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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 91 records · Page 5Linked to original sources

[Granulomatous hepatitis attributed to the combination pyrimethamine-chloroquine].

After her holiday in South Africa, a 50-year-old woman was admitted because of fever and pain in the upper abdomen. The laboratory tests showed moderately increased serum liver enzyme activities. The liver biopsy showed a granulomatous hepatitis. Further investigations revealed no evidence for sarcoidosis, tuberculosis or infectious hepatitis, nor for other granulomatous diseases or infectious diseases relevant to South Africa. Upon discontinuation of the malaria prophylaxis with Daraclor (pyrimethamine and chloroquine (sulphate)) the symptoms disappeared and the liver function tests returned to normal. It was concluded that Daraclor was the probable cause of granulomatous hepatitis in this patient. This adverse effect was not published before.

Antimalarials↗

The use of confidential medical data and postmarketing surveillance: a survey of the opinion of patients.

OBJECTIVES: To study the perceptions of patients regarding privacy in relation to the performance of postmarketing surveillance studies. DESIGN: A population-based cross-sectional study (survey). SETTING: Out of a source population of 1030 pharmacists a random sample of 30 (2.9%) was taken. Twenty-eight (93.3%) of them co-operated with the investigation. Pharmacists were visited for 1 day each in their pharmacy during which visit their patients were questioned with a closed questionnaire. SUBJECTS: On the day of the visit a random sample of patients was taken and asked whether they had filled prescriptions for their own use. Out of a total of 1277 patients in the 28 pharmacies, 849 (66.5%) used the filled prescriptions themselves. Of these 849, 669 patients (78.8%) co-operated and completed a questionnaire pertaining to their perceptions and viewpoints of privacy in relation to the reporting of adverse drug reactions (ADR) and postmarketing surveillance studies. RESULTS: Of the respondents 94% had no objection to the reporting of ADR to the Inspectorate for Health Care by their medical practitioner or pharmacist. Among the respondents 77% did not object to the use of their medical data, even if these data were not anonymous, as long as the data were kept strictly confidential. Most patients were of the opinion that such data could be used without asking permission. Males would more readily give their permission than females. CONCLUSIONS: Most respondents did not have objections to the use of their medical data for postmarketing surveillance studies. The large majority of patients did not object to the reporting of ADR to the Inspectorate for Health Care.

Journal Article↗

Cough due to ACE inhibitors: a case-control study using automated general practice data.

OBJECTIVES: To determine the risk of coughing as an adverse reaction to ACE inhibitors under everyday circumstances in a large population, and to study whether this adverse effect was duration or dose dependent. DESIGN: A population-based case-control study. SETTING: Ten general practices of 14 Dutch general practitioners (GP), in which all consultations, morbidity and medical interventions, including drugs prescribed, were registered over the 18 month period from 1st September, 1992 to 1st March, 1994. SUBJECTS: 1458 patients with incident coughing and up to four controls per case were obtained (total 4182 controls), matched for GP. All cases and controls were 20 years or older and had no record of respiratory infection, influenza, tuberculosis, asthma, chronic bronchitis, emphysema, congestive heart failure, sinusitis, laryngitis, haemoptysis or respiratory neoplasms during the study period. RESULTS: Cases were 2.1-times more likely than controls to have been exposed to ACE inhibitors (95% CI 1.5-3.1), but after adjustment the odds ratio was 1.4 (95% CI 0.9-2.1). The crude odds ratio for captopril was 1.3 (95% CI 0.7-2.5), for enalapril 2.6 (95% CI 1.6-4.2) and for lisinopril 2.0 (95% CI 0.5-9.3). The adjusted odds ratio for captopril was 0.9 (95% CI 0.4-1.7), for enalapril 1.7 (95% CI 1.03-2.8) and for lisinopril 1.7 (95% CI 0.4-7.9). For patients who had been on ACE inhibitor treatment for no longer than 2 months the odds ratio was 4.8 (95% CI 1.7-13.3). The odds ratio declined to 2.0 (95% CI 1.1-3.8) for those who had taken an ACE inhibitor for 2-6 months, and to 1.6 (95% CI 0.9-2.7) for those on ACE-inhibitors for more than 6 months. CONCLUSION: The risk of coughing was increased twofold among ACE inhibitor users, but the odds ratios were no longer significant after controlling for several confounding factors. The risk of developing cough due to ACE-inhibitors declines with the duration of treatment, possibly due to depletion of susceptible persons.

