New Study Links Heart Surgery Drug to Increased Risk of Death
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Trasylol linked to increased risk of death. New study reports heart surgery drug increases risk of death.
Aprotinin, a drug commonly used to prevent bleeding during heart surgery increases the risk of dying in the five years after surgery by almost 50 percent. That is the conclusion of a recent study published on Wednesday in JAMA, the Journal of the American Medical Association. The study confirmed another study published last year which identified an increased risk of kidney failure, heart attacks and strokes as a result of using Aprotonin during heart surgery. The researchers stated that replacing aprotinin with cheaper medications currently available would prevent 10,000 deaths over the next 5 years.
The new study is yet another blow to Bayer AG, which sells Aprotinin under the brand name Trasylol. Bayer issued a statement criticizing the study but vowing to "work with regulatory agencies and external experts in the field to further evaluate the findings".
The previous study prompted the FDA to review the drug's safety which had been approved for use in 1993. The FDA has been under mounting criticism to strengthen its post approval safety monitoring program. Just last week the FDA announced plans to evaluate drug safety in the first 18 months of market use.
Aprotinin now joins the ranks of other drugs with serious safety concerns, such as Vioxx and drug-coated heart stents. It is clear that the federal government and drug manufacturers will have to join together to financially support a more effective post-market safety program.
Kiesel Boucher Larson has many years of experience in the field of defective drug litigation. The firm has a team of experts and skilled lawyers who work to protect the rights of injured victims.