Published:
U.S. Pharmacopeia Aiding FDA in Improved Tests for Heparin Contamination
ROCKVILLE, Md., April 14 /PRNewswire/ -- The United States Pharmacopeial
(USP) Convention announces that it is working with the Food and Drug
Administration (FDA) to develop more sensitive methods for detecting
contaminants recently found in the widely used blood-thinning drug heparin.
This contamination is suspected of causing severe allergic reactions in some
patients and has resulted in over 60 deaths. The suspected contaminant,
over-sulfated chondroitin, is derived from the dietary supplement chondroitin.
The chemically-induced over-sulfated form can mimic blood-thinning properties.
Consequently, heparin adulterated in this manner may pass existing quality
tests. It is likely (but still being determined) that any deliberate
adulteration was done for economic reasons, because over-sulfated chondroitin
is a much less expensive ingredient than genuine heparin.
USP publishes official quality standards for medicines inthe United
States Pharmacopeia-National Formulary (USP-NF) and has worked with FDA for
over 100 years in a unique public-private partnership that helps assure the
quality of medicines inthe United States. Following a recall in January of
suspect heparin products, FDA in March asked USP to assist in re-assessing
current tests and possibly developing new methods for detecting over-sulfated
chondroitin in the heparin drug substance before it is made into a final
product. This work is ongoing and will result in updated heparin monographs.
Heparin has been sold inthe United States since the 1940s and has had a USP
monograph since 1950, which has been updated several times.
According to Roger L. Williams, M.D., USP's chief executive officer, "It
is difficult for analytical procedures to detect and identify all adulterants.
USP monographs are designed to test for known impurities that result from
manufacture or degradation, not for unknown contaminants that may be added
either accidentally or deliberately. USP will continue to work closely with
FDA and other partners to develop the most effective approaches to assure the
safety of heparin."
The availability of a good public monograph in the USP with allied
reference materials is one of a series of safety nets that work to assure that
U.S. patients and practitioners have access to good quality medicines. Other
safety nets include dedicated and trusted drug ingredient and product
manufacturers who follow good manufacturing practices (GMPs) and sound
sampling protocols in support of batch release testing. Oversight from FDA is
also key in assuring product quality along complicated and at times lengthy
supply and distribution pathways.
USP will provide further information as its work evolves. For updates on
the availability of this information, please contact Laura Provan at
lnp@usp.org or 301-816-8268.
USP -- Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a private, non-profit,
standards-setting organization that advances public health by helping to
ensure the quality and consistency of medicines, food ingredients, and dietary
supplements, promoting the safe and proper use of medications, and verifying
ingredients in drugs and dietary supplements. Its standards, which are
recognized worldwide, are developed by a unique process of public involvement
through the contributions of volunteers representing pharmacy, medicine, and
other health care professions, as well as science, academia, government, the
pharmaceutical and food industries, and consumer organizations. For more
information about USP and its public health programs, visit
www.usp.org/newscenter.
SOURCE U.S. Pharmacopeia
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