Adult↗

Pattern of sumatriptan use and overuse in general practice.

OBJECTIVE: To investigate the frequency of use and misuse of sumatriptan, and to explore the characteristics of patients reporting overuse. SETTING: A postmarketing cohort study on adverse reactions to sumatriptan, performed with the assistance of drug-dispensing general practitioners in the Netherlands. METHODS: Questionnaires were sent to patients on sumatriptan of drug-dispensing general practitioners in the Netherlands. Use of sumatriptan was classified into five groups: < 1, 1-10, 11-20 and 21-30 times per month and a group of patients who reported daily use of sumatriptan more than 10 times per week. Patients in the latter group were regarded as "overusers". RESULTS: The request to the 1720 patients yielded a response rate of 1202 (70%). Of 952 (79%) of these patients, details of their sumatriptan intake were available. Most patients (718, 75%) took sumatriptan 1-10 times each month. However, 36 patients (4%, 95% CI 2.8-5.2%) took sumatriptan daily or more than 10 times each week. The group with the highest intake consisted mainly of males, and many patients who reported a poor efficacy of sumatriptan. Age was not related to use of sumatriptan. CONCLUSIONS: A small group of patients (4%) used sumatriptan too often. A high intake was associated with both male gender and a reported poor efficacy of sumatriptan, but not with age, reported adverse reactions, or headache attributed to sumatriptan. It is important to explain to patients that sumatriptan is only for the treatment of acute attacks, and not for prophylactic use. Drug consumption patterns have to be evaluated, in particular in patients who report low efficacy of sumatriptan.

Administration, Oral↗

Uveitis during treatment of disseminated Mycobacterium avium-intracellulare complex infection with the combination of rifabutin, clarithromycin and ethambutol.

Three patients with a cellular immunodeficiency were treated with rifabutin, clarithromycin and ethambutol for a disseminated infection with Mycobacterium avium-intracellulare complex (MAC). The patients developed uveitis, sometimes in combination with a transient rash, arthralgia, arthritis, jaundice and pseudojaundice. It seems likely that these reactions were caused by rifabutin, alone or together with other drugs such as clarithromycin. These adverse reactions probably depend on the dose, metabolism and excretion of the drug. Inhibition of cytochrome P450 seems to be an important mechanism.

AIDS-Related Opportunistic Infections↗

Current use of thiazide diuretics and prevention of femur fractures.

A case control study of a defined population from The Netherlands was performed to evaluate the risk of femur fractures associated with the use of thiazide diuretics. Included were 386 patients hospitalized for femur fractures between 1986 and 1990 who were residents and 45 years of age and older. Per case, one age-, sex-, pharmacy-, and general practitioner-matched control was chosen from the general population. Drug use was ascertained from computerized pharmacy records. The adjusted odds ratio of current use of thiazide diuretics was 0.5 (95% confidence interval, 0.3-0.9). The protective effect of thiazide diuretics was greatest for use of 1 year or longer at relatively high doses of thiazides (odds ratio, 0.3; 95% confidence interval, 0.1-0.9). We also found that patients who discontinued thiazide use longer than 2 months were not protected against femur fractures. These results support the hypothesis that use of thiazide diuretics protects against femur fractures.

Aged↗

A case of tizanidine-induced hepatic injury.

The case history is presented of a woman who developed serious liver injury while taking 36 mg tizanidine daily. Other causes of hepatic injury were excluded. Symptoms resolved after discontinuation of tizanidine, and the liver enzyme levels were nearly normal 6 weeks after discontinuation of the drug. Rechallenge with 4 mg tizanidine caused a relapse. The temporal relationship between the symptoms and liver enzyme elevations, the absence of other potential causes, and the reaction to rechallenge, strongly implicate tizanidine as the cause of hepatic injury. As we are not aware of similar case histories, this seems to be the first reported case of tizanidine-induced hepatic injury.

Chemical and Drug Induced Liver Injury↗

Taste loss to terbinafine: a case-control study of potential risk factors.

