FDA: No Shortage of Heparin
Recalls of Blood-Thinning Drug Have Not Created a Supply Problem
March 24, 2008 -- Federal regulators say supplies of heparin, a widely used blood-thinning drug, have not been interrupted despite a third recall issued late last week.
B. Braun Medical Inc. announced a recall last week of 23 lots of injectable heparin manufactured and distributed in the U.S. and Canada. It followed a recall in late February of Heparin in single and multiple dose vials made by Baxter Healthcare Corp.
B. Braun Medical supplies 10%-15% of the U.S. supply of injectable heparin, according to a company statement.
Heparin is a blood-thinning drug used to prevent blood clots in patients. The recalls removed millions of heparin doses from the market but have not caused any shortages of the drug, says Karen Reilly, an FDA spokeswoman.
"There's no supply problem," Reilly says.
Both Baxter and B. Braun Medical used ingredients from Scientific Protein Laboratories, which manufactured heparin ingredients in a factory in China. An active pharmaceutical ingredient produced at the plant is suspected of being the source of adverse reactions that prompted the recalls.
The reactions to Baxter's heparin included nausea, vomiting, and rapid drops in blood pressure in some patients who received the drug. Deaths have also been reported after receiving contaminated heparin, though agency officials have said that they cannot conclusively link the deaths to the contamination.
B. Braun Medical has not received any reports of adverse reactions to its heparin products, company spokesman Rick Williamson said in a statement. He called the recall "a precautionary measure."