The move was disclosed this afternoon by the FDA, which provided an update on the controversy over side effects and deaths linked to Baxter's widely used blood thinner. During the teleconference with the media, agency officials said they had completed an inspection of the Chinese facility that supplied the active pharmaceutical ingredient to Baxter, but have still not identified the 'root cause' of the problem.
"We've identified a number of potentially objectionable conditions," said Michael Rogers, director of the Division of Field Investigations in the FDA's Office of Regulatory Affairs, who added that the supplier isn't currently manufacturing. Among the problems he cited with the plant in Changzhou, China, which is owned by Scientific Protein Laboratories, were waste material flow, difficulties removing impurities, and process validation and control.
These are all terms that, typically, appear on an FDA inspection form known as a 483, which essentially is a technical laundry list of deficiencies and red lights. The agency intends to make a redacted form of the 483 available on its web site, but failed to do so prior to the teleconference, which robbed the media of a chance to ask detailed questions about the problems at the plant. You may recall that the FDA never inspected the plant due to a paperwork mix-up, despite a policy that calls for inspecting plants that supply the US.
Meanwhile, the FDA has received 448 reports of adverse events associated with Heparin, of which 389 are known to have been Baxter's version. However, just 215 are 'of interest' to the agency, according to Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. She adds that 21 deaths were reported involving people who had been given Heparin, although the number that displayed the type of allergic reaction that caused concern initially continues to remain at four.
"We understand how unsettling this whole situation is," said Kweder. "We are doing everything possible...We are determined to get to the root cause."
As for the Baxter recall, single-dose vials have now been withdrawn, because an alternate supplier for the blood thinner is now able to provide adequate supplies. Until now, only multiple-dose vials had been removed from the market. Baxter also withdrew another Heparin product that is a dilution that prevents clots from forming in IV lines, a step that Kweder described as 'voluntary and precautionary.'