1. To identify risk factors associated with taste loss to terbinafine, we performed a case-control study of 87 reports of probably terbinafine-induced taste loss and 362 controls on terbinafine without taste loss, who had filled prescriptions from the same pharmacy and GP. Data on general health, diet, alcohol, smoking, drug use and medical history were collected by means of a self-administered questionnaire. 2. The mean latent period between first intake of terbinafine and taste loss was 35 days. Most patients recovered within 4 months after discontinuation. Cases were significantly older than controls. The odds ratio of taste loss in patients of 65 years and older was 4.4 in comparison with persons younger than 35 years of age (95% CI: 1.4-16.1). The risk in persons with a body mass index (BMI) below 21 kg m-2 was 4.4 times higher than in those with a BMI of more than 27 kg m-2 (95% CI: 1.6-14.2). The risk of taste loss in patients of 55 years and older with a BMI below 21 kg m-2 was 12.8 times higher than that in patients below 35 years of age (95% CI: 1.9-88.6). 3. A low BMI, a history of taste loss, and ageing are risk factors for developing taste loss to terbinafine. Prescription of this drug to elderly patients with low BMI and low daily intake of nutrients requires careful follow-up.

Adult↗

Drug-associated anaphylaxis: 20 years of reporting in The Netherlands (1974-1994) and review of the literature.

BACKGROUND: Since 1963, the Drug Safety Unit of the Dutch Inspectorate for Health Care (DSU) holds a voluntary reporting system. OBJECTIVE: To analyse all reports received in the years 1974 to 1994, registered as anaphylaxis or as a diagnosis that could contain cases of anaphylaxis. METHODS: All reports were classified as probable or possible anaphylaxis according to previously described criteria and the causal relationship between exposure and anaphylaxis was assessed. RESULTS: Nine hundred and ninety-two reports possibly concerning anaphylaxis were received between 1974 and 1994. Fifty-six were unclassifiable. The remaining 936 reports concerned 326 men and 610 women. Three hundred and forty-five reports were classified as anaphylaxis probable, 485 as anaphylaxis possible, and 106 as anaphylaxis unlikely by previously specified criteria. Drugs frequently associated with anaphylaxis (causal relationship certain or probable) were: glafenine (326 reports classified as anaphylaxis probable or possible), combination preparations with (propy)phenazone or propyphenazone/phenacetine (39), diclofenac (30), dextran (20), ibuprofen (14), floctafenine (12), allergen extracts (12), sulfamethoxazole with trimethoprim (12), and trimethoprim (11). There is probably substantial under-reporting as well as reporting bias in these data. Furthermore, many reports were classified as possible and not as probable anaphylaxis because the temporal relationship was unknown or not reported. CONCLUSION: Drugs that caused anaphylaxis most frequently were glafenine, NSAID and certain antibiotics. Data from a voluntary reporting system such as the DSU are valuable as an early warning system for drugs that may induce anaphylactic reactions.

Adult↗

[Discoloration of teeth by drugs].

Since 1979 the Dutch Centre for Monitoring of Adverse Reactions to Drugs received 37 reports of tooth discoloration, attributed to the use of drugs. It concerned sixteen males and 21 females with an average age of respectively twelve and 26 years. Most cases were attributed to the use of amoxicillin (n = 16) and doxycycline or minocycline (n = 7). Pseudo-discolorations are chiefly caused by antimicrobial agents, possibly by chromogenic precipitates in the pellicle or by overgrowth with chromogenic micro-organisms.

Adolescent↗

Vasculitis attributed to the nicotine patch (Nicotinell).

Nicotine-containing patches are used to facilitate tobacco withdrawal by mitigating abstinence symptoms and diminishing craving. We describe two patients who developed vasculitis in association with the use of a nicotine patch. The first concerns a patient who developed fever, arthritis, a generalized erythema and purpuric lesions, after 3 days use of nicotine patches. Laboratory results and a skin biopsy confirmed the diagnosis of a leucocytoclastic vasculitis. After stopping use of the patch, the patient recovered. On challenge, the symptoms reappeared. The second patient developed purpuric lesions during the use of nicotine patches, and recovered fully after these were stopped. In these patients, nicotine patches seem to be causally related to the development of vasculitis.

Adult↗

[Liver damage attributed to the use of disulfiram].

