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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 73 records · Page 4Linked to original sources
PubMed1997

[Liver damage associated with the combination drug amoxicillin-clavulanic acid (Augmentin)].

OBJECTIVE: To describe the case histories of patients with liver damage associated with the antibacterial combination amoxicillin-clavulanic acid. DESIGN: Descriptive. SETTING: University Institute for General Practice, Rotterdam, the Netherlands. METHOD: All reports (n = 40) of hepatic injury, attributed to amoxicillin-clavulanic acid (causal relationship 'possible', 'probable' or 'certain') and received by the Drug Safety Unit of the Inspectorate for Health Care since the registration of the combination (1982) until August 1996 were described and evaluated. RESULTS: The reports concerned 28 men and 12 women with an average age of 61 years who had used the drug mostly for a respiratory tract infection. The latency period between first in-take and onset of the reaction was 3 weeks on average. The mean duration of hepatic injury was approximately 6 weeks. The liver injury resolved fully. Five patients had had the reaction on more than one occasion. The main symptoms were jaundice, nausea, pruritus and abdominal pain. The pattern of hepatic injury was mostly cholestatic or mixed hepatocellular-cholestatic. CONCLUSION: Since liver damage to amoxicillin-clavulanic acid appears to be infrequent, this adverse effect is probably not caused by amoxicillin alone. The risk of liver damage to amoxicillin-clavulanic acid is highest in elderly patients treated with the combination on several occasions. Doctors should restrict the use of this combination to the treatment of infections with amoxicillin-resistant bacteria.

Amoxicillin↗
PubMed1997

[Inflammation of the salivary glands attributed to the use of nitrofurantoin].

In six patients, women of 49, 59, 71, 82, 76 and 64 years old, acute inflammation of parotid and submandibular salivary glands was diagnosed. All were using nitrofurantoin as treatment for urinary tract infection. The symptoms disappeared after the treatment was discontinued. There were no signs of hypersensitivity to nitrofurantoin. Three of the patients had similar complaints during previous treatment with nitrofurantoin.

Aged↗
PubMed1997

Characteristics and determinants of sumatriptan-associated chest pain.

BACKGROUND: Serious cardiac adverse reactions, including myocardial infarction, have been attributed to the antimigraine drug sumatriptan succinate. Chest pain is considered to be a relatively common adverse reaction to sumatriptan. DESIGN: Postmarketing study. PATIENTS AND METHODS: The study was a part of a national cohort study on adverse reactions to sumatriptan, which was performed with the assistance of drug-dispensing general practitioners in the Netherlands. After data were collected on observed adverse reactions, the patients received a second questionnaire, with specific questions regarding the adverse event, and questions regarding medical history, other health complaints, and smoking habits. Furthermore, they had a physical examination and a blood cholesterol measurement. RESULTS: A total of 137 patients with chest pain associated with intake of sumatriptan were identified and compared with 229 consumers of sumatriptan without this adverse reaction. After multivariate analysis, young age, hypertension, general complaints of abdominal pain, and a family history of myocardial infarction were associated with an increased risk of chest pain attributed to sumatriptan. Hypertension in particular was a risk factor for sumatriptan-induced chest pain in men (relative risk, 8.0; 95% confidence interval, 1.8-40) compared with hypertension as a risk factor in women (relative risk, 1.63; 95% confidence interval, 0.9-3.1). CONCLUSIONS: Young age, hypertension, general complaints of abdominal pain, and a family history of myocardial infarction are associated with an increased risk of chest pain attributed to sumatriptan. Sex is an effective modifier of risk factors of sumatriptan-induced chest pain. In particular, hypertension is a strong risk factor in men.

Adult↗
PubMed1997

Neuro-psychiatric effects of antimalarials.

