FDA Says There is No Heparin ShortageMar 25, 2008 | Parker Waichman LLP
In spite of three heparin recalls since January, the Food & Drug Administration (FDA) said that there is no shortage of the vital blood thinner. Concerns of a heparin shortage were sparked by Baxter International's recall earlier this year of all of its heparin products after some patients experienced serious, and sometimes fatal, reactions from the drug. Last week, B. Braun Medical Inc. recalled another 23 lots of heparin products, and American Health Packaging, a unit of AmerisourceBergen Corp, said it was voluntarily recalling 1,421 units of heparin injection vials as part of Baxter’ broader recall.
Heparin is a vital drug used in surgery, dialysis, and for the bedridden. Other drugs thin blood, but their effects are not as quick or easily reversed. Baxter manufactures about half of all multiple-dose heparin vials sold in the U.S., while B. Braun Medical supplies 10%-15% of the U.S. supply of injectable heparin. Despite the massive heparin recalls, an FDA spokesperson told the Website Webmd.com that there is no shortage of heparin.
Both Baxter and B. Braun obtain heparin from Scientific Protein Laboratories, which manufactures some of the ingredients in China. Reported reactions to Baxter heparin have included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening. To date, Baxter heparin has been implicated in over 700 adverse reactions and possibly 19 deaths.
There have been similar recalls of Chinese-sourced heparin in Germany and Japan. Last week, the FDA confirmed that it had found chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. However, the agency has not yet determined if the chondroitin sulfate was responsible to the deaths and reactions associated with Baxter heparin.
While the FDA maintains that it has not yet determined if the ingredient substitution was intentional, several sources told The New York Times that it was likely not accidental. Some heparin producers in China also sell chondroitin sulfate, which can be derived from pig cartilage. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.
The heparin contamination scandal has once again raised questions about Chinese manufacturing. According to Consumer Affairs.com, China's exports of heparin and its components totaled $57.8 million in the first half of 2007, a 13.7% increase from the same period a year earlier. The website said 49 companies exported heparin and its ingredients. Many workshops that make crude heparin are unregulated family operations. Baxter has said that its investigators have not been able to get permission from the Chinese to visit these operations, and the FDA has not yet done inspections on any of these facilities either.
Last week, the Chinese State Food and Drug Administration issued an order in a notice seen on its Web site that requires heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers, meanwhile, are required to improve their management and tests on their products, it said. This was a reversal of the Chinese government’s earlier position, as the agency had earlier insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.