This should send shivers down the spine of anyone considering more importation of drugs with foreign regulation substituted for American regulation. Notice it was caught first in the US even though it appears the contaminated or misformulated drugs were shipped to at least one other country. For some reason I expect other countries to discover they have received similar shipments now that the US expoosed the problem.
Heparin Stopped at the Border
By MedHeadlines • Mar 15th, 2008 • Category: Drugs, FDA, Poisoning, Prevention, Recalls
On Friday, the US Food and Drug Administration (FDA) announced that it is taking action against shipments of heparin coming into the country from China after an influx of reports describing allergic reactions, including four fatalities, which may be linked to contaminated product. All shipments reaching the US border will now be tested for contamination before further distribution.
Heparin, a popular blood-thinning prescription medication, has been linked to more than 700 allergic reactions in the US since January 1, 2007. It is believed to be associated with 19 deaths, however FDA spokesperson Janet Woodcock says there have been no new deaths reported since February 28.
The current heparin import alert focuses on heparin produced by Baxter International Inc., of Wisconsin. Baxter gets its active ingredient from Scientific Protein Laboratories LLC (SPL), headquartered in Waunakee, Wisconsin. SPL, which maintains plants in China and Wisconsin, claims it is too soon to tell if the contaminated products come from its Chinese facility.
FDA officials announced last week that they discovered a significant amount of a suspicious substance, thought to be a contaminant, in samples of some recalled heparin and in the active ingredient used to manufacture it. The substance is said to be “heparin-like” but it has yet to be identified exactly. Baxter issued a recall of most of its heparin products last month after receiving reports of adverse allergic reactions.
A heparin manufacturer in Germany issued reports of contaminated heparin last week and ordered a recall of all its products. Rotexmedica GmbH also purchases heparin ingredients from China but not from SPL. Samples of the products Rotexmedica receives from its Chinese supplier, Yantai Dongcheng Biochemicals, is being compared to the heparin recalled by Baxter.
From: Nikole Wollerstein Read Replies (2) of 242349 |
