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A C van Grootheest

Publications and source records attributed to A C van Grootheest.

10 recordsLinked to original sources
PubMed2001

[Uneasiness about the safety of bupropion as an aid to smoking cessation unjustified ].

A report in a national newspaper on Thursday 26 April 2001, linked the anti-smoking drug bupropion to 41 deaths. From the reports of suspected adverse reactions received by the Netherlands Pharmacovigilance Foundation, it appears that more than half the cases concerned patients at risk of developing smoking-related diseases. In 15 cases, the simultaneous use of bupropion and another antidepressant (10 patients), theophylline (1 patient) or insulin (4 patients) was reported, even though these combinations may lead to an increase in the risk of seizures. Furthermore, 2 patients were reported to have been taking anti-epileptics, despite the fact that use of bupropion is contra-indicated in patients with a seizure disorder. The results seem to illustrate that the guidelines described in the product information are not being adhered to in all cases. Provided that bupropion is used according to the guidelines in the product information, this new aid in smoking cessation is considered an effective and safe drug. It is highly unlikely that bupropion has contributed to any deaths. If prescribed appropriately and in combination with counselling (e.g. minimal intervention strategy), bupropion is as yet the most effective aid in helping people stop smoking.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

[Side effects of sildenafil: findings from two years practical experience].

Sildenafil has been registered for the treatment of erectile dysfunction since 1998. World wide a large number of patients were reported, dying of acute heart disease after using sildenafil. Therefore the patient instruction text was adapted. Simultaneous use of sildenafil and nitrates is contraindicated because of serious decrease of the blood pressure. The use of sildenafil can lead to physical stress in patients with a history of heart disease and a treadmill test assessment is advisable. In two years 38 adverse reactions were seen in 25 Dutch patients. The Dutch reports (three cardiovascular deaths since the introduction) also show the dilemmas in the assessment of the safety of sildenafil: is it the underlying disease or is it the drug that causes death? Further research into the adverse reactions has to be done, therefore reporting suspected side effects of sildenafil is important.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

[Delirium due to increase in clozapine level during an inflammatory reaction].

Between January 1999 and May 2000, the Netherlands Pharmacovigilance Foundation LAREB received five reports of patients with clozapine intoxication attributed to inflammation. The reports all concerned men with schizophrenia, aged 63, 54, 41, 45 en 42 years. The occurrence of increased clozapine levels during inflammation, and normalisation after recovery, strongly suggest a causal relationship. No other possible explanations were found. A three to five-fold increase occurred in most instances, but one patient experienced a ten-fold increase compared with the basal levels of clozapine. Three of the patients developed a delirium as an intoxication symptom, probably due to anticholinergic effects on the central nervous system. In case of an inflammatory reaction in patients on clozapine treatment, the physician should be aware of the possibility of clozapine intoxication and delirium. Measuring clozapine levels during infection and dosing based on these levels can minimise the adverse effects of clozapine intoxication.

Adult↗
PubMed2001

[Risk of convulsions due to the use of bupropion as an aid for smoking cessation].

Bupropion is a new aid in smoking cessation. Since marketing of this product in the Netherlands (from December 1999 on), 7 cases of (possible) convulsions have been reported. In 3 cases there was a contraindication in the form of a history of epilepsy. The four other cases concerned tonic-clonic epileptic seizures in patients with no history of epilepsy and no combination with other medication. In view of the seriousness of this, already known, side effect of bupropion, physicians ought to be sensitive to situations with increased risk of this side effect. In addition it is advised to explain to the patient the proper use of bupropion, which is not comparable to nicotine chewing gum and should be swallowed whole due to the slow release properties of the tablet.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

Attitudinal survey of voluntary reporting of adverse drug reactions.

AIMS: Voluntary adverse drug reaction (ADR) reporting schemes have operated since the early sixties in many Western countries. It is generally recognized, however, that only a small proportion of ADRs is actually reported. The current survey was conducted to assess attitudes towards reporting of ADRs, and to study which types of ADRs are reported. METHODS: A questionnaire seeking reasons for nonreporting was sent to a random sample of 10% of medical practitioners in The Netherlands in October 1997. After 6 weeks, a reminder was sent to those who had not responded. RESULTS: One thousand four hundred and forty-two (73%) questionnaires were returned, of which 94% were complete. The percentage of GPs (51%) which had ever reported an ADR to the national reporting centre was significantly higher than the percentage of specialists (35%), who reported more often to the pharmaceutical industry (34% vs 48%). 86% of GPs, 72% of surgical specialists and 81% of medical specialists had ever diagnosed an ADR, which they had not reported. Uncertainty as to whether the reaction was caused by a drug (72%), the ADR being trivial (75%) or too well known (93%) were the most important reasons for not reporting. 18% were not aware of the need to report ADRs, 22% did not know how to report ADRs, 38% did not have enough time, 36% thought that reporting was too bureaucratic and only 26% of Dutch physicians knew which ADRs to report. A serious ADR, an unlabelled ADR, an ADR to a new drug, history of reporting of one or more ADRs, and specialty were all independently associated with reporting of 16 hypothetical ADRs. Surgical and medical specialists tended to report less often than GPs. CONCLUSIONS: There is a considerable degree of underreporting, which might partly be explained by lack of knowledge and misconceptions about spontaneous reporting of adverse drug reactions.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

Contribution of pharmacists to the reporting of adverse drug reactions.

PURPOSE: The aim of the study is to get a better view about the possible contribution of pharmacists' reports to the quantity and the quality of reports and in this way to the quality of a voluntary reporting system of adverse drug reactions. METHODS: A total of 15,293 reports, sent to the Netherlands Pharmacovigilance Foundation Lareb between 1995 and 2000 were analysed for the characteristics of pharmacists' reports and the differences with reports from physicians i.e. dispersion of adverse drug reactions in relation to the different System and Organ Classes, the seriousness of the reports according to the CIOMS criteria and the documentation grade of the reports. A total of 200 reports were selected at random and their quality assessed. RESULTS: Pharmacists are responsible for 40% of the reports sent in to Lareb during this period. Their reports more frequently concern adverse effects in relation to skin and the eyes. Adverse drug reactions reported by pharmacists tend to be less severe than those reported by physicians and pharmacists' reports tend to be of a lower documentation grade than those of physicians. Also, the quality of the clinical information is higher in physicians' reports. CONCLUSIONS: The contribution of pharmacists to the voluntary reporting system in the Netherlands is of great importance, both for the number and quality of the reports.

Adverse Drug Reaction Reporting Systems↗