Manufacture of Heparin Halted Due to Serious Allergic Reactions in Patients
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The
U.S. Food and Drug Administration has announced that Baxter Healthcare Corporation has
temporarily stopped manufacturing the injectable blood-thinner drug heparin due to
reports of serious allergic
reactions and low blood pressure in patients who receive high doses of the
drug.
According to an FDA spokesperson, confusion over two Chinese factories with
similar names led to a failure to inspect a plant that makes an ingredient
linked to life-threatening side
effects with the blood-thinning drug.
Reportedly, FDA regulators
mistakenly referred to inspection records for a plant from a different company
and cleared the heparin facility without necessary inspections.
Serious
reactions to the drug have included difficulty breathing, nausea, vomiting,
excessive sweating, and rapidly falling blood pressure that can lead to
life-threatening shock. Four people have died after receiving heparin.
About 350 adverse events associated with the Baxter product have been
reported since the end of last year compared to less than 100 reports in 2007,
according to the Agency.
The FDA
recommends that physicians, dialysis center staff and health care providers use
an alternate source of heparin or another blood-thinning drug when possible.
If you were harmed after being administered heparin, please complete the
form below and a representative of our firm will contact you as
soon as possible.
see also:
FDA Health Advisory
FDA Issues Advisory on Heparin Due to Health Risks--Free Lawsuit InfoDid You Suffer Adverse Reaction After Heparin Injection? Lawsuit info
Heparin Lawyers
Hundreds ill from heparin - Our lawyers will review your case, freeHeparin lawyers here for those affected by FDA inspection failure
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