Heparin Contamination leads to Two Heparin Recalls

Heparin is used to decrease the clotting ability of a patient's blood, and is widely referred to as a "blood thinner". Heparin injections may be given to patients before and after cardiac surgery; patients undergoing kidney dialysis and treatment of other medical conditions, including pulmonary emboli and Deep Vein Thrombosis (DVT). Heparin IV bags--used for a Heparin drip--are typically given before or after cardiac surgery; they are not given during surgery. In two separate Heparin contamination recalls spanning approximately two years, both Heparin syringes and Heparin IV bags have been associated with Heparin allergic reactions.

In October 2010, B. Braun Medical Inc announced a nationwide recall of seven lots of Heparin drip Sodium USP Active Pharmaceutical Ingredient (API) after being notified by its supplier, Scientific Protein Laboratories LLC (SPL) that testing of one lot of API sold to Braun indicated a trace amount of over-sulfated chondroitin sulfate (OSCS) contaminant. The recalled Heparin IV lots were manufactured in 2008 and expire on October 31, 2010 and November 30, 2010. It should be noted the the Heparin supplier, SPL, who gave Braun the contaminated Heparin drip lots resulting in this Heparin recall, was the same supplier involved in the 2008 Heparin contamination recall for Heparin injection with Baxter (below).

The recalled Heparin IV drip bags are mainly used in hospitals before and after cardiac surgery. To date, Braun has not received any reports of Heparin side effects, but customers who have the recalled lots of Heparin are urged to discontinue use immediately and be on alert for any potential Heparin allergic reactions.

In January 2008, after receiving reports that a number of patients experienced severe –and even fatal—Heparin allergic reactions, Baxter International recalled nearly all its heparin injections in the US and suspended production of multi-dose vials of the blood-thinning drug. (Since that time, the FDA initiated 13 recalls of multiple contaminated medical products containing Heparin from several companies.)

One month later, the FDA reported 21 deaths and approximately 350 allergic reactions linked to heparin. The Heparin allergic reactions included difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that could lead to life-threatening shock and death. Eighty-one US deaths were ultimately tied to the contaminated Heparin.

Chondroitin sulfate

By March 2008, the FDA confirmed that oversulfated chondroitin sulfate (OSCS) contaminant was found in samples of the active ingredient used in Baxter Heparin. Patients had been exposed to the contaminant via Heparin syringes filled with a product that was not actually Heparin but mimicked Heparin and was therefore not detected.

Heparin is made with raw pig intestines from China. OSCS was added when there wasn't enough raw material, i.e., pig intestines, to meet the Heparin demand. (Swine flu had decreased the pig population and pig populations typically fluctuate; as well, Heparin demand had increased.) Chondroitin sulfate is a widely used, over-the-counter dietary supplement made from animal cartilage and used to treat joint pain. When chondroitin sulfate is altered, or "oversulfated," it mimics the blood-thinning action of Heparin.

Although it isn't clear whether oversulfated chondroitin sulfate was added deliberately or accidentally, the FDA confirmed that the doctored Heparin did not occur naturally or as a result of the manufacturing process. Furthermore, there were some reports that the cost of Heparin had risen dramatically, thanks to an outbreak of swine flu in China. And oversulfated chondroitin sulfate is reportedly cheaper to produce than Heparin.

The FDA said the chondroitin sulfate was molecularly changed to mimic Heparin's blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories LLC (SPL).

The FDA approved the plant in Changzhou to provide Heparin to the US in 2004 but the agency never actually inspected it prior to approving it. Now, the FDA is now under fire for approving Baxter's Heparin without inspecting the plant. The agency has admitted that it violated its own policies by neglecting to inspect SPL's Chinese plant before approving the drug for sale in the US.

Soon after the Baxter recall, B. Braun Medical Inc., a supplier of Heparin in Canada, began recalling Heparin solutions. Both companies used the same supplier—SPL. At the same time, Health Canada announced that the company's Heparin products were tainted. Braun recalled 23 lots (of 25,000 units each) that were distributed to Canada, Australia and the US.

Symptoms of Heparin allergic reaction include a swollen throat, increased sweating, unconsciousness and even death. Heparin side effects also include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.

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Last updated on Nov-23-10