This only applies to the companies below that are marketing
standardized creams. Individuals compounding should have no problems
continuing to compound.
FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams
The Food and Drug Administration (FDA) is warning five firms, Triangle
Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy,
Hal’s Compounding Pharmacy, and New England Compounding Center,
to stop compounding and distributing standardized versions of topical
anesthetic creams, which are marketed for general distribution rather
than responding to the unique medical needs of individual patients.
Firms that do not resolve violations in FDA warning letters risk
enforcement such as injunctions against continuing violations and
seizure of illegal products.
FDA is concerned about the serious public health risks related to
compounded topical anesthetic creams. Exposure to high concentrations of
local anesthetics, like those in compounded topical anesthetic creams,
can cause grave reactions including seizures and irregular heartbeats.
Two deaths have been connected to compounded topical anesthetic creams
made by Triangle Compounding Pharmacy and University Pharmacy, two of
the five pharmacies receiving warning letters. Similar topical
anesthetic creams are compounded by the other firms, and today’s
action serves as a general warning to firms that produce standardized
versions of these creams.
"Compounded topical anesthetic creams, like all compounded drugs, are
not reviewed by FDA for safety and effectiveness, and are not
FDA-approved. These highâ€'potency drugs may expose patients to
unnecessary risk, especially when they are used without proper medical
supervision,†said Dr. Steven Galson, Director of FDA's Center
for Drug Evaluation and Research. FDA is advising consumers who have
questions or concerns about compounded topical anesthetic creams to
contact their health care providers.
Compounded topical anesthetic creams are often used to lessen pain in
procedures such as laser hair removal, tattoos, and skin treatments.
They may be dispensed by clinics and spas that provide these procedures,
or by pharmacies and doctors’ offices.
These creams contain high doses of local anesthetics including
lidocaine, tetracaine, benzocaine, and prilocaine. 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.
The risk of harm is even greater in small children, patients with
pre-existing heart disease, and patients with severe liver disease.
FDA-approved topical anesthetic products are commercially available and
properly labeled, and are regularly used in health-care settings.
However, some pharmacies create their own standardized versions of these
products, often including combinations of ingredients and ingredients at
higher strengths than found in FDA-approved products, and often lacking
appropriate warnings or directions for use.
The five firms warned by FDA have stated that they produce their topical
anesthetic creams as part of the practice of pharmacy compounding.
Traditional pharmacy compounding typically involves pharmacies preparing
drugs that are not commercially available, such as a unique medicine for
a patient who is allergic to an ingredient in a FDAâ€'approved drug.
This kind of compounding follows a physician’s decision that his
or her patient has a special medical need that cannot be met by
FDAâ€'approved drugs.
FDA normally permits such traditional pharmacy compounding and the
agency’s action is not targeting this practice. By contrast, FDA
is concerned that the five firms receiving warning letters are behaving
like drug manufacturers, not traditional compounding pharmacies, because
they produce standardized versions of topical anesthetic creams for
general distribution.
Consumers and health care professionals should notify FDA of any
complaints or problems associated with compounded drugs, including
compounded topical anesthetic products. These reports may be made to
MedWatch, FDA’s voluntary reporting program, by phone at
1-800-FDA-1088, or online at www.fda.gov/
Warning Letter to Triangle Compounding Pharmacy (Cary, NC)
http://www.fda.
Warning Letter to University Pharmacy (Salt Lake City, UT)
http://www.fda.
Warning Letter to Custom Scripts Pharmacy (Tampa, FL)
http://www.fda.
Warning Letter to Hal’s Compounding Pharmacy, Inc. (San Diego,
CA) http://www.fda.
Warning Letter to New England Compounding Center (Framingham, MA)
http://www.fda.
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