Bayer Says It Mistakenly Failed to Disclose Data

German drug maker Bayer mistakenly failed to inform U.S. regulators about a study on the risks of widely used heart surgery drug Trasylol before an advisory panel met and ruled that the side effects were acceptable, the company said.

The Food and Drug Administration said the early findings from a new review of hospital records from 67,000 patients suggested that Trasylol use might increase the chances of death, serious kidney damage, congestive heart failure and strokes.

The FDA said it was reviewing the data to decide how they would affect current advice to limit Trasylol use to cases in which doctors believe that reducing blood loss during bypass surgery is essential and outweighs possible risks.

Bayer said it did not share the information with the FDA immediately because there were questions about the study’s methodology and the findings were preliminary.

From Reuters

* Eli Lilly & Co. said it was uncertain whether it would conduct a new, years-long clinical trial on an experimental drug for diabetes-related blindness requested by the FDA to approve the medicine. Lilly said it was disappointed with the FDA’s request and was weighing whether to conduct a new, three-year clinical trial for Arxxant.