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:
Baxter Laboratories
The relationship between Baxter and Scientific Protein LaboratoriesScientific Protein Laboratories is Baxter's main supplier
Heparin & Allergic Reactions
Contaminant in Supply Found to Cause Heparin Allergic ReactionsAllergic Reactions Due to Contaminant In Heparin Supply--Lawsuit info
Heparin Recall Sparks Inquiry
Congressmen: How did it happen? Probe into Heparin Recall GrowsFind out how the Heparin recall sparks congressional inquiry
