Drug & Device News

Despite the fact that Bayer Pharmaceuticals representatives participated in a Food and Drug Admin-istration (FDA) public meeting Sept. 21, held to assist the Agency in assessing the safety of Bayer's drug Trasylol' (aprotinin injection), they made no mention of a troubling study Bayer had conducted that found several potential life-threatening problems with the heart surgery medicine. On Sept. 29, the FDA announced, 'FDA was not aware of these new data when it held the Sept. 21, 2006, Advisory Committee meeting on Trasylol safety. FDA is actively evaluating these new data and their implications for appropriate use of the drug.' The new data show that use of Trasylol may increase the chance of death, serious kidney damage, congestive heart failure and strokes. The FDA has advised that, while it conducts its evaluation of both the new and old safety information, physicians should continue using Trasylol where needed but carefully monitor patients for the occurrence of toxicity, particularly in the kidneys, heart, or brain.

After acknowledging that the failure to disclose was 'a mistake,' a release from Bayer stated, 'This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology. Bayer believes that despite the highly preliminary nature of this data, the information should have been shared with the FDA prior to the Sept. 21 Advisory Committee meeting held to assess the safety and efficacy of Trasylol. This was a mistake on the company's part.'