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Trasylol Aprotinin Injection
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drug_recall aprotinin-trasylolAprotinin Injection
A recent large scale study has shown that aprotinin—brand name Trasylol—can double a patient''s risk of suffering heart attack, kidney failure, stroke, and death.
Aprotinin
Aprotinin, made by Bayer Pharmaceuticals , is a proteinase inhibitor from the bovine lung that is used during cardiopulmonary bypass surgery to reduce blood loss and lower the need for blood transfusions . Aprotinin was approved by the FDA under the name Trasylol in August 1998. It has since been administered to heart surgery patients in over 60 countries across the world.
Known side effects
According to drug labeling for aprotinin, this drug poses the risk of serious allergic reaction . The risk of this aprotinin side effect is increased with repeat exposure to the drug. Upon first exposure to aprotinin, the risk of experiencing anaphylactic shock is less than one percent. Upon repeat exposure, the risk of allergic reaction triples. To avoid the risk of allergic reaction, patients must be given a test dose prior to administration. Other considerations should be made to avoid this aprotinin side effect.
Aprotinin has also been known to increase the risk of other drug side effects including:
- local thrombophlebetic reactions
- abnormal kidney function
- kidney damage
- increased risk of graft closure during primary CABG surgery
- nausea
- and more.
Recent findings about serious aprotinin side effects
A recent study, published in the New England Journal of Medicine , shows that aprotinin can double the risk of
- kidney failure
- stroke
- heart attack
- and death.
This major independent study of Bayer''s aprotinin was conducted by Dr. Dennis Mangano and colleagues from the Ischemic Research and Education Foundation in California.
According to Mangano, the aprotinin study, “raises serious questions about the continued use of Trasylol and suggests far less expensive alternatives are available that are equally effective and safe.”
Alternatives to aprotinin
According to the recent study, two generic drugs— aminocaproic acid and tranexamin acid— achieve the same effects as aprotinin, WITHOUT the serious risk of drug side effects, such as kidney failure, heart attack, stroke, and death. These generic drugs are also much less expensive than aprotinin.
Just like Vioxx
During an interview with the press, Mangano stated that the aprotinin side effects are actually worse than the side effects discovered in connection with the once popular, now recalled, painkiller Vioxx. “Its like a Vioxx II, but a little different. The frequency of adverse events we see is far GREATER with [aprotinin] than with Vioxx ,” he claims.
“The other thing that is disturbing,” says Mangano, “is that the drug has been on the market for thirteen years and a million patients have received it. Why am I coming along now and finding these results and why haven''t they been found yet?” the head researcher asks.
Bayer''s response
Bayer claims that these findings are not consistent with over fifteen years of clinical experience with aprotinin. The company also criticizes the way in which Mangano''s study was conducted, noting that it was not a placebo-controlled double-blind study. Researchers point out that effectively conducting such a study during the post-marketing phase is not possible. Many experts have praised Mangano et al. for their research.
Many doctors are switching to generic alternatives to aprotinin in light of this new safety information.
Have You Been Injured By Aprotinin?
If you or a loved one has been administered aprotinin (Trasylol) and suffered drug side effects such as kidney failure, heart attack, stroke, or death, you may be eligible to seek compensation for your losses and suffering. Please contact us today to speak with a qualified and experienced attorney who can determine your legal rights and options in a free, no obligation consultation.
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