PubMed Health⌕ Search

Biomedical subjects

B E Wiholm

Publications and source records attributed to B E Wiholm.

14 recordsLinked to original sources
PubMed1992

Effects of exposure to benzodiazepine during fetal life.

Dysmorphism and mental retardation have been reported in 7 Swedish children born of mothers who had taken high doses of benzodiazepines regularly during pregnancy. To explore this association further, we examined benzodiazepine use during pregnancy in 104,000 women whose deliveries were registered by the US public health insurance system, Medicaid, during 1980-83. Fetal outcomes were assessed from the health claims profiles of their offspring, up to 6-9 years after delivery. 80 pregnant women had received 10 or more benzodiazepine prescriptions during the 4 years. Their records showed heavy general use of health care and frequent alcohol and substance abuse, and other disorders that could confound any effect of the benzodiazepines. For the 80 pregnancies, 3 intrauterine deaths were identified as well as 2 infants with congenital abnormalities whose curtailed records suggested neonatal death. Records of 64 surviving children could be linked to these 80 pregnancies whilst records for 11 apparent survivors could not be located. 6 of the 64 survivors had diagnoses consistent with teratogenic abnormalities. The high rate of teratogenicity after heavy maternal benzodiazepine use occurs with multiple alcohol and substance exposure and thus may not be due to benzodiazepine exposure.

Abnormalities, Drug-Induced↗
PubMed1992

Angio-oedema in relation to treatment with angiotensin converting enzyme inhibitors.

OBJECTIVE: To evaluate and describe the clinical course of angio-oedema reactions induced by angiotensin converting enzyme inhibitors. DESIGN AND METHODS: All reports of angio-oedema reactions associated with angiotensin converting enzyme inhibitors submitted to Swedish Adverse Reactions Advisory Committee were reviewed and the clinical courses summarised. Numbers of cases judged to be induced by angiotensin converting enzyme inhibitors were related to their annual usage, estimated from total sales of defined daily doses, as well as to the estimated number of new patients. All cases of angio-oedema associated with angiotensin converting enzyme inhibitors reported to the World Health Organisation's international drug information system were also summarised. RESULTS: 36 of the 38 reported cases in Sweden between 1981 and 1990 were judged to be related to angiotensin converting enzyme inhibitors. During 1981 through 1990, altogether 1309 cases of angio-oedema associated with angiotensin converting enzyme inhibitors were registered with the international drug information system. The incidence of reported cases of angio-oedema increased largely in parallel with the increased sales (usage) of angiotensin converting enzyme inhibitors. Of the 36 Swedish patients, 77% experienced the reaction within the first three weeks after starting treatment. 10 patients needed hospitalisation, two of whom had life threatening laryngeal obstruction. With one exception all 36 patients were free of symptoms within one week after discontinuing the drug. CONCLUSIONS: Angio-oedema induced by angiotensin converting enzyme inhibitors is a rare but potentially life threatening reaction, which in most instances occurs shortly after the start of treatment. Any patient in whom the reaction is suspected should have the treatment interrupted and, if necessary, be admitted for observation.

Adult↗
PubMed1992

Comparing risk estimates of sulphonamide-induced agranulocytosis from the Swedish Drug Monitoring System and a case-control study.

A comparison has been made of risk estimates for agranulocytosis connected with sulphasalazine and trimethoprim-sulphamethoxazole (T-SM) therapy calculated from data in the Swedish Drug Monitoring System ("spontaneous" reports, sales and prescription information) and a population based case-control study (the IAAAS). The relative risk for agranulocytosis during sulphasalazine treatment was calculated to be 107 and 123 by the spontaneous reporting system and the case-control study, respectively. The corresponding excess risk in both systems was 1.8. For T-SM the relative risk was 17 in the spontaneous reporting system and 12 in the case-control study, while the excess risk calculated for 3 days of treatment was 0.9 in the spontaneous reporting system, and 1.6 for 3 or more days of treatment in the case-control study. It is concluded that the Swedish Drug Monitoring System gives an appropriate estimate of the risk of developing agranulocytosis in association with the two drugs studied.

Adolescent↗
PubMed1992

Liver damage from flucloxacillin, cloxacillin and dicloxacillin.

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.

Chemical and Drug Induced Liver Injury↗
PubMed1991

Evaluation of a prescription based record-linkage model for epidemiological studies of long-term adverse effects of drugs--with special regard to combined oral contraceptives.

