Diclofenac-induced isolated myonecrosis and the Nicolau syndrome.
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Adult↗
Biomedical subjects
B H Stricker
Publications and source records attributed to B H Stricker.
[Loss of taste sensation in terbinafine administration].
Terbinafine is a new antifungal agent for oral treatment of dermatomycosis. Seven patients are reported who developed taste loss after treatment with terbinafine. In four of them, taste loss was complete while one patient was still able to taste sweet products, and a second and third patient no longer tasted salty and sweet products, respectively. In all patients, the onset of the adverse reaction occurred 4-8 weeks after starting treatment. As far as known, taste loss is a transient effect which disappears within 3-6 weeks after discontinuation of terbinafine.
Adult↗
[Fever caused by neuroleptics].
If fever arises in patients using neuroleptic drugs, it is possible that the fever is an adverse reaction to the drug. Two cases are reported of patients who developed fever to neuroleptic agents. In one patient it probably concerned a reaction to the solvent of the sustained-action preparation of the drug. The other patient developed fever probably as part of the neuroleptic malignant syndrome.
Adult↗
Loss of taste and terbinafine.
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Antifungal Agents↗
[Chest pain due to sumatriptan].
Since the registration of sumatriptan (Imigran) in May 1991, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 13 reports of substernal chest tightness or pain attributed to its use. These concerned 11 women and two men with an average age of 41 years, who developed angina-like symptoms mostly within one hour after oral or subcutaneous administration. Electrocardiography (in three patients) and echocardiography (in one patient), performed after resolution of the symptoms, were normal. With the exception of one patient, none had experienced such symptoms before. Although sumatriptan is an effective anti-migrainous drug, cautious use is strongly advised. Sumatriptan is contraindicated in patients with coronary artery disease or variant angina pectoris.
Adult↗
Hepatic injury associated with itraconazole.
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Aged↗
Coronary vasospasm and sumatriptan.
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Administration, Oral↗
[Serious psychological side effect in children taking high doses of deptropine].
Since 1986 the Netherlands Centre for Monitoring of Adverse Reactions to Drugs has received 16 reports concerning psychic effects attributed to the use of deptropine citrate (Brontine) in children ranging from one to ten years of age. Within 1 to 3 days after starting treatment with a daily dose of 0.6-3 mg, hallucinations appeared in 7 children, aggressive behaviour and/or agitation in 6 children, ataxia in 2 children, and anxiety in 1 child. In none of these cases could another cause be found. In one patient symptoms persisted during the whole 15-month period of treatment. All patients recovered rapidly after discontinuation of deptropine citrate. As it probably concerns a dose-dependent effect and because most patients had been prescribed a daily dose of 0.06 mg/kg body weight, it is strongly advised to exceed the recommended daily dose of 0.03 mg/kg body weight as little as possible.
Aggression↗
[Post-asphyctic encephalopathy of the neonate following administration of nalbuphine during childbirth].
After an intramuscular injection of nalbuphine during parturition a foetal bradycardia of 30-40 beats/minute developed, which normalised after an intravenous maternal injection of naloxone. Because the cardiotocography did not show variability after the event, a caesarean section was performed. Six months later the child still had a severe neurological disorder which was attributed to intrauterine asphyxia. Several authors published reports in which no relevant clinical problems were described after nalbuphine given during labour. Recently, however, four children have been described with bradycardia and respiratory depression after maternal intravenous and/or intramuscular injection of nalbuphine. Apparently, the use of nalbuphine during labour can cause foetal bradycardia, both after intravenous and after intramuscular administration. Great reserve is advised regarding use of nalbuphine for this indication. The antidote naloxone should be within reach.
Adult↗
Acitretin (Neotigason). A review of pharmacokinetics and teratogenicity and hypothesis on metabolic pathways.
Acitretin was introduced as a replacement for etretinate, the ethyl ester of acitretin. Acitretin is eliminated at a much faster rate than etretinate. Although both drugs are teratogens, the replacement was important especially as it allowed for a much shorter post-medication period in which pregnancy should be precluded. Recent findings showed the presence of etretinate in the plasma of acitretin-treated patients. This article gives a review of known metabolic pathways of the retinoids and tries to elucidate the possible conversion of acitretin into etretinate after acitretin ingestion.
