Evidence From the Food and Drug Administrations Spontaneous Reporting System

Evidence From the Food and Drug Administration s Spontaneous Reporting System 

In 1987, Bixler et al. reviewed adverse reactions to BZs recorded in the FDA s spontaneous reporting system (SRS). They compared triazolam with two other BZs commonly used to induce sleep temazepam (Restoril) and flurazepam (Dalmane). They controlled the reports for the number and size of prescriptions for each of the three drugs. In regard to psychiatric adverse reactions, they found  

The affective and other behavioral disturbances category of adverse drug reactions included Depression, Psychotic Depression, Emotional lability, Euphoria, Hostility, Personality disorder, and Decreased libido.  

Robert Bob Wise (1989), in a working paper for the FDA s Division of Epidemiology and Surveillance, made an executive summary concerning reports of hostility on triazolam. Wise addressed a syndrome that consists of anger or rage, aggression, and some actual assaults and murders. He stated  

More such reports of this type have been received by the FDA for triazolam and alprazolam than for any other drug product regulated by the Agency. Reporting rates, which adjust for differences in the extent of each drug s utilization, reveal much higher ratios of hostility reports to drug sales for both triazolam and alprazolam than for other benzodiazepines with similar indications. 

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