The tolerability of dothiepin: a review of clinical studies between 1963 and 1990 in over 13,000 depressed patients.
1. A total of 13,834 depressed patients were exposed to dothiepin most frequently at a dose of 150 mg/day and over 6 weeks, in 116 clinical studies between 1963 and 1990. 2. Overall, 2,066 (15%) patients were withdrawn prematurely from dothiepin for a variety of reasons, the most commonly specified reason being due to drug-related events in 500 (4%) patients. 3. In the remaining 11,768 patients, there were 9,312 reports of unwanted events most typically associated with the pharmacological effects of a tricyclic antidepressant although no serious sequelae were reported. 4. This review indicates that the incidence of serious adverse events associated with dothiepin at therapeutic doses is very low.
Research Department, Boots Pharmaceuticals, Nottingham, England.
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Donovan
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Dearden
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Richardson
D002986:Clinical Trials as Topic; D003866:Depressive Disorder / Q000150:complications* / Q000188:drug therapy / Q000401:mortality; D004308:Dothiepin / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans
D004308:Dothiepin