Spontaneous Reporting System SRS

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 ... 

In the past, the FDA (1995) itself has been vocal about the limits of premarketing testing and about the importance of the supposedly less scientific postmarketing spontaneous reporting system (SRS) in which... 

In describing the impact of the MedWatch spontaneous reporting system (SRS), the FDA s Kessler (1993) said ... 

The reports were sent to the FDA through its postmarketing spontaneous reporting system (SRS). The FDA representative projected the data onto a screen, but the data were not included in the transcript of the meeting. Although this issue was of overriding, central importance to its deliberations, the FDA advisory panel made no response at all to it. It was as if the data, so critical to their conclusions, had been presented to an empty room. 

The FDA s Spontaneous Reporting System (SRS) was in operation from 1968 to October 1997. The reports were transitioned to the AERS, which has been used from October 1997 to the present. A publicly released version can be purchased on a quarterly basis. It is a passive surveillance system where direct volunteer reporting accounts for 10% of reports from healthcare professionals and consumers. Ninety percent of reports in the FDA s postmarketing safety surveillance databases come from pharmaceutical companies, as they are mandated by regulations to report AEs that they receive. The combined SRS + AERS database currently contains more than 2.7 million reports and is growing rapidly, at about 465, 000 reports on an annual basis. The number of reports has more than doubled in the last 10 years and because the FDA is interested in serious, unlabeled reports, that has grown as a percentage of the total number of reports submitted to the FDA. 

FDA-SRS Spontaneous Reporting System of the Food and Drug Administration... 

From spontaneous reports alone, we cannot estimate the actual incidence of alprazolam-induced rage reactions. But in light of the widely acknowledged, substantial underreporting to spontaneous surveillance systems in general and to the FDA s SRS in particular, it is entirely possible that six reports of this kind of reaction within a single year might reflect sixty or more in reality. 

---