OBJECTIVE: To study the neuro-psychiatric adverse effects of antimalarial drugs. SETTING: Persons who visited a Travel Clinic in Rotterdam over a period of 3 months. DESIGN: Prospective cohort study on 394 persons taking mefloquine, 493 persons taking proguanil and 340 persons not taking antimalarial drugs who visited Africa, South America, Asia, or the Middle East. METHODS: All persons received a structured questionnaire within 14 days of their return to the Netherlands. The questionnaire consisted of questions regarding use of alcohol, smoking, general health, medical history, tropical diseases during the trip, and other medicines, and contained an extensive list of general complaints regarding all body systems at four levels of severity. A modified and validated version of the Profile of Mood States was included. RESULTS: In the study period, 2541 persons visited the Travel Clinic, of whom 1791 (70%) were both eligible and willing to co-operate. Of these 1791, data were obtained from 1501 (84%). Insomnia was most frequently encountered in users of mefloquine and mouth ulcers in proguanil users. After adjustment for gender, age, destination, and alcohol use, the relative risk for insomnia to mefloquine versus non-users of antimalarials was 1.6, and the excess risk was 6 per 100 users over an average period of 2 months. There were no significant differences between groups in depression, anxiety, agitation, and confusion. Stratification by gender demonstrated that insomnia was more common in women on mefloquine, but not in men. Also, women more frequently mentioned palpitations as an adverse event. After adjustment for age, destination, and alcohol use in women, the relative risks for insomnia and palpitations to mefloquine versus non-use of antimalarials were 2.4, and 22.5, respectively. When travellers were specifically asked for the adverse reactions they had experienced, anxiety, vertigo, agitation, and nightmares were significantly more frequently mentioned by mefloquine users. CONCLUSION: Insomnia was more commonly encountered during use of mefloquine than proguanil or during non-use of antimalarials.

Adult↗
PubMed1997

Drug-induced chest pain and myocardial infarction. Reports to a national centre and review of the literature.

OBJECTIVES: To analyse reports of drug-induced myocardial infarction and chest pain sent to a national reporting centre. To review which drugs were suspected of exhibiting these adverse events and what mechanisms were involved. METHODS: During the 20-year period 1975 through 1994, a total of 19,141 reports on adverse reactions to drugs were received by the Netherlands Centre for Monitoring of Adverse Reactions to Drugs. Of these 19,141 reports, 220 (1.1%) were concerned with drug-induced chest pain or myocardial infarction. After excluding reports in which the causal relationship was unlikely, poorly documented reports and reports on cases of overdosage, 183 reports (84%) were analysed. RESULTS: There were 130 reports (71%) of drug-induced chest pain and 53 reports (29%) of drug-induced myocardial infarction. A total of 104 reports concerned females (57%). The most frequently reported suspected drugs were the antimigraine drug sumatriptan (33 reports, 4 concerning myocardial infarction), the calcium antagonist nifedipin (9 reports, 2 of myocardial infarction) and nicotine [9 reports (8 patches, 1 chewing gum), 5 concerning myocardial infarction]. There were 18 reports of a fatal outcome. CONCLUSIONS: Several drugs can produce chest pain or myocardial ischaemia. It is important to recognise drugs as a potential cause, especially in patients with normal coronary arteries.

Adverse Drug Reaction Reporting Systems↗
PubMed1997

Fever attributed to the use of hydroxyurea.

We report on three patients who developed fever after starting treatment with the anti-neoplastic agent, hydroxyurea. Fever occurred within 5 days to 3 weeks after starting treatment. In all cases the causal relationship between fever and use of hydroxyurea was demonstrated by spontaneous recovery after drug withdrawal and was confirmed by recurrence of fever after rechallenge. Other causes were excluded. Fever was accompanied by rash, gastro-intestinal and pulmonary symptoms, and arthralgia. Physicians should be aware of the fact that unexplained fever may be caused by hydroxyurea.

Aged↗
PubMed1997

A nested case-control study on mortality in users of ibopamine.

BACKGROUND: A recent interim analysis of the PRIME II placebo-controlled study showed a significantly higher mortality in the group treated with ibopamine than in the control group. The objective was to study mortality in patients on ibopamine, and to assess risk factors for death. METHODS: All 2147 drug-dispensing outlets (DDO) in the Netherlands were asked to provide a printout of the complete medication history of users of ibopamine. A reaction was received from 92% of the DDO. From the 14,024 identified former or current users of ibopamine, a sample of 3148 patients (22%) was enrolled in the follow-up study. All general practitioners (GP) of these patients received an enquiry pertaining to the vital status of their patient, cause of death, primary cause and NYHA classification of heart failure, echo- and electrocardiographic data, serum creatinine, admissions and the effects of ibopamine. Cases were defined as patients who died during the follow-up period which ended on the day of return of the questionnaire or the day of decease (index date). Two random controls were obtained for each case from the non-deceased patients at the index date. The design was a follow-up study with risk factor assessment in a nested case-control design. RESULTS: Questionnaires were returned regarding almost 70% of the sample. Mortality in this group was 25%. A case-control analysis was performed with the first 104 cases and 208 random controls. Patients with NYHA class IV had a 3-times increased risk of dying. In patients with a serum-creatinine level in the highest quartile the risk of dying was increased threefold. Higher doses of ibopamine seemed to have a protective effect. Significantly more cases than controls used amiodarone. Also, opioids were used more often, which may be related to their use in terminal cardiac failure. CONCLUSION: NYHA classification and serum-creatinine levels were independent risk factors for death in patients with heart failure on ibopamine. Although there were increased risk estimates for current use of ibopamine and amiodarone, these did not reach statistical significance. This may be related, however, to the fact that this analysis was restricted to the first 20% of cases.

