WASHINGTON (AP) - A manufacturer of the blood thinner heparin initiated a
nationwide recall Friday because some products may contain a potentially
dangerous contaminant. Contaminated heparin from a different manufacturer has
been associated with 19 deaths and hundreds of allergic reactions.
In the recall announced Friday, B. Braun Medical Inc. said it was recalling
23 lots of heparin as a precautionary measure. No adverse events have been
reported in connection with their product, company officials said in a press
release.
The company issued the recall after one of its suppliers, Wisconsin-based
Scientific Protein Laboratories, disclosed that an ingredient it provided
contained oversulfated chondroitin sulfate, a chemical that does not occur
naturally. Federal officials are investigating how the contaminant got into the
drug.
Heparin is derived from a mucus obtained from pig intestines and other
animal tissues, often processed by small, unregistered workshops in China.
Scientific Protein Laboratories owns a Chinese factory -- Changzhou SPL -- and
buys additional raw heparin from other Chinese suppliers.
Scientific Protein Laboratories also supplies Baxter International Inc.
Baxter recalled nearly all its U.S.-sold heparin injections after some patients
experienced extreme allergic reactions. The lots of heparin linked to hundreds
of allergic reactions were marketed by Baxter International and produced in
China.
There have been similar recalls of Chinese-sourced heparin in Germany and
Japan.
China's drug safety agency recently said that raw heparin suppliers have
been required to improve their management and tests on their products.
Typical symptoms of the allergic reaction to heparin include low blood
pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.
Customers in the U.S. and Canada that have received heparin from one of the
recalled product lots should discontinue use immediately
FDA officials said that recall would still allow for an adequate supply of
heparin. The heparin that Baxter recalled primarily is used in large-dose
injections just prior to surgery. While the heparin from B. Braun Medical Inc.,
is a pre-mix solution given intravenously, officials said.
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