The Department of Drugs of the Swedish National Board of Health and Welfare undertook a study of the possibilities of a new scheme for post-marketing surveillance by means of prescription and register based epidemiological studies, primarily of combined oral contraceptives (COC). Based on available data on COC usage patterns and incidence rates of the disease at study, it was estimated that study periods, including the necessary time periods for disease development and generation of a sufficient number of cases, would amount to at least 1 to 13 years for cardiovascular outcomes and 8 to 17 years for reproductive cancers. Prospective and unbiased exposure ascertainment would be the most important advantage. However, delay in follow up, the need for extensive individual questionnaire probing and fear of violation of personal integrity could adversely affect the feasibility of the scheme. Chiefly on the grounds of the extended study periods and magnitude of the necessary infrastructure, it was not judged cost-effective to pursue such a scheme for COC exposure only. It was, however, suggested that it would be considered for epidemiological surveillance of other drugs that are commonly used and for which short term and frequent serious side effects are expected, as for instance lipid lowering compounds, beta-blockers, bensodiazepines and other psychotropic drugs.

Adult↗
PubMed1991

Severe hypoglycaemia during treatment with glipizide.

In the years 1980-87, 19 cases of severe hypoglycaemia during treatment of Type 2 diabetes with glipizide were reported to the Swedish Adverse Drug Reactions Advisory Committee. Patient age was 75 +/- 9 years (mean +/- SD) (significantly higher than in all patients on glipizide in Sweden), and the duration of glipizide treatment ranged from 1 day to 4 years. Eleven patients presented with coma, three with reduced consciousness and five with other symptoms. An uneventful early recovery occurred in 14 patients. The remaining five patients had prolonged or recurrent hypoglycaemia for up to 60 h. Two of the patients, both with complicating disorders, died. In a case-control substudy, patients with glipizide-associated hypoglycaemia were found to have renal impairment more often than age- and sex-matched controls treated with glipizide (odds ratio 4.0). The median dose of glipizide (10 mg per day) was identical to that in controls. Other drugs, notably diuretics and benzodiazepines, were more commonly used by hypoglycaemic patients (median 5 vs 2 concomitant drugs, p less than 0.001). We conclude that the use of glipizide is associated with a risk of developing severe hypoglycaemia with a clinical course that is not always benign.

Aged↗
PubMed1990

Quality criteria for early signals of possible adverse drug reactions.

The main function of the World Health Organisation's International Collaborative Programme on Drug Monitoring is to provide a reliable early warning of possible health hazards caused by medicines. Described here is an attempt to devise criteria that would produce a well-founded early signal of an adverse reaction on the basis of reports sent in by national collaborating centres and combined in the WHO database. To reduce the frequency of spurious associations (false-positive signals) it is suggested that publication be delayed until a few case-histories meeting the suggested criteria have been sent in. The criteria were tested retrospectively against early published case-reports on drug-associated agranulocytosis. 19 suspected associations were examined and a signal in the database was defined by there being three or more cases containing stipulated information about the patient and the treatment. The WHO database had reports on all the associations, suggested criteria for a signal being met in 15 instances. This signal was present when the first case was published in 7 instances and within three months of first publication in 1. Moreover, in 3 instances where publication came first the cases presented had been collected by a national drug monitoring centre. The WHO databank has the potential to provide doctors and scientists with signals which then should be evaluated in detail.

Agranulocytosis↗
PubMed1978

Epidemiology of adverse drug reactions to phenformin and metformin.

Adverse drug reactions (ADRs) to phenformin and metformin reported to the Swedish Adverse Drug Reaction Committee during 1965--77 were analysed in relation to sales and prescription data. The biguanides accounted for 0.6% of all reported adverse drug reactions but for 6% of the fatal cases (all phenformin). Sixty-four ADRs to phenformin and eight to metformin were classified as causal relation "probable" or "not excluded." Fifty-one of these reactions (71%) were lactic acidosis, all but one being reactions to phenformin. After 1973 phenformin was prescribed less in Sweden and metformin became predominant. A nationwide prescription survey during 1975--6 disclosed no differences in age and sex between patients receiving phenformin and metformin. The mean daily doses prescribed in 1976 were 74 mg of phenformin and 1.5 g of metformin. The numbers of ADRs to the two drugs reported during 1975--7 were related to use. The relative incidences of ADRs reported for phenformin and metformin did not differ. Significantly more cases of lactic acidosis and deaths were reported for phenformin.

Acidosis↗