Feb. 28, 2008 -- Baxter, maker of about half of the U.S. heparin supply, today recalled all of its heparin products.
But there's no shortage of the commonly used blood thinner. Heparin maker APP, which generates the other half of the U.S. supply, has upped production.
The products include single-use and multi-use vials of heparin, as well as "heparin lock flush products" used to clear IV lines. Heparin is widely used as a blood thinner to prevent clotting during surgeries, dialysis, and other procedures.
In a news conference today, Sandra Kweder, MD, deputy director of the FDA's office of new drugs, said there have been 448 reports of adverse events in patients receiving heparin, of which 389 identified Baxter products as the source. Twenty-one patients have died.
But Kweder said that many of these reports may be duplicates or may have nothing to do with the use of heparin in severely ill surgery patients. However, four of the deaths appear to be from allergic reactions having "the same clinical picture," Kweder said.
"We at FDA understand how unsettling this report is for health care professionals and patients," Kweder said. "So far, the underlying cause of these adverse events is unknown. We are doing everything possible -- we are determined -- to get to the cause of these adverse events."
The FDA's investigation has led to an inspection of a Chinese factory, Changzhou SPL, which supplied Baxter with heparin. The FDA inspection team found the plant was no longer manufacturing heparin, Michael Rogers, FDA field investigations director, said at the news conference.
Raw materials for heparin come from pig intestines. Rogers said the initial investigation of the Chinese plant "identified a number of potentially objectionable conditions" including steps to remove impurities, reporting of self-inspection results, "issues related to waste materials flow," and equipment.
The investigation is going beyond the SPL facility to follow the flow of raw materials -- pig intestines -- to their source. These sources include small workshops and farms in remote areas of China. Rogers praised Chinese authorities for their cooperation with the investigation.
It is not yet clear whether the Chinese raw materials or manufacturing process actually had anything to do with the adverse events and deaths of U.S. patients.
So far, it seems that Baxter heparin products are the only ones affected. However, Kweder said the FDA has asked doctors to report any adverse events following the use of any heparin products.
Kweder said the recall was delayed in order to ensure a continuous supply of heparin. She said nearly all of the product already has been given to patients, so few doses of the drug will actually be sent back to Baxter.