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Study of reasons for cessation of therapy with perhexiline maleate, sodium valproate and labetalol in the intensified adverse reaction reporting scheme.

A questionnaire was distributed to doctors requesting reasons for cessation of therapy in patients on three drugs being intensively monitored. Adverse events were given as the reason in 20 percent of patients stopping treatment with perhexiline, 15 percent with sodium valproate and 43 percent with labetalol. These adverse events are listed and compared with those reported spontaneously to the medical assessor for the same period. Deaths reported do not appear to be drug related. Enquiry concerning reasons for cessation of therapy would appear to be a useful adjunct to spontaneous reporting of adverse events for drugs being monitored intensively. The number of additional adverse events derived from the questionnaires approximately equalled those from spontaneous reporting.