Initial Trasylol Tests Indicate Kidney Damage
Trasylol was developed in the 1980s by the Bayer Company in Cologne, Germany. Bayer began testing its effectiveness in controlling bleeding so that it could be used during heart bypass procedures. Independent studies at the local university were conducted using animals. When it was determined that the tested animals developed serious kidney damage, the results were presented to Bayer, but they still continued their own studies.
The testing of Trasylol moved from animals to humans and the results again showed compromised kidney functions. In 1992, a doctor at the Missouri Baptist Medical Center put together his own test using Trasylol and found that out of 20 patients that were tested, 13 ended up with kidney problems.
Additional testing of the drug continued and each one resulted in kidney malfunction. Even though the FDA was aware of the damage the drug caused to the kidneys, it still approved Trasylol in 1993. Because it did stop excess bleeding, which was its intended purpose, the FDA approved it for people who were at risk of excessive bleeding during surgery. Kidney toxicity was listed as just one of the side effects.
FDA Approval, Warnings and Eventual Recall
If a drug is effective in what it was created for, the FDA will, after enough testing backs its claims, approve its use. The FDA counts on the pharmaceutical companies to ensure the safety of the drug for public use before its approval. Any investigations to the contrary are only conducted by the FDA after approval. In 1998, the FDA approved the use of Trasylol for all heart bypass patients and by 2005 sales of the drug had reached $300 million.
In 2006, another independent test was performed by Dr. Dennis Mangano from San Francisco. His findings showed that after testing 5,065 patients from all over the world, thousands ended up with kidney failure or even died as a result of being administered Trasylol. The results of Dr. Mangano's studies were published in the New England Journal of Medicine.
The FDA finally decided to take some kind of action and advised doctors about possible risks that were linked to the use of Trasylol. A committee meeting was scheduled to meet in 8 months, so to prepare its case, Bayer hired their own doctor, a Harvard professor, to conduct a study for them. Dr. Alexander Walker found "an elevated risk of death and kidney failure" amongst the more than 70,000 patients who were given Trasylol.
At the 2007 committee meeting, Dr. Mangano shared the results of his findings and asked the FDA to have the drug discontinued. Bayer never revealed the results of Dr. Walker's investigation at the meeting.
Because Dr. Mangano's findings were not based on a controlled study with placebos included in the test, and Bayer kept quiet with their damaging test results, Trasylol remained on the market. A week after the meeting, Dr. Walker himself reported not only his findings to the FDA but the fact that Bayer did not divulge these results to the committee. Another meeting was scheduled for the following year.
By 2008 clinical trials were conducted in Canada but they had to be discontinued because too many patients died as a result of being given Trasylol. Germany was the first to ban the use of the drug and the FDA finally got the Bayer Company to cease production.
Throughout its course, over 4.5 million people were given Trasylol. Between the time Dr. Mangano completed his test in 2006 and 2008 when it was pulled from production, 22,000 of the 431,000 patients who were given Trasylol had died.
Filing a Lawsuit for Trasylol Side Effects
If you lost a loved one who was given Trasylol during a surgical procedure or yourself suffered serious side effects from this medication, you may have grounds for a lawsuit. It is important to have a knowledgeable legal professional look over the matter for you in order to determine the best course of action. At Napoli Bern Ripka Shkolnik, LLP, we have helped hundreds upon hundreds of injured patients and their families seek justice after suffering injuries or losses caused by dangerous prescription drugs and defective medical devices. Contact our
pharmaceutical litigation department today to find out how we can help you. We've recovered more than $3 billion in settlements and awards since 2000 alone.