Germany Recalls Heparin, But Source Is Different
Make a commentBy Ed Silverman // March 6th, 2008 // 4:10 pm
The Heparin scandal is taking on international dimensions. The FDA says that German regulators have now received reports of serious adverse events caused by Heparin, but this version of the blood thinner doesn’t contain an active ingredient made by the Chinese company that supplied Baxter International. However, the agency didn’t identify the source of the Heparin that is causing problems in Germany, other than to say the supplier is not a US company. The German manufacturer is Rotexmedica.
It remains unclear, though, the extent to which the problem may extend to other versions of Heparin made by still other companies in other countries. The investigation is “still evolving,” says Janet Woodcock, an FDA deputy commish, during a telebriefing with the media. She did, however, attempt to downplay concerns that the health authorities are now facing a worldwide problem. “I don’t think we have a global concern.” Nonetheless, the agency wants all US suppliers to conduct specialized tests to ensure that their products don’t contain the contaminant.
FDA officials say they learned this morning of the serious reactions in Germany, where dialysis centers and doctors have separately reported clusters of side effects. Fewer than 100 adverse events were reported, but no deaths. Yesterday, the FDA said Baxter’s blood thinner that has been linked to nearly 800 serious side effect reports and at least 19 deaths in the US.
The agency says it is still attempting to identify the contaminant that was found in the active ingredient and finished product sold by Baxter. The contaminant was described as a ‘Heparin-like compound’ and it accounted for between 5 percent and 20 percent of the active pharmaceutical ingredient and finished product tested. Woodcock reiterated that there is “no direct causal link between the contaminant and the adverse events.”