredients to create unique medications to meet specific
medical needs of individual patients in accordance with prescriptions
issued by patients' doctors.
Compounded drugs are not
reviewed by FDA for safety and effectiveness, and are not FDA-approved.
They can expose patients to unnecessary risks when they are used
without proper medical supervision.
FDA normally
permits traditional pharmacy compounding. By contrast, some pharmacies
behave like drug manufacturers, not traditional compounding pharmacies,
because they produce standardized versions of products for general
distribution.
In December 2006, FDA warned five firms
to stop compounding and distributing topical anesthetic creams that
were being marketed for general distribution rather than responding to
the unique medical needs of individual patients.
Compounded
topical anesthetic creams are often used to lessen pain in procedures
such as laser hair removal, tattoos, and skin treatments. They are
sometimes dispensed by clinics and spas that provide these procedures,
or by pharmacies and doctors' offices.
The compounded
topical anesthetics that FDA warned about contain high doses of local
anesthetics, including lidocaine, tetracaine, benzocaine, and
prilocaine. FDA has warned that when different anesthetics are combined
into one product, each anesthetic's potential for harm is increased.
This
potential harm may also increase if the product is left on the body for
long periods of time or applied to broad areas of the body,
particularly if an area is then covered by a bandage, plastic, or other
dressing.
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For more information
FDA Warns Five Firms to Stop Compounding Topical Anesthetic Creams
www.fda.gov/bbs/topics/NEWS/2006/NEW01516.html
Sports Cream Overdose
(Medicine Plus, U.S. Library of Medicine/National Institutes of Health)
www.nlm.nih.gov/medlineplus/ency/article/002583.htm
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Date Posted: April 1, 2008
