U.S. regulators are criticizing Baxter International Inc.’s promotion for the bleeding treatment FEIBA VH. The U.S. Food and Drug Administration (FDA) says the promotion misleads doctors about the drug’s safety and effectiveness.
A “clinical thank you email” submitted for review by Baxter to the FDA, violates FDA policies by saying FEIBA VH works better and causes fewer side effects than has been proven in studies; this, according to a letter to the company posted on the FDA’s Web site. FEIBA VH contains sterile, freeze-dried human protein that controls spontaneous or surgery-related bleeding in patients with hemophilia. “By promoting misleading safety and efficacy claims, you are potentially encouraging the unsafe use of FEIBA VH,” the FDA said in July 7 letter. The FDA ordered Baxter to cease using the email and any promotions that exaggerate FEIBA VH’s safety and effectiveness.
According to Baxter spokeswoman Deborah Spak, Baxter is working with the FDA to revise its promotional statements and add context to support them. Baxter is the world’s largest maker of blood-disease treatments.
Most recently, tainted Heparin manufactured by Baxter International has been directly linked to the deaths of three people, according to the FDA. Earlier this year, the FDA received over 90 reports of deaths and more than 1,000 adverse events associated with patients in the U.S. who had one or more allergic reactions to heparin products, including those sold by Baxter since January 1, 2007. This January, Baxter recalled nearly all its Heparin injections in the US after some patients experienced extreme, sometimes fatal, allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. Baxter came under FDA scrutiny in January after recalling supplies of the blood-thinner Heparin linked to allergic reactions and deaths. The FDA found the drug to be contaminated with a cheaper ingredient from China. Chinese officials disputed the cause of the reactions. There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France, Germany, and Japan. In total, the FDA said tainted heparin was identified in 12 countries. In the US, other heparin suppliers issued precautionary recalls, and some medical devices makers recalled Heparin-coated products.
In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter 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. It costs a fraction of the ingredient usually used in Heparin, and producers may have used it in an attempt to cut costs. In April, a research team, led by scientists at MIT, found chondroitin sulfate activates two inflammatory pathways: One that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second, to a serious allergic reaction.
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