Abnormalities, Drug-Induced↗
[Polymorph ventricular tachycardia with torsades de pointes caused by administration of terodiline (Mictrol)].
A 63-year-old female was admitted to the hospital because of collapse. She had no history of cardiovascular disease. Prior to admission she used co-trimoxazole, paracetamol, calcium tablets and 50 mg terodiline (Mictrol) daily because of bladder instability. Electrocardiography showed QT prolongation and polymorphous ventricular tachycardia with torsades de pointes. During admission she developed ventricular fibrillation, needing defibrillation. After withdrawal of terodiline and treatment with isoprenaline the symptoms and all ECG abnormalities disappeared. In this case terodiline was suspected of having been the causative agent. Terodiline shows structural resemblance to the anti-arrhythmic agent prenylamine, a known cause of torsades de pointes. Recently terodiline has been temporarily withdrawn from the worldwide market in order to investigate the causal relationship between this drug and cardiac arrhythmia and conduction disturbances.
Butylamines↗
Ad hoc tracing of a cohort of patients exposed to acitretine (Neotigason) on a nation-wide scale.
Etretinate has been detected in the blood of women taking acitretine. Because of the proven teratogenic effects of etretinate it was decided to try to trace all users of acitretine in The Netherlands via all drug dispensing outlets (1450 community pharmacies, 95 hospital pharmacies and 636 general practitioners). A request for information on the date of birth, sex, type of prescriber, and the number of capsules dispensed yielded a response rate of 87%. In 61% of all the responding dispensing outlets a prescription for acitretine had been filled. Of these 1153 outlets, 40% had dispensed acitretine to one patient and 52% had dispensed it to 2-5 patients. The 2717 patients comprised 1500 men (55%) and 1217 women, with mean ages of 48 and 53 y, respectively. As against 45% of all the male users, 31% of all the women were in the child-bearing age (15-45 y). The average numbers of dispensed capsules was 167 to users of 10 mg capsules, and 107 to users of the 25 mg capsules. In more than 80% of cases acitretine had been prescribed by dermatologists. Because the large majority of inhabitants in The Netherlands use one community pharmacy, and because most of them have automated records, it is possible to trace a cohort of users quickly and almost completely. Because most large-scale problems with adverse reactions are discovered within the first 2 years of marketing, at a time when exposure and morbidity registries are still collecting information, ad hoc formation of a cohort in this way may be a useful resource for postmarketing surveillance.
Acitretin↗
Serum sickness-like reactions to cefaclor.
In this study, we evaluated whether the high number of reports of serum sickness to cefaclor was present in every country and year, and whether these figures from voluntary reporting facilitated an estimation of the relative risk. A nested case-control study was performed with reports of all suspected adverse reactions (ADR) to cefaclor, amoxicillin and cephalexin in the period 1968-1987, as reported to the WHO Collaborating Center for International Drug Monitoring from the U.S.A., the U.K., Sweden, Canada and Germany. The ADR-reporting odds ratio was defined as the ratio of the odds of the number of ADR-reports of serum sickness to cefaclor and amoxicillin or cephalexin and the odds of similar reports of non-serum sickness to cefaclor and amoxicillin or cephalexin. The ADR-reporting odds ratio adjusted for country, age, gender, origin of the report and year of marketing was 12.4 for cefaclor vs amoxicillin and 18.5 for cefaclor vs cephalexin. In children (< 15 years of age) and in adults (> 15 years of age), the relative risk of developing serum sickness of cefaclor vs amoxicillin was estimated at 13.9 (95% confidence interval (95% CI): 6.0-32.2) and 2.9 (95% CI: 0.9-9.4) respectively in the U.S.A., and at 15.1 (95% CI: 7.2-31.5) and 5.5 (95% CI: 2.0-15.0) respectively in the other four countries together. In this study, the ADR-reporting odds ratio facilitated a valid estimation of the relative risk.
Adolescent↗
Pharmaco-morbidity linkage: a feasibility study comparing morbidity in two pharmacy based exposure cohorts.
