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aprotonin |
| Trasylol |
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Pharmaceutical
company:
Bayer Pharmaceuticals www.bayer.com |
NEW WARNING
The Food and Drug Administration (FDA) has issued a followup statement regarding Bayer’s systemic hemostatic drug aprotonin (Trasylol). The Drug Safety Monitoring Board reported to the FDA that a drug study involving aprotonin was stopped when preliminary results seemed to indicate an increase in mortality and hemorrhage in the patient group receiving aprotonin. The FDA will reevaluate the overall risks and benefits of the drug and then take further action. The FDA is advising all providers who consider using aprotonin to be aware of the possible increased risks associated with use of the drug. All providers are urged to report any serious or unexpected adverse reactions to Bayer or to MedWatch.
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