Recall of BAXTER HEPARIN Sodium Injection and Lock Flush Solution

 

On February 11, 2008, the US Food and Drug Administration (FDA) issued a Public Health Advisory to alert the public about reports of serious adverse events in patients who had received bolus injections of heparin sodium manufactured by the Baxter Healthcare Corporation. The advisory was updated on February 28, 2008 to announce that Baxter is recalling single- and multi-dose vials of heparin sodium for injection and its heparin lock flush products.

Heparin sodium is a blood thinner (anticoagulant) usually administered directly into the blood stream (intravenously) in patients undergoing certain types of cardiac surgery and kidney dialysis. It is also used to treat and prevent obstruction of blood vessels in the lungs (pulmonary emboli) and blood clots in deep veins (deep venous thrombosis - DVT).

The serious adverse events that prompted the recalls occurred in patients who had received high doses (5000 to 50,000 units) intravenously over a short period of time, usually a few minutes (as a bolus), and included hypersensitivity-type or allergic reactions and dangerously low blood pressure (severe hypotension). Symptoms included nausea, sweating, oral swelling, vomiting, and shortness of breath. Most of these events developed within minutes of the bolus, but the possibility of a delayed reaction has not been ruled out.

The FDA has not identified the cause of the problem, but is investigating two Chinese wholesalers that supplied crude heparin to the Changzhou SPL plant that provided much of the active ingredient for the suspected heparin. The New York Times reported that at least one of the wholesalers received supplies from unregulated "family workshops". Some of these workshops have been known to produce crude heparin by scraping mucous membranes from pig intestines and cooking it. Baxter's lock flush solution was recalled as a precautionary measure because its active ingredient came from the same plant.

Because Baxter was manufacturing about half of the heparin sodium used in the US, the recalls initially raised concerns over shortages of the critical, life-saving drug. The FDA, however, has been working with APP Pharmaceuticals and other manufacturers to increase production of heparin sodium. Other suppliers of heparin sodium for injection include Hospira and B. Braun. Heparin production is expected to increase sufficiently to meet US demand.

Baxter's own recall notice advises health care providers to discontinue the use of and segregate the recalled heparin from the rest of their inventory. They have offered to arrange for the return and replacement of the drug by contacting them at 1-800-4-BAXTER (1-800-422-9837). Those who purchased the drug indirectly are urged to contact the distributor for return and replacement.