Bayer of Germany says that it is terminating three studies to expand use of Trasylol, which is currently the only drug approved to reduce blood loss during coronary artery bypass surgery.
The Leverkusen-based group will end the studies investigating the safety and efficacy of Trasylol (aprotinin) on transfusion requirements and blood loss in adults undergoing elective spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and radical or total cystectomy in bladder cancer.
The studies are being pulled in response to a recent change to the US labelling for the drug which states that Trasylol should be administered only in surgical settings where cardiopulmonary bypass (CPB) can be rapidly initiated, and Bayer says that “the use of CPB is not practical in non-cardiac surgical settings.” The drug’s labelling is currently under review in Europe.
The company also stressed that the decision was not based on any safety findings in these non-coronary artery bypass graft surgery studies and cited a report from a data monitoring panel in November said the trials, which had involved 120 patients “could continue as planned without modification."
Trasylol has proved to be somewhat problematic for Bayer of late. Last year, the US Food and Drug Administration began reassessing the safety of the drug, when two separate studies suggested links to heart attack, stroke and kidney problems. In September, Bayer submitted new data to the FDA about risks of Trasylol but crucially this came days after advisory panel meeting was held to review the drug's labelling and found it to be safe and effective. Bayer admitted that it should have disclosed the results earlier and suspended two senior staff members as a result of the incident.
Bayer settles with 30 US states over Baycol
Meantime, Bayer has reached an $8 million settlement agreement with 30 US states regarding allegations that the it failed to adequately warn consumers about risks associated with its cholesterol-lowering drug, Baycol (cerivastatin), which was withdrawn from the market in 2001.
Bayer informed the FDA about the drug's elevated risks but was being accused of not sufficiently warning consumers or physicians about potential problems, including a severe and potentially fatal muscle reaction that could cause kidney failure. Bayer doers not admit any wrongdoing but has agreed to register relevant clinical drug trials and study results online.
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