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 reports to the Medical Products Agency. The spectrum of adverse symptoms was 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-Barré syndrome was found. The estimated frequency of the zimeldine-induced hypersensitivity syndrome (HSS), comprising fever, myalgia and/or arthralgia and signs of liver function disturbance, ranged from 1.4% to 13% in the inquiry and from 0.63% to 3.4% in the report part of the study. Adverse experiences usually had a considerably higher incidence during the first 6 weeks of zimeldine treatment than thereafter. This is in agreement with the clinical experience that most of the adverse reactions occur early during zimeldine treatment. However, a number of adverse experiences did occur with a later onset. This may justify a prolongation of the compulsory 4 weeks' testing of liver function that is required during licensed treatment. There were significantly fewer patients who developed fever among the patients who had experienced previous zimeldine treatment than among those who had not. Otherwise there was no statistically significant difference in frequency of adverse symptoms between these two groups. Consequently zimeldine treatment per se does not seem to predispose to development of an HSS or other types of adverse reactions during subsequent therapy.
The aim of this study has been to explore and compare the mortality of 100 female and 100 male alcoholics, admitted to a department of alcoholic diseases in 1963-69. The patients were early cases and mortality was studied during an observation period of 6-12 years. A total of 18 women and 16 men died. As compared with the general population, mortality was 5.6 and 3.0 times higher than expected for the women and men, respectively. Among the women a significant excess mortality was found for accidents, suicides, diseases of the respiratory system, and especially cirrhosis of the liver. Mortality among the men was significantly higher than expected due to suicides, diseases of the circulatory system, neoplasms, chronic alcoholism, and acute alcohol poisoning. The excess mortality from suicides found for both sexes was highest in the female group. Despite the hitherto rather small number of deaths in the two groups, the high frequency of cirrhosis of the liver among the women is striking.
The aim of this study has been to describe the different ways in which 100 alcoholics of each sex sought treatment, with special reference to the females. In addition, some psychiatric and social characteristics of the two groups of patients are presented. A significantly higher number of the females were admitted as a result of an acute complication: unconsciousness, suicide attempt, confusion, neurological disorders, etc., while the males generally sought treatment under less dramatic circumstances. As the patients selected were early cases, most had not been treated before, but in those with previous in-patient psychiatric treatment a diagnosis without an alcohol connection was significantly more common among the women. Drug abuse was considerably more frequent among the female as compared with the male alcoholics, and the specific lonely drinking pattern was also more common among the women. A striking difference between the sexes appeared with respect to partner: more than one-half of the married women had alcoholic husbands. The corresponding figure for the married men amounted to about 10%.
We describe a case of severe cholestatic liver disease, which persisted for 7 years, and was probably induced by flucloxacillin. We also report a survey of 77 liver reactions which were probably or possibly induced by penicillinase-resistant penicillins and spontaneously reported to the Swedish Adverse Drug Reactions Advisory Committee. The reactions were usually cholestatic with a tendency to a protracted course. There is some evidence for an immunoallergic idiosyncratic reaction. The incidence of reported liver reactions was estimated from sales data to be 1.6-2.9 per million DDD (defined daily doses) or, for flucloxacillin 1:11,000-1:30,000 prescriptions. Female sex, age and high daily doses seemed to be associated with higher risk of liver reactions from flucloxacillin.
Since the withdrawal of phenformin in 1978, the use of metformin has increased from 13,500 to 22,000 patient years/year. During the period 1977-91 a total of 18 cases of metformin-associated acidosis was reported, of which 16 had lactic acidosis. The incidence of reported acidosis and lactic acidosis decreased from 1.50 cases per 10,000 patient years in 1977-81 to 0.24 cases per 10,000 patient years 1987-91, probably due to lower doses doses and reduced usage in the very old. All the reports described patients with several other concomitant diseases, mainly cardiovascular and renal, when the acidosis was diagnosed. It is important continuously to re-evaluate metformin therapy and to stop treatment at the onset of impaired renal or cardiovascular function.
During the period February 1983 to December 1984 the Swedish Adverse Drug Reactions Advisory Committee received 80 reports describing 116 adverse reactions with a possible or probable connection to nifedipine. The most frequently reported reactions are oedema, tachycardia, headache and rash. Confusion and sleep disorders constitute 8 cases. Impaired angina is a potentially serious reaction and one patient developed myocardial infarction.