Baxter Recalls Rest of Heparin Products ( Investigation into allergic reactions...)

Baxter Recalls Rest of Heparin Products

Date:2/28/2008

Investigation into allergic reactions, deaths related to blood thinner continues

THURSDAY, Feb. 28 (HealthDay News) -- Baxter Healthcare Corp., the pharmaceutical company at the center of recent problems with its blood thinner heparin, announced Thursday that it was recalling any remaining multi-dose vials of the drug as well as single-dose vials.

The company also said it was recalling its Hep-Lock heparin flush products, which contain a small amount of heparin and are used to prevent blood clots in intravenous lines.

The recalls were made possible because the other manufacturer of multi-dose heparin vials -- APP Pharmaceuticals of Schaumburg, Ill. -- was able to assure the U.S. Food and Drug Administration that it could meet the demand for the blood thinner in the United States.

"At the time [in January] when Baxter stopped production of its multi-dose heparin, we determined there would be an immediate and severe shortage of this medically necessary drug," Rear Admiral Dr. Sandra Kweder, deputy director of FDA's Office of New Drugs in the Center for Drug Evaluation and Research, said during an afternoon teleconference Thursday. "Therefore, it was in the interest of the public health to allow multi-dose vials to remain on the market, but to be used with caution."

"Today," Kweder added, "we can report that APP is now able to adequately supply the U.S. market."

As far as Baxter's Hep-Lock products are concerned, there are several manufacturers of similar items, Kweder added.

"We have assurance from the U.S. Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs," Peter J. Arduini, president of Baxter's Medication Delivery business, said in a statement. "The safety and quality of our products is always our highest priority, and we will continue to collaborate with the FDA as we work to determine the cause of t
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