Heparin News
FDA IDs Link Between Heparin Contaminant, Adverse Reactions
-FDA News
04/23/2008 -- FDA data show a “solid mechanistic link” between a heparin-like contaminant originating in China and serious adverse events and deaths, CDER Director Janet Woodcock said.
The agency has in vitro data and animal data that show the contaminant — over-sulfated chondroitin sulfate — can trigger events that would lead to adverse reactions in patients given the blood-thinning drug, Woodcock said.
Although the adverse reactions to heparin appear connected to the contaminant, some patients who received contaminated heparin did not experience them. The events seem to be related to dose size and administration method, Woodcock said. But identifying the mechanism by which the contaminant could cause the reactions “strengthens the association considerably,” she added.
The FDA issued a warning letter Monday to Changzhou SPL, a Scientific Protein Laboratories (SPL) subsidiary, citing good manufacturing practices (GMP) violations that make the firm’s active pharmaceutical ingredient adulterated.
Changzhou said the letter does not reflect its actual state of compliance withGMP or the findings of prior third-party audits of the facility. The company said it is cooperating with the FDA and will soon provide a detailed response to the warning letter.
The warning letter is available at www.fda.gov/cder/warn/2008/320-08-01.pdf.
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