US Halts Heparin Blood-thinner Imports

by Dr. Sunil Shroff on  March 15, 2008 at 11:36 AM Drug News   - G J E 4
US authorities decided to put a stop to all the imported blood-thinners. The maufacturers were alerted to test the products against contaminants that may cause serious diseases.
US Halts  Heparin Blood-thinner Imports
US Halts Heparin Blood-thinner Imports

"This alert tells investigators to pay special attention to all heparin products headed for entry in the US," said Janet Woodcock, director of the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research.

"They would be stopping all heparin products for import and ensuring that manufacturers are testing them or we will be testing them ourselves," she said in a telephone press conference.

The FDA on March 5 said it had detected an unidentified contaminant in heparin injections sold by Baxter International pharmaceuticals.

It was determined that most of the active ingredients in the drug came from a plant in Changzou, China working with Wisconsin-based Scientific Protein Laboratories, which supplies Baxter, Woodcock said.

On February 11, the FDA announced a limited recall of Baxter's multi-dose heparin, and on February 28 the lab expanded the recall to include nearly all injectable heparin being produced.

Although the Chinese plant agreed not to export their heparin products to the United States, the FDA issued the alert to "detain all heparin products they might ship in the future," Woodcock said.

She also said the FDA received commitments from five other top manufacturers of injectable heparin "to test their active pharmaceutical ingredient for potential contamination" using two sophisticated, FDA-recommended tests.

Without identifying them, Woodcock said the five companies "represent a substantial part of the overall heparin market," and their test results and reports "will really improve our safety net."

She said any company refusing to test would trigger an FDA block of their imported heparin products at the border.

Woodcock said the FDA was also working with health authorities in Germany and Japan, where pharmaceuticals have recalled apparently contaminated heparin products linked to allergic reactions.

The FDA has not proven the contaminants are the cause of death, severe respiratory allergic reactions or lower blood pressure in patients.

Since November 2007, however, it has received reports of severe allergic reactions after a single Baxter heparin injection.

The FDA has received 785 complaints of health problems as well as 46 reports of death, but Woodcock said the initial determination linking 19 of those deaths to the Baxter drug was not certain.

In the past week, she said, there have been no reports of deaths and only two of allergic reactions from the product.

APP Pharmaceuticals Inc, another top US heparin manufacturer, has boosted production to prevent a shortage of the blood-thinner in the United States.

APP heparin tested so far is contaminant-free, FDA said.

Source: AFP

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