Aged↗
PubMed1997

The risk of acute liver injury associated with cimetidine and other acid-suppressing anti-ulcer drugs.

AIMS: The objective of this study was to estimate the risk of acute liver injury associated with individual acid-suppressing drugs and assess the role of dose and duration of treatment. METHODS: We used a nested case-control study design within a cohort of over 100,000 users of cimetidine, famotidine, omeprazole and ranitidine. The primary source of information was the General Practitioners Research Database. We identified 108,981 persons aged 20-74 years who received at least one prescription for cimetidine, famotidine, omeprazole, or ranitidine during 1990-93, and we ascertained the first occurrence of clinically acute liver injury referred to a specialist or admitted to a hospital. RESULTS: After review of medical records, 33 patients were considered eligible cases of idiopathic acute liver injury with no fatal cases. The type of liver injury was hepatocellular in almost half of the cases, and 80% of all cases presented with jaundice. Twelve cases occurred among current users of cimetidine, five among ranitidine users and one in an omeprazole user. The absolute risk of acute liver injury associated with cimetidine was estimated to be slightly greater than one per 5000 users of cimetidine. The adjusted relative risk (RRs) and 95% CI of developing acute liver injury associated with current use of cimetidine compared to non-use was 5.5 (1.9-15.9), with omeprazole 2.1 (0.2-19.2) and with ranitidine 1.7 (0.5-5.8). In the absence of concomitant use of other hepatotoxic drugs, the RR with cimetidine was 14.4 (2.9-73.7). Among users of cimetidine, the risk was especially high in the first 2 months of starting therapy (RR: 11.3, 3.7-35.1) and at daily doses of 800 mg or greater (RR: 8.8, 3.0-26.0). CONCLUSIONS: Cimetidine was the individual anti-ulcer drug with the highest risk of developing symptomatic acute liver disease. Further data are required to confirm this finding. Our study indicates that there is a dose relationship and a short latent period between cimetidine treatment and acute liver injury.

Adult↗
PubMed1997

Adverse cardiovascular effects of NSAIDs in patients with congestive heart failure.

Congestive heart failure (CHF) is a complex clinical syndrome, especially in the elderly, which results from cardiac dysfunction. Epidemiological studies have shown a gradual increase in age-adjusted hospitalisation rates for CHF and overall population prevalence of CHF during the last 2 decades in Western countries. The healthcare costs associated with CHF are considerable and are likely to increase in the near future. Hence, identification of risk factors which could induce or exacerbate CHF is of major importance. NSAIDs are frequently prescribed in elderly patients for several rheumatological and nonrheumatological indications. Numerous adverse reactions, mainly related to the gastrointestinal tract and kidney function, have been described for NSAIDs. In addition, some case reports have suggested a causal relation between the use of NSAIDs and the onset of CHF. The pathophysiology of CHF and the pharmacological properties of NSAIDs support this hypothesis. In particular, the inhibition of prostaglandin synthesis may adversely affect cardiovascular homeostasis in patients with a propensity to develop CHF. Notwithstanding the adverse effects, however, the prescription of NSAIDs in elderly patients is often desirable and justifiable. Therefore, further pharmaco-epidemiological research is needed to quantify the risk for CHF attributable to the use of NSAIDs and to identify patients who are particularly susceptible to the adverse cardiovascular effects of these agents. In these patients, it may be advisable to avoid the use of NSAIDs.

Aging↗
PubMed1996

[Privacy and drug surveillance: a study of the viewpoints of medication users].

