Temporary halt to Heparin production
Baxter international has temporarily stopped making the blood thinning medication Heparin in multi-dose vials after four US patients who took the drug died and hundreds of others became ill.
The US Food and Drug Administration (FDA) said it had received about 350 reports of health problems associated with Baxter’s injectable heparin product since the end of 2007.
The FDA has advised doctors to use an alternative source of heparin or another blood-thinning agent when possible and said it was investigating whether similar problems had been seen with heparin made by other manufacturers.
Patients reported side effects that included difficulty breathing, nausea, vomiting, excessive sweating and rapid drop in blood pressure. Almost all the adverse reactions were seen in patients who received a “bolus” dose, or high dose given over a short period of time, FDA said.
Heparin, which has been in widespread clinical use since the 1930s, is administered in operating rooms and other critical care areas to prevent blood clots and is crucial in hemodialysis and heart surgery.