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Biomedical subjects

E P van Puijenbroek

Publications and source records attributed to E P van Puijenbroek.

At least 19 recordsLinked to original sources
PubMed2007

Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Isotretinoin-induced inflammatory bowel disease.

Three case reports on inflammatory bowel disease associated with use of isotretinoin are described. All three patients were male adolescents, in good health when starting isotretinoin (for acne treatment for about six months). Several weeks after discontinuation of isotretinoin the patients developed severe symptoms requiring hospitalisation. The diagnosis of ulcerative colitis was made in two of these patients, while in the third patient Crohn's disease was diagnosed. Although inflammatory bowel disease is described as an adverse drug reaction in the product information of isotretinoin, few cases have been described so far. The link with prior isotretinoin use may not be recognised by the patient or the physician, since the diagnosis of inflammatory bowel disease is often preceded by several years of vague symptoms. On the other hand, spontaneous onset of inflammatory bowel disease (not related to isotretinoin) cannot be excluded. We appeal to the readers for a reaction to this, to shed more light on the likeliness of this alleged association.

Adolescent↗
PubMed2006

HMG-CoA-reductase inhibitors and neuropathy: reports to the Netherlands Pharmacovigilance Centre.

The number of patients taking HMG-CoA-reductase inhibitors for hypercholesterolaemia is growing rapidly. Treatment with HMG-CoA-reductase inhibitors significantly reduces the risk of cardiovascular morbidity and mortality, but may rarely cause serious adverse drug reactions (ADRs). The most serious ADRs of HMG-CoA-reductase inhibitors are musculoskeletal symptoms including myopathy and myositis, (life-threatening) rhabdomyolysis and liver failure. Furthermore, peripheral neuropathy might also occur, especially after long-term use of HMG-CoA-reductase inhibitors. Because of the severity and the relative rarity of HMG-CoA-reductase-induced neuropathy, the Netherlands Pharmacovigilance Centre Lareb has analysed its database of reported ADRs for reports concerning neuropathy associated with the use of HMG-CoA-reductase inhibitors. Until June 2005, Lareb received 17 reports of neuropathy, peripheral neuropathy and polyneuropathy and in addition two reports of aggravation of existing polyneuropathy associated with the use of HMG-CoA-reductase inhibitors. The associations neuropathy, peripheral neuropathy and polyneuropathy and the use of hMg-CoA-reductase inhibitors are statistically significantly more often reported to Lareb. The average time to onset supports conclusions of previous studies and case reports that especially long-term exposure increases the risk for peripheral neuropathy. Considering the increasing number of patients taking HMG-CoA-reductase inhibitors, health care professionals should be aware of the possible role of these drugs in neuropathy.

Adult↗
PubMed2005

[Side effects of tramadol: 12 years of experience in the Netherlands].

Tramadol is a synthetic opioid that has been available in the Netherlands since 1992 and is usually used as a centrally-acting analgesic when paracetamol or an NSAID provides insufficient relief. In the period 1 January 1992--30 November 2003, the Netherlands Pharmacovigilance Centre Lareb received 299 reports concerning 522 adverse drug reactions associated with the use of tramadol. Some of the frequently reported side effects with a high reporting odds ratio were nausea, constipation and withdrawal symptoms. These side effects are very similar to those of the other opioids due to the affinity of tramadol for the micro-opioid receptor. Because tramadol is often not recognised as an opioid, it is important that such opiate effects be recognised as an adverse drug reaction on time.

Analgesics, Opioid↗
PubMed2005

[Direct reporting of side effects by the patient: favourable experience in the first year].

OBJECTIVE: To determine the results of establishing a station at which patients can report the side effects of drugs. DESIGN: Descriptive. METHOD: Since 1 April 2003, patients may submit reports of possible adverse drug reactions directly to the Netherlands Pharmacovigilance Centre Lareb. The reports submitted during the period from 1 April 2003 to 31 March 2004 were analysed and compared with the reports submitted by doctors and pharmacists. RESULTS: In the first year, 276 reports were submitted by patients and 3131 by doctors and pharmacists. The reports from patients usually contained sufficient medical information and more frequently referred to serious adverse reactions than reports by health professionals. The reports from patients relatively often concerned psychotherapeutic agents, notably antidepressants. CONCLUSION: Based on the positive results during the first year, the Netherlands Pharmacovigilance Centre Lareb has decided to continue the reporting station for patients. Reports submitted by patients are currently part of the core responsibility of Lareb: the detection of signals of new adverse drug reactions.

Databases, Factual↗
PubMed2004

[Notifications to the Netherlands Pharmacovigilance Foundation Lareb of the expulsion of a vaginal contraceptive ring (NuvaRing) and of pregnancy during the use of it].

Netherlands Pharmacovigilance Foundation Lareb expulsion of the vaginal contraceptive ring NuvaRing was reported 8 times between February 2003 and April 2004. Moreover, in two of these reports pregnancy was reported. In that same period, Lareb received 10 more reports of pregnancy during the use of the ring, in which expulsion was not mentioned explicitly. Additional information on these cases was collected by questionnaire. Expulsion of the ring is described in the product information. The ring should then be placed back within 3 h. However, the Lareb reports show that expulsion of the ring is not always noticed by the user. In those cases the contraceptive efficacy of this method is questionable. The physician should be alert to pre-existing risk factors that increase the chance of expulsion of the ring, and should provide extra detailed advice about the right way of placing the ring, the risk of expulsion and the importance of replacing it in time.

Consumer Product Safety↗
PubMed2004

[Hyponatraemia during the use of selective serotonin re-uptake inhibitors (SSRIs): reports from 1992-2002].

