BMJ  2008;336:412-413 (23 February), doi:10.1136/bmj.39496.419248.DB

News

Four deaths and 350 adverse events lead to US recall of heparin

Janice Hopkins Tanne

1 New York

The first 150 words of the full text of this article appear below.

Baxter Healthcare Corporation, which provides half the supply of heparin in the United States, recalled multidose vials of heparin sodium last month after four deaths and 350 reports of adverse events, 40% of which were serious.

More than one million multidose vials are sold each month in the US, and half of them are produced by Baxter, the US Food and Drug Administration said. The source of the heparin, which is made from pig intestines, was imported from China. The FDA said it had not inspected the Chinese plant that produced it.

The initial recall of heparin last month involved nine lots of multidose vials. Since then, Baxter has received reports of adverse reactions with other lots, the company said. Baxter and the FDA are investigating the problem.

A report in the New York Times said that a manufacturing facility in China, Changzhou SPL, which produced the ingredient for heparin, . . . [Full text of this article]


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