Heparin
Serious injuries and death associated with blood-thinning drug Heparin
Keywords: Heparin | Attorney | Santa Rosa | Lawyer | Lawsuit | Adverse Side Effects | Allergy | Allergic Reaction
Heparin is a blood thinner (anticoagulant) used to prevent the formation of blood clots in the veins, arteries, and lungs. Baxter Healthcare Corporation manufactures approximately half of the multi-dose Heparin vials sold in the United States. In February 2008, Baxter recalled Heparin after hundreds of patients suffered life-threatening and even fatal reactions to the contaminated drug.
Adverse reactions to Heparin primarily occurred after one of the following procedures: renal dialysis, invasive cardiovascular procedures (such as heart bypass surgery), and apheresis procedures (where the blood is separated into components to remove toxins or other substances). Defective Heparin has also been found in certain medical devices. Reactions typically occur immediately following exposure to Heparin, but can sometimes appear hours later. Symptoms include:
- difficulty breathing
- fainting
- nausea
- excessive sweating
- rapidly falling blood pressure (hypotension)
- rapid heartbeat
- shock
- death
The long term health effects of exposure to contaminated Heparin are unknown.
The active pharmaceutical ingredient in Heparin is derived from pig intestines. Baxter obtained this active ingredient from the Changzhou SPL Company in China. By January 2008, the FDA received numerous reports of serious allergic reactions and severe hypotension (low blood pressure) caused by Baxter Heparin. After receiving these reports, the FDA inspected the Changzhou plant for the first time and, subsequently, determined that Heparin's active ingredient was contaminated by oversulfated chondroitin sulfate.
During its inspection, the FDA discovered that Baxter's supplier in China had committed serious violations of U.S. Good Manufacturing Practice (GMP) requirements. These federal regulations require manufacturers to establish a quality control system to assure the safety and effectiveness of medical devices sold in the United States.
Prior to receiving notice of the adverse reactions to Heparin, the FDA had never inspected the Changzhou factory nor had Baxter alerted the FDA to its inspection oversight. Furthermore, Baxter and the FDA were aware of drug's dangerous propensities well before the recall, yet allowed the drug to remain on the market – causing needless additional injuries.
Additional Information on Heparin
FDA Recall Press Release
FDA News Feb. 11, 2008
FDA Heparin Info
FDA Adverse Events Info
Lawsuit
Our firm is currently evaluating the claims of individuals injured by Baxter Heparin. For a free and confidential consultation, please fill out the form to the right or contact attorney Tarik J. Naber at (707) 545-1660 or tnaber@gsoglaw.com.
