ADVERSE EXPERIENCES DURING TREATMENT WITH ZIMELDINE ON SPECIAL LICENSE IN SWEDEN

Adverse experiences during licensed treatment with the antidepressant serotonin (5-HT) reuptake inhibitor zimeldine in Sweden are presented. Data were obtained from a written inquiry of 694 patients and 67 repo rts to the Medical Products Agency. The spectrum of adverse symptoms w as in agreement with those reported in previous studies on zimeldine. The most frequent adverse experiences were headache, nausea, myalgia, signs of liver function disturbance, arthralgia, neurological symptoms , fever and insomnia. No new case of the Guillain-Barre syndrome was f ound. The estimated frequency of the zimeldine-induced hypersensitivit y syndrome (HSS), comprising fever, myalgia and/or arthralgia and sign s of liver function disturbance, ranged from 1.4% to 13% in the inquir y and from 0.63% to 3.4% in the report part of the study. Adverse expe riences usually had a considerably higher incidence during the first 6 weeks of zimeldine treatment than thereafter. This is in agreement wi th the clinical experience that most of the adverse reactions occur ea rly during zimeldine treatment. However, a number of adverse experienc es did occur with a later onset. This may justify a prolongation of th e compulsory 4 weeks' testing of liver function that is required durin g licensed treatment. There were significantly fewer patients who deve loped fever among the patients who had experienced previous zimeldine treatment than among those who had not. Otherwise there was no statist ically significant difference in frequency of adverse symptoms between these two groups. Consequently zimeldine treatment per se does not se em to predispose to development of an HSS or other types of adverse re actions during subsequent therapy.