Four years later, the FDA is still uncovering perps in the tainted heparin scandal. The agency said it found 14 more Chinese companies that supplied contaminated raw heparin back in 2008, when the blood thinner was linked to at least 80 U.S. deaths. As The Wall Street Journal reports, the companies were added to an import alert, meaning their shipments can be stopped at U.S. borders.
The investigation began after heparin batches were tied to hundreds of allergic reactions, some so severe they killed patients. Marketed by Baxter International ($BAX), the blood thinner had been tainted somewhere along the supply chain, which stretched into some mom-and-pop workshops in the Chinese countryside. Crude heparin is derived from pig intestines, and there are likely hundreds of suppliers in China because it's a big pork producer, the agency noted.
The FDA had already put 8 Chinese suppliers on its heparin black list, so now the import alert covers 22 companies. The agency doesn't have any evidence the 14 newly identified suppliers are shipping contaminated raw materials now, an agency official told the WSJ. Nor is the agency worried the tainted versions of the drug have made their way into the country.
Since the 2008 scandal, the FDA developed tests to detect the chemical culprit--oversulfated chondroitin sulfate--and requires manufacturers to check their products. "The heparin supply is safe," deputy commissioner Deborah Autor told the Journal. "It's one of the most protected drugs out there."
The agency forwarded the new import alert list to 27 companies that make heparin, asking them to check their supply chains, the WSJ says. Agency officials said the listed companies supply raw heparin to other Chinese makers that produce the drug's actual active ingredient, so they're probably not directly importing raw materials into the U.S. in any case.
- get the FDA import alert
- see the WSJ piece