FDA’s Opinion and Actions on Trasylol
A sample study done on a population size of 4,400 Trasylol patients revealed that the use of this medicine in complicated surgeries, though proves beneficial in some specific cases, but by and large increases the health hazards by manifolds. The rate of increase of the most significant and fatal side effects is listed as below:
|S.No||Health Problem||Rate of Increase|
|1||Risk of Heart Attacks||Increase by 48%|
|2||Risk of Heart Failure||Increase by 109%|
|3||Risk of Heart stroke||Increase by 181%|
This study was published in the New England Journal of Medicine during January 2006.
This particular study and its subsequent findings compelled FDA to assess the secure and unsecure aspects of the drug and the risks involved with it. FDA also made it a point to spread awareness of the adverse side effects of the drug amongst all the practitioners and hospitals, and limit the use of this medicine to the only situation wherein the benefits could have outweighed the risks involved. FDA concluded the health advisory by issuing a statement that Trasylol was neither safe nor essential in the event of complicated surgeries like coronary artery bypass graft. However, soon after FDA took a decision and conveyed Bayer Pharmaceuticals Corporation for a marketing suspension of the medicine.
The serious outcomes like that of renal failure, heart strokes, etc. forced FDA to take this extreme step. FDA’s decision to withhold the medicine was taken keeping the interest and safety of patients in mind. At the same time, FDA could not take this step hastily, as it would have caused shortages of the other drugs used for similar purpose. In the meantime, since it was almost impossible to track the number of people undergoing heart surgeries, FDA made it a point to make limited access of Trasylol available to the practitioners.
FDA worked in association with Bayer- the manufacturer, Ottawa Health Research Institute’s study researchers and many other regulatory agencies to do a thorough analysis of data and get a crystal clear picture of the probable risks and benefits of this medicine. After finishing this research, on 15th May 2008 FDA asked Bayer to completely remove the entire stock from the U.S. market. As per FDA’s instructions the drug should only be available for investigational use that too only for those patients who have got no other alternatives left with them.
Though the exact number of deaths caused by the use of Trasylol is uncertain, still a rough estimate given by one of the researchers gives an approximate figure of 1000 lives per month during the year 2006 and 2007. Another assumption that floats in the market is that FDA had mistakenly approved this drug in the year 1993. Then it collected a substantial amount of data as a proof that the patients were suffering from renal failure, heart strokes and even deaths, and accepted in the year 1998 that it took a wrong step in giving Trasylol a green go. Keeping in mind all the data that FDA received, together with the studies done by Dr. Fischer and Dr. Mangano, FDA recalled its approval to the Trasylol drug in the year 2007 and hence marked an end to the generic aprotinin.