Bayer has revealed that two employees have been suspended in connection with the company’s failure to disclose data about the risks of Trasylol (aprotinin), used to reduce blood loss during heart surgery.
Bayer recently admitted that it failed to keep the US Food and Drug Administration informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of Trasylol, and whether its use increased the risk of kidney problems, heart attacks and strokes. The FDA panel had concluded that Trasylol was safe and effective but, after seeing the new data, issued a warning on the product.
Speaking at the company’s autumn press conference in Leverkusen, Bayer chairman Werner Wenning confirmed that two members of staff in Germany had been suspended and a US lawyer has been called in to examine the case.
The Trasylol situation is “something we regret very much,” Mr Wenning said, although he told PharmaTimes World News that relations with the FDA have not been damaged and further discussions are taking place with the agency. He insisted that the drug was a safe and effective treatment, and reiterated the point that the data had not been shared immediately because of its preliminary nature.
The effect on third-quarter sales of Trasylol was considerable, as they fell some 40% on the like, year-earlier period to 38 million euros.