STUDY OBJECTIVES: The aims were (1) to compare discharge diagnoses and concurrent medication in a pharmacy based cohort of users of H2 receptor antagonists to those in a population of users of other drugs in the same period, who did not use H2 receptor antagonists; (2) to compare these results to those of a similar study performed with the Tayside record linkage scheme. DESIGN AND SETTING: The study was a retrospective cohort study. The morbidity data from the only hospital in one medium sized city (62,000 inhabitants) were linked to the dispensing data of all five community pharmacies on an individual basis (April 1, 1986-December 31, 1989). In the absence of a unique patient identification number, data from pharmacies and hospital were linked by the combination of date of birth, gender, and general practitioner code. For every user of H2 receptor antagonists two controls were obtained from all patients who had not used these drugs, and matched for age (within 5 years), gender, and general practitioner. All discharge diagnoses which followed this first prescription up to December 31, 1989, in a patient in the index cohort, and during the same period in his or her matched controls, were included in the study. MAIN RESULTS: In the index cohort (n = 2174) 341 persons were admitted (526 admissions) as against 398 persons (527 admissions) in the control cohort (n = 4348). There was increased morbidity in the index cohort, especially concerning the gastrointestinal system (peptic ulcers and malignancies, abdominal pain, gastrointestinal haemorrhage), but also concerning the musculoskeletal, respiratory, and circulatory systems. The morbidity in the last three groups corresponded with drugs used concomitantly by patients in the index cohort, so it was probably not causally related to the intake of H2 receptor antagonists but was rather an indicator of higher levels of morbidity in the index cohort. CONCLUSIONS: The figures were grossly comparable to those of the Tayside record linkage scheme. Probabilistic linking with the patient characteristics of gender, date of birth, and general practitioner code can facilitate the undertaking of postmarketing surveillance studies.
Chronic Disease↗
Channelling of controlled release formulation of ketoprofen (Oscorel) in patients with history of gastrointestinal problems.
STUDY OBJECTIVE: The aim was to determine if a new controlled release formulation (Oscorel) of the non-steroidal anti-inflammatory drug (NSAID) ketoprofen has been preferentially prescribed in patients with prior history of gastro-intestinal disturbances. DESIGN: The study was a pharmacy records based comparison of the rates of prior prescribing of drugs indicated for peptic ulcer treatment in first recipients of Oscorel in 1989 versus recipients of other NSAID products. SETTING: A representative panel of Dutch community pharmacies serving approximately 425,000 people was used. MAIN RESULTS: Oscorel was launched in January 1989. Data on prescriptions dispensed in 1987-1988 to a total of 837 first users of Oscorel were analysed and compared with the dispensing history of a reference population including 30,787 patients who did not receive a prescription for Oscorel during 1989. Compared to the reference population, first users of Oscorel included a greater proportion of females, of patients 75 years and older, of heavy users of NSAIDs, and of patients switching among different NSAIDs. A total of 24.1% of first users of Oscorel had received peptic ulcer therapy in 1987-1988, versus 15.7% of the reference population. The rate ratio was 1.54, with 95% confidence interval of 1.36-1.74. Adjustment for stratifying variables caused only minor changes in the rate ratio, which remained stable on 1.5. CONCLUSIONS: Oscorel appears to have been channelled into use in patients with recognised risk factors for gastrointestinal toxicity. This preferential prescribing probably resulted from expectations and claims that this product has a lower risk of such toxicity.
Community Pharmacy Services↗
[Toxic damage of kidney, liver and muscle attributed to the administration of germanium-lactate-citrate].
The case history is described of a woman aged 57 years with renal, hepatic and muscular damage attributed to intake of germanium lactate-citrate (a cumulative dose of 32.1 g germanium) over at least one year, as alternative treatment of metastatic breast cancer. Histological examination of biopsies showed highly vacuolated cytoplasm of the epithelial cells of the distal renal tubules and micro- and macrovesicular steatosis of centrilobular hepatocytes. After discontinuation of the germanium, serum aminotransferases and creatine kinase values returned to normal, but moderately severe renal impairment persisted.
Breast Neoplasms↗
[Fatal liver cell necrosis following administration of glafenine].
The case is described of a patient with fulminant hepatic failure attributed to intake of glafenine 400 mg daily for 15 days. The first symptoms appeared two weeks after discontinuation of glafenine. Other causes of hepatic necrosis could be excluded. Approximately five weeks after the onset of symptoms the patient died of hepatic failure. At autopsy massive hepatic necrosis and massive pancreatic necrosis were demonstrated.
Aged↗