OBJECTIVE: To study the views of patients regarding privacy in relation to the procedures of postmarketing surveillance studies. DESIGN: A population-based cross-sectional study (survey). SETTING: Dutch community pharmacies. METHODS: From a source population of 1030 pharmacists 30 (2.9%) were selected at random; 28 (93.3%) of them co-operated with the investigation. Pharmacists were visited for one day each in their pharmacies during which visit their patients were asked to fill in a questionnaire. On the day of the visit, a random number of patients were asked whether the prescriptions were for themselves. 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 of privacy in relation to reporting of adverse drug reactions (ADR) and postmarketing surveillance studies. RESULTS: Of the 669 respondents 628 (94%) had no objection against the reporting of ADR to the Inspectorate for Health Care by their medical practitioner or pharmacist. 505 (77%) respondents did not object to the use of their medical data, even if these 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 had no objections to 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.

Adult↗
PubMed1996

[Reports of suspected side effects of selective serotonin reuptake inhibitors in Belgium and The Netherlands].

OBJECTIVE: To study the adverse drug reaction (ADR) profile of selective serotonin re-uptake inhibitors (SSRI) in Belgium and the Netherlands. DESIGN: Descriptive study. SETTING: The Belgian Pharmacovigilance Centre and the Dutch Drug Safety Unit. METHOD: All adverse reactions of fluoxetine, fluvoxamine, paroxetine and sertraline, reported between the moment of registration of these drugs and January 1st 1995, were assessed for causality. Possible, probable and certain adverse reactions were counted per drug and per country. RESULTS: At the national monitoring centres of Belgium and of the Netherlands adverse reactions were reported 78 and 537 times, respectively. Approximately 30% of the adverse reactions were well-established. Approximately 60% of the reactions were poorly documented or not serious. Less than 1% of the adverse reactions reported in Belgium and approximately 13% of the reactions reported in the Netherlands, were less established and/or serious. These reactions were: movement disorders and extrapyramidal reactions, convulsions, galactorrhoea, hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion, and purpura. CONCLUSION: The ADR profile was compatible with the ADR profile in the medical literature, but not all ADR were similarly represented in the product information of the different SSRI. More adverse reactions were reported in the Netherlands than in Belgium.

1-Naphthylamine↗
PubMed1996

Risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid.

BACKGROUND: Amoxicillin-clavulanic acid combination-associated hepatitis and jaundice was first identified in 1988. Numerous case reports and case series have been published since then, but there is no precise estimate of this risk. METHODS: A retrospective cohort study in the United Kingdom to estimate the risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid and compare it with the one of amoxicillin alone. Data were derived from a cohort of 93,433 users of the combination drug amoxicillin-clavulanic acid and 360,333 users of amoxicillin alone who were aged between 10 and 79 years and who were followed up from 1991 through 1992. After reviewing the information on subjects with suspected liver injury that was recorded on computer files, the clinical records of 177 patients from the attending general practitioners were requested. RESULTS: They were 35 cases of idiopathic acute liver injury. None was fatal. There were 14 cases of acute liver injury among users of amoxicillin alone. The type of liver injury was hepatocellular in half the cases. There were 21 cases of acute liver injury among users of amoxicillin and clavulanic acid together. The type of liver injury was cholestatic in three quarters of the cases. The incidence rates and 95% confidence intervals (CIs) of developing acute liver injury associated with the combination of amoxicillin and clavulanic acid and amoxicillin alone were 1.7 (1.1-2.7) and 0.3 (.02-0.5) per 10 000 prescriptions, respectively. The rate ratios and 95% CIs of acute liver injury for amoxicillin and clavulanic acid together compared with amoxicillin alone were 6.3 (3.2-12.7) for all patients and 8.4 (3.6-20.8) for patients presenting with jaundice. Among users of amoxicillin and clavulanic acid together, the risk of developing acute liver injury was more than 3 times greater after a course of 2 or more consecutive prescriptions than after a single course of therapy. The risk also increased with age among users of amoxicillin and clavulanic acid together. The combination of advancing age and repeated prescriptions resulted in a risk of developing acute liver injury greater than 1 per 1000 users of amoxicillin and clavulanic acid together.

Acute Disease↗
PubMed1996

[Clinically manifest liver lesions during use of simvastatin].

Symptomatic hepatic damage was diagnosed in six patients, three males and three females, during treatment with simvastatin. All patients recovered after discontinuation of the drug. One patient used the drug again, which led to another increase of serum liver enzyme activity. The period between the start of the treatment with simvastatin and the first symptoms of hepatic damage varied between 1 month and 3 years. If serum liver enzyme activities increase in patients using simvastatin, a causative relation should be considered.

Aged↗