The Food and Drug Administration and Baxter International Inc. have notified doctors that the drug Heparin could be linked to thrombosis or blood clots in patients several weeks after they stop taking it, the agency said Friday.
The FDA said it revised the warnings section of the prescribing information for Heparin, a blood thinner, because of the possibility of delayed onset of thrombocytopenia and thrombosis. The agency described that as a “serious antibody-mediated reaction resulting from irreversible aggregation of platelets.”
“Thrombotic events may be the initial presentation for heparin-induced thrombocytopenia and thrombosis which can occur up to several weeks after the discontinuation of heparin therapy,” the FDA said in a notice.
Baxter spokeswoman Erin Gardiner said the company asked the FDA to add the new labeling language to reflect current medical literature on the drug, as a reminder to doctors to monitor patients for the potential effects. Heparin is available in generic form and sold by other companies as well.
The move was not prompted by any recent increase in adverse events or complaints about the product, she added.
The prescribing information for Heparin also includes the warning that the drug may cause pulmonary embolism, cerebral blood clots, strokes, skin necrosis, and gangrene in arms and legs that could lead to amputation and possible death.
Heparin is typically administered intravenously to thin a patient’s blood when there is a danger of clotting.
The drug generates annual sales of about $30 million, Baxter said.