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Published on 21 February 2008

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FDA admits mistake in Heparin probe

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Officials in the US investigated the wrong factory when they assessed the safety of a Chinese-made ingredient that may be a source of problems with the anticoagulant heparin, it has emerged.

The drug, which is manufactured by Baxter International, has been linked to four deaths and hundreds of reports of allergic reactions.

But Joseph Famulare, deputy director of the Center for Drug Evaluation and Research’s compliance department, said the Chinese manufacturer responsible for the compound was not inspected due to a mix up with a firm with a similar name.

The Food and Drug Administration (FDA) realised the mistake in the last month, and believes it is an isolated incident.

Investigators are now travelling to China to inspect the correct company that manufactures the drug’s active ingredient.

The team includes a chemist fluent in Chinese and an expert in drug manufacturing technology.

Mr Famulare said: “We’ve given this team the flexibility to extend this inspection as long as it takes as well as investigate the appropriate leads within China.”

Inspections are also being conducted at a Baxter facility in New Jersey and at the supplier Scientific Protein Laboratories in Wisconsin.

The FDA told doctors last week to stop using heparin after receiving 350 reports of side effects already this year.

Copyright © PA Business 2008

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