Baxter: Latest Heparin Deaths, Injuries Not Our Fault

Drug maker Baxter International Inc. says its blood-thinning drug heparin is not responsible for the recent deaths of two patients and severe injury to a third at a Delaware hospital.

Earlier this week, officials at Beebe Medical Center in Lewes notified Baxter and the Food and Drug Administration that patients had died or been severely injured after being given heparin. The drug is commonly given in hospitals across the United States to prevent blood clots from forming during open-heart surgery and to treat heart conditions such as atrial fibrillation, acute coronary syndrome, and pulmonary embolisms.

All three patients who were treated with heparin at Beebe developed the severe, life-threatening condition called intracranial bleeding, officials said.

Baxter said today that an investigation into the premix heparin products used at the Delaware hospital were not to blame for the patient deaths.

“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 said in a statement.

Investigation Finds No Link to Heparin

The investigation conducted by Baxter and the FDA determined that the intravenous forms of heparin administered at the hospital was not contaminated and was formulated properly, officials said.

“We don’t see a quality problem with the product,” the FDA said in a statement.

Other Heparin Controversies

In 2007, Baxter heparin was the subject of a massive recall after the drug was found to be contaminated with a counterfeit active ingredient supplied by a Chinese firm that manufactured the drug for Baxter. At least 81 people died and hundreds more suffered serious side effects from the contaminated heparin.

Heparin also has been the subject of controversy for packaging and labeling that has caused confusion between full strength heparin and a diluted form of the drug, called HepLock, which is designed for use in children. Heparin and HepLock have been sold in vials that are the same size and shape and carry labeling that is similar in color and appearance.

There have been reports of pharmacists, nurses, and other healthcare professionals mistaking heparin and HepLock and administering deadly overdoses of the drug to newborns. In one of the most high-profile cases of such a mix up, the newborn twins of actor Dennis Quaid and his wife nearly died when they were given massive overdoses of heparin instead of HepLock.

The Quaids later testified before a Congressional hearing about the need for changes in the labeling of heparin and HepLock to prevent such tragedies in the future.

No related posts.