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  • 1
    Electronic Resource
    Electronic Resource
    Drug-induced chest pain and myocardial infarction. Reports to a national centre and review of the literature (1997)
    Springer
    European journal of clinical pharmacology 53 (1997), S. 105-110 
    Details
    ISSN: 1432-1041
    Keywords: Key words Myocardial infarction ; Drug induced ; Angina pectoris
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050346
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  • 2
    Electronic Resource
    Electronic Resource
    Cough due to ace inhibitors: a case-control study using automated general practice data (1996)
    Springer
    European journal of clinical pharmacology 49 (1996), S. 439-444 
    Details
    ISSN: 1432-1041
    Keywords: Key words ACE inhibitors; cough ; epidemiological study ; general practice
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract. 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050047
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  • 3
    Electronic Resource
    Electronic Resource
    Neuro-psychiatric effects of antimalarials (1997)
    Springer
    European journal of clinical pharmacology 52 (1997), S. 1-6 
    Details
    ISSN: 1432-1041
    Keywords: Key words Cohort study ; Mefloquine ; Proguanil ; Psychic adverse effects ; Antimalarial drugs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050240
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  • 4
    Electronic Resource
    Electronic Resource
    Adverse reactions attributed to sumatriptan (1994)
    Springer
    European journal of clinical pharmacology 47 (1994), S. 305-309 
    Details
    ISSN: 1432-1041
    Keywords: Sumatriptan ; Migraine ; pharmacoepidemiology ; adverse reaction ; angina pectoris ; postmarketing surveillance ; general practitioner
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug in The Netherlands. With assistance of 86% of the drug dispensing general practitioners in The Netherlands, 1727 patients who had received sumatriptan were traced in July, 1992. Via their general practitioners, a questionnaire about use of sumatriptan, adverse reactions and other medication was sent to the patients in December 1992. During the study period, seven patients were lost to follow-up. Of the 1720 remaining patients, 1202 (70%) responded to the questionnaire, of whom 1187 had actually used sumatriptan. The most frequently reported suspected adverse reactions were paraesthesiae (139 patients, 95% CI 9.9%–13.5%) and dizziness (96 patients, 95% CI 6.5%–9.7%). Chest pain after use of sumatriptan was reported by 94 patients (7.9%, 95% CI 6.4%–9.4%), and according to the close temporal relationship with the intake of sumatriptan and a positive rechallenge, a causal relationship was probable in most of those patients. The frequency of chest pain attributed to sumatriptan was higher in females (9.0% vs 4.6%; relative risk 1.9, 95% CI 1.1–3.4). Age and hypertension were not associated with chest pain attributed to sumatriptan. Dyspnoea attributed to sumatriptan was reported by 26 patients (2.2%), and was associated with obstructive lung disease (relative risk 5.4 95% CI 1.7–16.9). Thus, in view of the high frequency of chest pain after use of sumatriptan and reports in the literature of cardiac disturbances, including myocardial infarction, cautious use of the drug is advised.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00191159
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  • 5
    Electronic Resource
    Electronic Resource
    Pattern of sumatriptan use and overuse in general practice (1996)
    Springer
    European journal of clinical pharmacology 50 (1996), S. 353-355 
    Details
    ISSN: 1432-1041
    Keywords: Key words Sumatriptan ; Postmarketing surveillance ; Migraine; overuse ; pharmacoepidemiology
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050122
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  • 6
    Electronic Resource
    Electronic Resource
    Communicating a drug alert (1994)
    Springer
    European journal of clinical pharmacology 47 (1994), S. 125-132 
    Details
    ISSN: 1432-1041
    Keywords: Postmarketing surveillance ; acitretin ; Adverse drug reaction ; etretinate ; communication ; mass media
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract In October 1990, a recall procedure was initiated for the teratogenic drug acitretin, and the recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years due to the possibility of its conversion to the lipophilic compound etretinate. The aim of the present study was to evaluate the communication procedures and their effects as a drug alert from the health authorities, the pharmaceutical company and professional associations of health professionals to the population at risk. A model was used to evaluate communication between three hierarchical levels. Data were obtained via semi-structured interviews and structured questionnaires. Communication procedures were evaluated according to channel characteristics and by analysis of their contents. The effect was measured as whether the drug dispensers identified acitretin users, contacted physicians, and whether physicians communicated in person with the population at risk. The penetration of direct mail from the health authorities and from the pharmaceutical company ranged from 97–98% and 65–94% at Level 2 (health professionals). The population at risk was informed via personal communication with health professionals, and/or the mass media. Of the women at risk, 19% were contacted by a dermatologist, 30% by their GP, and 39% by the pharmacist. 