Toleration and safety of sertraline: experience worldwide

Abstract

The clinical trial programme of sertraline, a selective serotonin re-uptake inhibitor, has shown the drug to have a favourable safety and toleration profile. In contrast, the tricyclic antidepressant, amitriptyline, produced a significant level of side effects, particularly anticholinergic. The side-effect profile of sertraline was similar in young and old, and individual side effects did not make a notable contribution to the discontinuation rate. The incidence of side effects was related to both dosage and dosage regimen. An initial dose of 50 mg increased at 2-weekly intervals to 100 mg and then 200 mg daily produced a very low incidence, no side effect occurring with a frequency greater than 10%. In the long term (after 8 weeks' study), sertraline was well tolerated with little difference in side-effect reporting from placebo. There were no significant problems with safety. Sertraline was without effect on vital signs or electrocardiogram, and had no clinically relevant effects on laboratory values. In contrast to amitriptyline there was no significant effect on body weight. The overall incidence of mania was 0.4% and skin rash less than 2%. There were no cases of drug-related convulsions. Overdose with sertraline (four cases) was satisfactorily overcome with no significant sequelae and without the need for intensive monitoring.