Bayer AG said Friday it suspended two employees involved in the decision to withhold data from federal health officials showing the company’s drug Trasylol can cause deadly side effects.
Bayer, headquartered in Germany, is investigating why a study showing that Trasylol can increase the risk of death, kidney damage, heart failure and stroke was not disclosed at a Sept. 21 meeting with the Food and Drug Administration to assess the safety of the drug. The company did not make the study public until more than a week after the meeting.
Trasylol is the only FDA-approved drug used to reduce blood loss during coronary artery bypass surgery.
Based on preliminary investigations the company believes the decision “was a serious error in judgment by two individuals.” The drug maker also said it retained Fred Fielding of the law firm Wiley Rein & Fielding to conduct an independent investigation of the decision to withhold the data.
The FDA has been reassessing the safety of Trasylol since February, when two separate studies suggested the drug was linked to heart attack, stroke and kidney problems.
More than 600,000 patients worldwide were treated with the drug in 2005, according to Bayer. The company sold $291 million worth of Trasylol last year. Bayer’s annual revenue was $34.7 billion in 2005.