35% was never informed by any health professional. The Dutch health care system is adequately equipped for effective communication between health authorities, pharmaceutical industry and health professionals. Due to problems with identification in terms of past exposure, subsequent personal communication between health professionals and the population at risk was inadequate. Therefore, the role in personal communication of health professionals should be increased, as they can rapidly identify persons at risk as a result of previous exposure. In The Netherlands drug dispensers should have an important role.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194961
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  • 7
    Electronic Resource
    Electronic Resource
    A rapid method to estimate the incidence rate and prevalence of insulin-dependent diabetes mellitus in children 0–19 years of age (1995)
    Springer
    Pharmacy world & science 17 (1995), S. 17-19 
    Details
    ISSN: 1573-739X
    Keywords: Child ; Data collection ; Diabetes mellitus, insulin-dependent ; Epidemiologic methods ; Incidence ; Pharmacy records ; Prevalence
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Objective To trace new cases of insulin-dependent diabetes mellitus (IDDM) on an ongoing basis and to estimate the incidence rate and prevalence of IDDM in children 0–19 years of age. Research design and methods The estimation of the prevalence and incidence rate of IDDM was based on, respectively, the prevalence and the rate of new users of insulin. The data were obtained from pharmacy, patient-based, drug dispensing histories in a well-defined population encompassing 257, 113 individuals in the Netherlands. Results The IDDM incidence rate was estimated at 11.5 (CI95 6.6–17.8) per 100,000 person years in 1989–1990 in children 0–19 years of age. The prevalence was estimated at 11.0 (CI95 8.6–13.4) per 10,000 children 0–19 years of age. Discussion The incidence rate is comparable to that found in a large, national survey among all paediatricians and internists in the Netherlands. The method offers ongoing monitoring of the incidence and prevalence of IDDM in children, 0–19 years of age, against low costs. The method is suitable for rapid and cost-efficient recruitment of cohorts of incident IDDM patients, which fosters research to identify and quantify the attribution of different types of aetiologic and prognostic factors of IDDM.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01875553
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  • 8
    Electronic Resource
    Electronic Resource
    Acitretin (Neotigason®) (1992)
    Springer
    Pharmacy world & science 14 (1992), S. 33-37 
    Details
    ISSN: 1573-739X
    Keywords: Acitretin ; Etretinate ; Metabolism ; Pharmacokinetics ; Retinoids ; Teratogens
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01980479
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  • 9
    Electronic Resource
    Electronic Resource
    Bromocriptine and suppression of postpartum lactation (1995)
    Springer
    Pharmacy world & science 17 (1995), S. 133-137 
    Details
    ISSN: 1573-739X
    Keywords: Adverse effects ; Bromocriptine ; Cardiovascular diseases ; Cerebrovascular disorders ; Incidence ; Lactation ; Product surveillance, postmarketing
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The use of bromocriptine for the suppression of postpartum lactation drew widespread attention to a potentially increased risk for cardiovascular and cerebrovascular adverse effects. To estimate the incidence of these events a follow-up study was performed among 2,130 women of 15–44 years of age who were treated with a course of bromocriptine in 1990–1992. None of these women were admitted to the hospital for cardiovascular or cerebrovascular events. However, the incidence of pregnancy hypertension and the use of cardiovascular drugs increased considerably in the last 2 months before delivery. Therefore, cardiovascular or cerebrovascular events can probably be explained by pre-existing morbidity rather than by the use of bromocriptine. We estimated, using a ‘worst-case’ analysis, that fewer than 2 Dutch women each year would develop serious cardiovascular or cerebrovascular events.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01872390
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  • 10
    Electronic Resource
    Electronic Resource
    The role of pharmacists in the recruitment of a cohort for postmarketing surveillance (1995)
    Springer
    Pharmacy world & science 17 (1995), S. 126-132 
    Details
    ISSN: 1573-739X
    Keywords: Acitretin ; Data collection ; Dermatologists ; Drug utilization ; Epidemiological methods ; Pharmacists ; Product surveillance, postmarketing
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01872389
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