On Wednesday, October 27, 2010 B. Braun Medical voluntarily recalled seven lots of its injectable blood thinner heparin citing concerns that they may have been tainted with small amounts of oversulfated chondroitin sulfate (OSCS). Both heparin and OSCS may sound familiar because OSCS is the same substance behind a 2008 heparin disaster resulting in 80 deaths and serious illnesses for hundreds of people. The FDA has been closely monitoring heparin since that scare. In reference to the current situation, B. Braun Medical has stated that they have yet to receive any negative reports concerning the recalled lots, but they are pulling the shipments as a precautionary measure with help from the Food and Drug Administration.
The active pharmaceutical ingredient (API) in the recalled heparin was manufactured by Scientific Protein Laboratories, Inc. of Wisconsin. This same company produced the API that led to the late 2007 heparin crisis that ultimately poisoned hundreds of patients. It was later found to contain as much as fifty percent of a cheap, substitute drug. The poisoned patients experienced anaphylactic-like reactions, low blood pressure, breathing difficulties, nausea, vomiting, diarrhea, and stomach pains. B. Braun Medical announced their latest decision after hearing that Scientific Protein Laboratories had recalled three lots of their heparins active ingredient distributed to manufacturers in the United States, Canada, and Japan.
The heparin from both the past poisonings and the current recall were manufactured with contaminated Chinese products. The raw materials used for the United States heparin imports are intestines from Chinas pig supply. The original poisoning crisis sparked an FDA investigation that eventually identified OSCS as the contaminant. The OSCS was apparently added to create a larger batch of heparin, which is subject to fluctuations in supply connected to the Chinese pig population. Lets hope that this current heparin recall can help prevent the same tragedies of the original crisis.
Have you or a loved one been affected by tainted heparin? A heparin attorney may be able to help.