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news.Bayer AG has reported that two of its employees have been suspended in the wake of the company's failure to disclose trial results of its bleeding prevention drug Trasylol to the FDA.
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The two employees suspended are senior members in Bayer’s Global Drug Safety Group in Germany.
Bayer also said that it has appointed an independent counsel to review the company’s actions in regards to disclosure of the preliminary results from the observational study on Trasylol.
Earlier in the year, the FDA began a review into Trasylol which was triggered by two published studies that reported serious side-effects of the drug including kidney problems and increased risk of heart attacks and stroke.
Bayer then admitted it had not revealed the findings of another study also pointing out the adverse effects of Trasylol. Bayer said it had mistakenly failed to disclose the data because it was preliminary in nature.
“Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21st Advisory Committee Meeting on Trasylol. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals,” commented Dr Roland Hartwig, General Counsel, Bayer.
The company also said it would publish the findings of the review when they are complete.