Blood Thinner Lovenox Recalled Over Contamination ConcernsMay 18, 2008 | Parker Waichman LLP
French health authorities have just ordered the recall of 11 batches of Sanofi-Aventis' anti-clotting drug Lovenox. The withdrawal is taking place as a precautionary measure over concerns about a possible contamination. France's Health Products Safety Agency said the 11 batches showed abnormally high levels of over-sulphated chondroitin sulphate in one of the drug's ingredients.
Levels of the contaminant were “much lower” than those found in recent cases of contaminated Heparin in the United States and Germany, the agency added; however, similar recalls have also occurred in Sweden, Australia, and Spain.
In the US, reports of serious reactions linked to Heparin numbered over 700 with an estimated 21 deaths. Baxter International, Inc., recalled virtually all of its Heparin products in the US; at the time, companies in Germany and Japan also recalled their Heparin products.
Heparin is a blood thinner administered in surgery and other critical care areas to prevent blood clots, is crucial in dialysis and heart surgery, and is used for the bedridden. Other drugs thin blood, but their effects are not as quick or as easily reversed. Heparin, which has been manufactured since 1930, is administered to millions of patients yearly and although Heparin has been used safely by millions of Americans, the bad batch of the drug sickened hundreds and killed dozens because it contained a contaminated ingredient that remains under investigation. The batch was made in China.
Heparin investigators were focusing efforts on recalled products that contained a contaminant that mimicked the drug's key ingredient and were investigating whether the possible counterfeit was responsible. Since the key ingredient came from China, fears about the integrity of exports from China and the adequacy of inspections by the FDA were heightened, prompted congressional hearings.
"I don't think the pharmaceutical industry knows what it's doing in China and I don't think the US government knows what it's doing in China," said Michael Santoro, a Rutgers University business professor who has written about the drug industry's business in China. Santoro said the Baxter recalls show the need for serious restrictions on Chinese drug imports.
The FDA admitted it violated its own policy by failing to inspect the Chinese plant that manufactured the Baxter Heparin prior to shipping the Heparin ingredient to Baxter in 2004; China’s drug agency did not inspect the plant. Also, the agency sent inspectors to the plant and found a failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment and, according to an inspection report released by the agency, the SPL plant appeared to have made at least some Heparin with “material from an unacceptable workshop vendor.”
Germany's drug regulator, the Federal Institute for Drugs and Medical Devices, also issued a recall for supplies of the blood thinner Heparin after severe allergic reactions to the drug were reported; an additional warning for dialysis patients was also issued. "We urgently suspect that they (the drugs) may be contaminated," said Axel Thiele from the German regulator. Thiele also said Germany experienced about 80 cases of allergic reactions linked to heparin that included breathing problems, accelerated heart beat, and low blood pressure.