Baxter says its heparin not to blame for injuries

NEW YORK, May 15 (Reuters) - Baxter International Inc (BAX.N) said on Friday its premix heparin products were not to blame for serious injuries suffered by three patients in a Delaware hospital who received the company's blood thinner.

Baxter said it and the U.S. Food and Drug Administration investigated the injury reports after being contacted by Beebe Medical Center in Lewes, Delaware about patients who experienced intracranial bleeding -- a serious, life-threatening condition.

"Following extensive product testing and further medical evaluation, we are confident that the events at Beebe Medical Center are unfortunate, isolated, institution-specific issues, unrelated to the quality of Baxter's heparin premix product," Baxter official Camille Farhat said in a statement.

Heparin is widely used in hospitals to reduce blood clotting during and after open heart surgery and to treat many medical conditions, including acute coronary syndrome, atrial fibrillation, deep-vein thrombosis and pulmonary embolisms.

All tests on samples obtained from the hospital, retained samples from the same lot, and samples produced before and after the lot in question confirmed that the product's formulation was within specifications and met all requirements, Baxter said.

An FDA spokeswoman, Karen Riley, said based on information gathered so far "we don't see a quality problem with the product."

Baxter was at the center of a major heparin recall in 2007 after purchasing a contaminated supply from China.

The contaminated heparin led to at least 81 deaths and hundreds of other adverse events, putting the drug under intense scrutiny. (Reporting by Bill Berkrot, Lisa Richwine in Washington; Editing by Richard Chang)