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Congressmen Probe the Heparin Recall
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On the heels of a nationwide drug recall, two congressmen have asked Baxter International, Inc. to provide documentation on the manufacturing of its blood-thinning drug, heparin, as well as recent reports of serious reactions, according to a Reuters news report on Feb. 21, 2008.
The drug company has halted production of multi-dose vials of heparin and health officials are attempting to uncover the cause of four deaths and hundreds of health problems reported in patients.
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 Food and Drug Administration (FDA). The FDA is recommending that physicians, dialysis center staff and health care providers use an alternate source of heparin or another blood-thinning drug when possible.
The Agency has admitted it never inspected a Chinese plant that supplies an active ingredient for Baxter's heparin before approving it.
According to the Reuters article, Reps. John Dingell and Bart Stupak have written a letter to Baxter Chief Executive Robert Parkinson, asking whether the firm was misled by FDA into believing that the Chinese firm was an approved supplier of an active ingredient for heparin. The letter asks Baxter to provide records relating to suppliers of active ingredients for heparin.
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see also:
Heparin Laboratories
Scientific Protein Laboratories Responds to Alarm Over Tainted HeparinThe response of Scientific Protein Laboratories regarding Heparin
Heparin Warning
New York Times Reports on Heparin Warning and China LinkChinese Link in Latest Heparin Warnings. Get a Free Legal Review
FDA Health Advisory
FDA Issues Advisory on Heparin Due to Health Risks--Free Lawsuit InfoDid You Suffer Adverse Reaction After Heparin Injection? Lawsuit info
