Leverkusen - Chemicals and pharmaceuticals giant Bayer has to be employed in heart surgery drug Trasylol vomMarkt take the time being.
The Federal Institute for Drugs and Medical Devices ordered on Monday due to a potentially erhöhtenSterblichkeitsrisikos suspension of the authorization. Trasylol may now not be sold, the doctors were asked to apply more esnicht. In Canada, a clinical study had been zuTrasylol canceled for security reasons.
Bayer announced that the marketing suspension of Trasylol vorübergehendweltweit. With this decision, we follow the Anordnungdes Federal Institute and the recommendations of the U.S. GesundheitsbehördeFDA and other regulatory authorities, told the group.
DieAussetzung marketing applies until endgültigenErgebnisse the applicant relied on the study and were analyzed. EineZwischenanalyse had an increase in total mortality shown In comparison to two other drugs.
Trasylol is used to zuverringern bleeding during cardiac surgery. With the drug, Bayer has implemented in the first nine months of this year indicated that after 93 million euros, davonetwa 63 million euros in the U.S.. Bayer continues to believe that Trasylol `a positive cost-benefit profile mentions. Daserhöhte risk of death lies at the margin of statistical significance.
For Bayer, the suspension of Trasylol marketing zweiteRückschlag in the pharmaceutical sector within a few days. In dervergangenen week group had indicated that due neuerStudienergebnisse not ask applicants for higher Dosierungseines Multiple Sclerosis Using Betaferon. Bayer hatdeshalb in the third quarter write-downs Eurovorgenommen of 152 million.