In three alcoholic patients, two men aged 30 and 42, and a woman aged 52, hepatitis was diagnosed after the use of disulfiram. In all cases, there was a close temporal relationship between the occurrence of symptoms and disulfiram intake. Other possible causes were excluded. The 30-year-old man died from liver damage. Biopsy showed massive hepatic necrosis without signs of alcoholic hepatitis. In the other patients, symptoms subsided quickly and liver function returned to normal after discontinuation of disulfiram, but there was no confirmation by biopsy. The possibility of drug-induced hepatitis should always be considered in an alcoholic patient treated with disulfiram.

Adult↗

[Reasons to report or not report side effects of drugs to the national monitoring system in the Netherlands].

OBJECTIVE: To assess the awareness of medical practitioners in the Netherlands regarding the national voluntary reporting scheme for adverse reactions to drugs, and the reasons for non-reporting. DESIGN: Questionnaire. SETTING: Netherlands Centre for Monitoring of Adverse Reactions to Drugs. METHOD: A questionnaire was sent to a random sample of 500 practitioners aged under 65 in the database of the Dutch Inspectorate for Health Care. RESULTS: Of the 500 questionnaires 265 (53%) were returned and completely filled in. Sixty-seven (25%) practitioners had reported a suspected adverse reaction on one or several occasions during their practising career; 229 (86%) would report a serious adverse reaction, 190 (72%) an unknown one, 185 (70%) an adverse reaction to a new product, and 83 (31%) a proven adverse reaction. Almost 20% said they had had difficulties reporting because they could not find the telephone number or reporting forms. Forty practitioners (15%) claimed that they were too busy to report adverse reactions. Almost all practitioners (94%) were aware of the fact that the reporting scheme serves the early detection of unknown adverse reactions.

Drug Monitoring↗

Benzodiazepines and the risk of falling leading to femur fractures. Dosage more important than elimination half-life.

BACKGROUND: In the past decade, the use of benzodiazepines has been identified as a major independent risk factor for accidental falls. OBJECTIVE: To study the role of dosing, timing, elimination half-life, and type of benzodiazepine in relation to the occurrence of accidental falls leading to hospitalization for femur fractures. METHODS: A 1:3 age-, sex-, and pharmacy-matched case-control study was performed using data from a Dutch record linkage system (PHARMO) (N = 300,000). Cases included 493 patients (55 years and older), newly admitted to the hospital for a femur fracture resulting from an accidental fall (between 1986 and 1992). Relative risk estimates were calculated using conditional logistic regression analyses to control for the potential confounding effects of concomitant drug use and presence of a wide range of underlying diseases. RESULTS: Falls were significantly associated with current use of benzodiazepines (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.1) and in particular with short half-life benzodiazepines (odds ratio, 1.5; 95% confidence interval, 1.1 to 2.0), sudden dose increases (odds ratio, 3.4; 95% confidence interval, 1.0 to 11.5), and concomitant use of several benzodiazepines (odds ratio, 2.5; 95% confidence interval, 1.3 to 4.9). A strong dose-response relationship (P < .0001) and dose-response relations among users of either short or long half-life benzodiazepines suggests that these increased risks are explained primarily by dose. CONCLUSIONS: Benzodiazepines are a major, independent risk factor for falls leading to femur fractures, and the increased risk is probably explained by prescribing too-high doses to the elderly.

Accidental Falls↗

The role of pharmacists in the recruitment of a cohort for postmarketing surveillance. A case study of acitretin in The Netherlands.

In October 1990, a recall procedure was issued regarding the drug acitretin. The recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years. For a postmarketing surveillance study, we recruited a cohort from the source population of women aged 15-45 years who were exposed to acitretin. Recruitment occurred through dermatologists, and pharmacists plus dispensing general practitioners. We describe the speed of and the response to the recruitment procedures, and the representativeness of the recruited cohort. We also studied whether the individuals who gave informed consent would have preferred to be recruited by either dermatologists or pharmacists, and whether the information obtained from pharmacists and dispensing general practitioners was valid. This study revealed that pharmacists and dispensing general practitioners (drug dispensers) recruited their subjects rapidly, with no or little selection; they attained a 42% response. Dermatologists recruited their subjects slowly and selectively; they attained a 24% response. The majority of women (60%) recruited by dermatologists would have given their informed consent if they would have been recruited by their pharmacists. Drug dispensers are essential contributors to the recruitment of a study population. We do advise that such recruitment for a postmarketing surveillance study occurs by means of a collaboration between pharmacists and physicians.

Acitretin↗