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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 163 records · Page 9Linked to original sources

[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 Recently terodiline has been temporarily withdrawn from the worldwide market in order to investigate the causal relationship between this drug and cardiac arrhythmia and conduction disturbances.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↗

[Acitretin; an example of ad-hoc tracing of users in acute problems with drugs].

Recently etretinate was demonstrated in the blood of women on acitretin. Because of the proven teratogenic effects of etretinate we tried to trace all users of acitretin in the Netherlands via all drug dispensing outlets (1450 community pharmacies, 95 hospital pharmacies and 636 general practitioners). A request for information as regards date of birth, sex, type of prescriber, and number of dispensed capsules was followed by a response rate of 87%. In 61% of all responding outlets a prescription of acitretin had been filled. Of these 1153 outlets 40% had dispensed the drug to one user, whereas 52% had dispensed acitretin to 2-5 patients. The 2717 patients consisted of 1500 men (55%) and 1217 women with mean ages of 48 and 53 years, respectively. Of the women 31% were in the age-group of 15-45 years and of the male users, 45% (p less than 0.0001), whereas in other age groups there was no difference. In 80% of cases acitretin had been prescribed by dermatologists. This study demonstrated that it is possible to trace a cohort of users quickly and almost completely. As most large-scale problems with adverse reactions are discovered in the first 2 years of marketing when exposure and morbidity registries are still collecting information, ad hoc cohort formation may be a useful resource for postmarketing surveillance.

Acitretin↗

[Angioedema caused by enalapril].

Since 1984 25 cases of enalapril induced angioedema have been reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs. Two patients with enalapril induced angioedema are described. The pathophysiological mechanism of this potentially life-threatening adverse effect is probably not a direct allergic response to the drug itself. Enalapril inhibits angiotensin converting enzyme, which not only metabolizes angiotensin I but also bradykinin and 'substance P'. Bradykinin and 'substance PH may then accumulate and cause angioedema in a direct or indirect way. It is of great importance that instances of oropharyngeal swelling are considered a possible result of an adverse reaction to ACE-inhibitors.

Adult↗

Glafenine-associated anaphylaxis as a cause of hospital admission in The Netherlands.

In 1981 generalized anaphylaxis was registered on 166 occasions in Dutch general and academic hospitals. Clinical details of 120 of those patients revealed that in 107 anaphylaxis was either probable (n = 90) or possible (n = 17), whereas in 13 cases some other reaction than anaphylaxis had occurred. The series of confirmed cases contained 46 men and 61 women, with mean ages of 47 y and 48 y, respectively. There was a complete recovery in 102 patients and two patients died. Hypotension was present in 79 cases (74%), dyspnoea in 34 cases (32%) and a skin reaction, mainly urticaria, erythema or angioedema, was mentioned in 62 cases (58%). Most cases of anaphylaxis were drug-induced (76%), the main causes being the analgesic glafenine and contrast media. Glafenine was mentioned as the cause in 36% of all admissions for drug-induced anaphylaxis. Only 3.7% of cases had been reported to the voluntary reporting scheme of the Netherlands Centre for Monitoring of Adverse Reactions to Drugs. On the basis of reimbursement data, the risk of developing severe anaphylaxis to glafenine was estimated at 11.7-19.3-fold relative to indomethacin, and 13.4-20.2-fold relative to oral penicillins.

Adolescent↗

[Pharmaco-morbidity linking: a pilot study of its technical possibilities in The Netherlands].

The feasibility has been studied of linking pharmacy-based dispensing data and hospital-based morbidity data by using as a linkage key a combination of gender and birth date of the patient and of his general practitioner (GP) code. Firstly, the records of one pharmacy (14,686 patients) and those of one hospital (8475 admissions in 1987) were linked on the basis of date of birth and gender. This resulted in 3,715 matching record pairs. To a random sample of 1,713 of these pairs the GP code was added. Subsequently these pairs were validated by reference to the original medical and pharmaceutical records with a procedure that guaranteed that only the name and address of the patients could be compared without having access to the clinical or pharmaceutical record of an individual. We were able to link records with a sensitivity of 91.4% (95%-confidence interval: 88.8-94.0) and a specificity of 96.0% (95%-confidence interval: 94.5-97.5). In conclusion, probabilistic linkage of pharmaceutical and medical data with the combination of gender, date of birth and GP code facilitates successful record linkage.

Drug Therapy↗

[Inefficacy of oral contraception during use of minocycline].

A healthy woman aged 21 years who used the oral contraceptive Trigynon became pregnant while being treated with Minocin (minocycline; 100 mg per day) for acne conglobata. While the risk of use of antibiotics such as this one reducing the efficacy of oral contraceptives is small, patients should nevertheless be informed that the risk exists.

Acne Vulgaris↗