FDA to review safety of Trasylol for a second time
The FDA will hold a second advisory panel meeting on September 12, 2007 to review the safety of Bayer AG’s heart surgery aprotonin injection, marketed as Trasylol. Following a prior meeting of experts in September 2006, regulators decided against a Trasylol recall and instead decided to require stronger warnings for the injection and limit its use to certain situations. However, it was discovered after these hearings that Bayer employees withheld information about studies which demonstrated the deadly side effects of the injection.
>>PRIOR POST (12/18/2006): Trasylol heart surgery injection warnings
Trasylol is a heart surgery injection which is administered to reduce blood flow and prevent blood loss during surgery. It has been linked to an increased risk of kidney failure, heart attacks, strokes and death. A study published in February 2007 in the Journal of the American Medical Association reported that individuals who received the heart surgery injection died at a rate two-thirds higher than those who did not receive the drug before surgery to reduce bleeding. Researchers found that one out of every five patients who received Trasylol died within five years.
The FDA will convene a second advisory panel hearing next month to review additional information which has been discovered since their last meeting in September 2006. Bayer has disclosed that two of their senior employees knowingly withheld information from the FDA about problems caused by the heart surgery injection. The company employed a firm to conduct an investigation which found that the failure to provide the damaging information was due to human error, as opposed to a cover-up. However, the fact that the investigation was paid for by Bayer calls into question the validity of the findings.
The advisory panel will make a recommendation to the FDA about what steps should be taken to protect the public. This could include a Trasylol recall if the panel determines that the risk of death and serious injury outweighs the potential benefits provided by the drug. Although the FDA is not required to follow the recommendations of their advisory committees, they usually do.
TRASYLOL LAWSUITS
The lawyers at Saiontz & Kirk, P.A. are investigating Trasylol lawsuits for individuals who suffered from kidney failure, a heart attack, stroke or death following heart surgery where an injection was given to control bleeding. Approximately 60,000 people were given the heart surgery injection in 2006, and if information had been provided about the dangers of this medication many serious and potentially fatal injuries could have been prevented.
Bayer aggressively marketed Trasylol to surgeons who could have used a less expensive and safer alternative if they had been provided accurate information about the risks. It has been estimated that since the drug was approved in 1985, up to 10,000 deaths a year worldwide could have been caused by the heart surgery injection.
If you, a friend or family member received an injection prior to heart surgery and subsequently suffered from kidney failure, a heart attack, stroke or death, request a free consultation.
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