WASHINGTON -- A second American company recalled Heparin products yesterday as China announced that it was clamping down on production of the blood-thinning drug's main ingredient to prevent further cases of contamination.
B. Braun Medical Inc. withdrew 23 lots of Heparin products after learning that it had received a contaminated ingredient. The Bethlehem, Pa., company described the recall as precautionary. It said it had not received any reports of side effects, even though the suspect lots have been sold in the United States and Canada.
The products are intravenous-solution bags used for patients who need low doses of Heparin during hospital stays, the U.S. Food and Drug Administration said. B. Braun is a relatively small Heparin seller with one-tenth of the market for the premixed bags, a company spokeswoman said. It is still making the product, since just one lot of supplies was contaminated, the FDA said.
B. Braun is the second to recall Heparin products. Baxter International Inc., of Deerfield, Ill., was the first to withdraw, recalling many of its Heparin products last month. Baxter and B. Braun bought the main ingredient from the same firm, Scientific Protein Laboratories. The Waunakee, Wis., company notified B. Braun of the contaminated supplies, prompting the latest recall. As many as 19 Americans have died and hundreds reported serious side effects.
On Wednesday, the FDA identified the contaminant as a chemically-treated version of a common dietary supplement not approved for use in prescription drugs.
Investigators are still trying to confirm whether the chemical - over-sulfated chondroitin sulfate - caused the severe allergic reactions. They are also probing whether the chemical was used deliberately as a way to make more money. The scare has renewed criticism of FDA inspections and Chinese products.
Heparin's main ingredient comes from pig intestines. China is the world's leading provider of the raw materials, though a virus reduced the number of pigs last year, depleting supplies. Scientific Protein Laboratories made the ingredient at a plant in eastern China that the company partly owned.
On Thursday, China ordered Heparin producers to get their raw materials only from registered suppliers and directed those 23 suppliers to test their products for contamination, the official news agency said.
The Xinhua News Agency reported that Chinese drug regulators told Heparin makers to follow approved manufacturing techniques. Regulators also required Heparin makers and exporters to look for signs of side effects among users of their products, issuing recalls if they found anything. Regulators directed local inspectors to step up monitoring, the wire service said.
China's drug regulators had resisted taking action, saying American importers and regulators were responsible for assuring the quality of shipments. Yet the culpability of Chinese suppliers has appeared more and more likely, and the scare has exacerbated U.S. fears about importing goods from China.
Also on Thursday, China's Ministry of Commerce expressed concern about the contamination and ordered exporters to test Heparin products more closely, the Xinhua News Agency said.
jonathan.rockoff@baltsun.com
