The Food and Drug Administration is investigating whether an ingredient from China may be the source of problems with a blood thinner linked to hundreds of reports of severe allergic reactions and possibly several deaths.
Some of the active ingredient in the drug heparin from Baxter Healthcare Corp. was probably made in China, but the FDA and the manufacturer say it is too early to say whether the complications were caused by that ingredient.
Some patients who received heparin experienced difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that can lead to life-threatening shock, the FDA said. The agency said four people had died after receiving heparin, though the link to the drug was unclear.
Calls to China's State Food and Drug Administration in Beijing went unanswered.
As with food ingredients, China in recent years has become a major exporter of active pharmaceutical ingredients. Medicine Economic News, citing China's customs statistics, reported that the nation'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 Guangzhou-based publication said 49 companies exported heparin and its ingredients.
Baxter announced Monday that it was suspending manufacture of multiple-dose vials of heparin. The injectable drug, which is derived from pig intestines, is used to prevent dangerous blood clots from forming during certain types of surgery, including heart bypass. Baxter accounts for about half the U.S. market for the drug.
Baxter spokeswoman Erin Gardiner said Wednesday evening that some of the active ingredient probably was made in China because Baxter got its supply from another company that had manufacturing facilities in the U.S. and in China.
Baxter wasn't identifying the source, but Gardiner said the supplier had been manufacturing heparin for more than 30 years and had been supplying Baxter for more than 20 years. She said the plant in China had been in operation for several years.
Baxter inspected the supplier's U.S. facility and its China plant last year, and both have good records in terms of safety and quality, the company said. The FDA has not inspected the plant in China, the agency said.
Times staff writer Don Lee in Shanghai contributed to this report.