FDA News
FOR IMMEDIATE RELEASEFebruary 11, 2008
Media Inquiries: Karen Riley, 301-827-6244Consumer Inquiries: 888-INFO-FDA
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic ReactionsFDA advises health care practitioners to switch suppliers and limit use of drug until problem identified
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.
Essa é explicação nessa quarta-feira à noiteFOR IMMEDIATE RELEASEFebruary 11, 2008
Media Inquiries: Karen Riley, 301-827-6244Consumer Inquiries: 888-INFO-FDA
Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic ReactionsFDA advises health care practitioners to switch suppliers and limit use of drug until problem identified
The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.
Feb. 13, 2008 The U.S. Food and Drug Administration said it never inspected a Chinese facility that made the active ingredient of a Baxter International blood-thinner that is now under investigation. The blood-thinner probe started after reports of hundreds of allergic reactions and four deaths among its users.An FDA spokeswoman said the plant making the active ingredient for the drug heparin "was supposed to be inspected" but "due to human error, and inadequate information technology systems, a pre-approval inspection, which would normally be conducted, was not." The agency has inspected a facility in Cherry Hill, N.J., where the finished version of the drug was made, she said.
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