Trasylol® (Aprotinin injection) is an amino acid derived from the lung tissue of cows.
Bayer manufactured Trasylol and originally set forth its indication for use as:
“For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery”
The FDA approved Trasylol in 1993, for use in cardiopulmonary bypass grafting surgery to reduce perioperative blood loss and eliminate the need for blood transfusion. Ultimately, a black box warning was added to the label cautioning about the potential for anaphylactic reactionsin patients.
Since 1994, the numbers of patients having Trasylol administered has steadily increased from 27,000 to 246,000 in 2005. After going market, 41% of the Bayer postmarketing reports were for hypersensitivity reactions and a sponsor study demonstrated over 18% of the anaphylactic shock cases resulted in deaths.
In the context of Trasylol, the term anaphylaxis included:
- Cardiovascular events
- Cardiac arrest
- Respiratory events
- Dermatologic events
In 2006, the FDA Drugs Advisory Committee met to evaluate the risk of Trasylol and the findings of two different studies of it. One study by Mangano indicated that Trasylol carried with it an increased incident of renal complications, congestive heart failure, and stroke. Unfortunately, Mangano was not able to provide full disclosure of his data, due to confidentiality issues.
Surprisingly and not until after the FDA had met did Bayer finally disclose that it had conducted a study involving 67,000 patients and that study clearly demonstrated the very complications raised by the Mangano study.
Bayer may not have revealed its retrospective study to the FDA if the author of that study, Harvard investigator, Dr. Alexander Walker, had not “blown the whistle. When he noticed that Bayer had not mentioned its study to the FDA during the September 21, 2006 meeting on Trasylol® safety, Dr. Walker promptly notified the FDA that there was such a study.