OBJECTIVE: To describe the reports of serotonin re-uptake inhibitor (SSRI)-induced hyponatraemia that were sent to The Netherlands Pharmacovigilance Centre Lareb and the Inspectorate for Health Care. DESIGN: Descriptive study. METHOD: Reports of SSRI-induced hyponatraemia received by Lareb and the Inspectorate for Health Care during the period 1 January 1992 to 1 July 2002 were described on the basis of symptoms, co-medication and comorbidity. RESULTS; A total of 42 cases were reported, 38 (90%) of which concerned women and 21 (50%) of which concerned the concomitant use of SSRIs and diuretics. The mean age was 74 years (range: 30-91). The mean serum sodium concentration was 115 mmol/l (range: 97-132). The most important symptoms were reduced consciousness, confusion, falls, nausea and vomiting. 3 patients (7%) died in the period of the reported adverse drug reaction and 27 patients (64%) were hospitalised, of which 4 (10%) to the intensive care unit. CONCLUSION: These reports of suspected SSRI-induced hyponatraemia were attended with significant morbidity and substantial mortality. The considerable morbidity and substantial mortality in combination with the increasing use of SSRIs necessitates a clarification of the actual incidence and severity of SSRI-induced hyponatraemia.

Adult↗
PubMed2002

Non-sedating antihistamine drugs and cardiac arrhythmias -- biased risk estimates from spontaneous reporting systems?

AIMS: This study used spontaneous reports of adverse events to estimate the risk for developing cardiac arrhythmias due to the systemic use of non-sedating antihistamine drugs and compared the risk estimate before and after the regulatory action to recall the over-the-counter status of some of these drugs. METHODS: All suspected adverse drug reactions (ADRs) reported until July 1999 to the Netherlands Pharmacovigilance Foundation Lareb were used to calculate the ADR reporting odds ratio, defined as the ratio of exposure odds among reported arrhythmia cases, to the exposure odds of other ADRs (non-cases), adjusted for gender, age, reporter, year of reporting and comedication, stratified for the periods before and after the governmental decision in the Netherlands. RESULTS: Seven-hundred and thirty-seven cases of arrhythmia were reported, out of which there were 43 instances where the patients were using non-sedating antihistamines. In general non-sedating antihistamines are associated with cardiac arrhythmia to a higher extent in comparison with other drugs (ADR reporting odds ratio 2.05 [95% CI: 1.45, 2.89]). The association between arrhythmias and non-sedating antihistamine drugs calculated before 1998 was not significantly higher than 1 (OR 1.37 [95% CI: 0.85, 2.23]), whereas the risk estimate calculated after the governmental decision did significantly differ from 1 (OR 4.19 [95% CI: 2.49, 7.05]). CONCLUSIONS: Our data suggest that non-sedating antihistamines might have an increased risk for inducing arrhythmias. Our findings, however, strongly suggest that the increased risk identified can at least partly be explained by reporting bias as a result of publications about and mass media attention for antihistamine induced arrhythmias.

Adolescent↗
PubMed2002

Extrapyramidal syndromes associated with selective serotonin reuptake inhibitors: a case-control study using spontaneous reports.

The aim of this study was to assess whether use of selective serotonin reuptake inhibitors (SSRIs) is associated with extrapyramidal syndromes (EPS). We analysed the spontaneous reports of adverse drug reactions (ADRs) collected by The Netherlands Pharmacovigilance Foundation Lareb in the period 1985-99 (n = 24,263). The study population comprised all patients using an antidepressant drug at the time the ADR occurred. We calculated ADR-reporting odds ratios (ADR-OR) to estimate the association between SSRI-use and EPS, relative to other antidepressants. We identified 61 patients with EPS. SSRI-use was associated with spontaneous reporting of EPS compared to other antidepressants (adjusted ADR-OR 2.2; 95% confidence interval 1.2-3.9). This risk estimate appeared to be higher in patients concurrently using antipsychotic medication (6.9, 0.7-68.0), although the confidence interval was very wide. In conclusion, SSRI-use seems only to be moderately associated with EPS compared to other antidepressants. However, those concurrently using antipsychotic drugs or presenting with other risk factors may be more susceptible and should be closely monitored.

Aged↗
PubMed2001

[Acute delirium, probably precipitated by clarithromycin].

Clarithromycin is a relatively new antibiotic with many applications. Its frequent use explains why side-effects previously reported seldom now become clear. Two patients, a man aged 74 and a woman aged 56 years, developed delirium after treatment with clarithromycin as part of eradication treatment of Helicobacter pylori, presumably as a result of an ideosyncratic reaction to the clarithromycin. Preclinical and clinical investigations did not reveal side effects on the central nervous system. By now the appearance of a delirium presumably related to the use of clarithromycin has been described in several patients. Furthermore some patients had a positive rechallenge. Finally, 17 reports on psychiatric side effects, of which 7 were delirium, after the use of clarithromycin reached the Netherlands Pharmacovigilance Foundation (Lareb). This combination of facts makes a causal relationship probable.

Acute Disease↗
PubMed2001

Tendon disorders attributed to fluoroquinolones: a study on 42 spontaneous reports in the period 1988 to 1998.

OBJECTIVE: Fluoroquinolone antibiotics have been associated with tendinitis and tendon rupture. In this paper we report on the followup of 42 spontaneous reports of fluoroquinolone-associated tendon disorders. METHODS: This study is based on cases of fluoroquinolone-associated tendon disorders reported to the Netherlands Pharmacovigilance Foundation Lareb and the Drug Safety Unit of the Inspectorate for Health Care between January 1, 1988, and January 1, 1998. By means of a mailed questionnaire, we collected information on the site of injury, onset of symptoms, treatment, and course of the tendon disorder as well as information on possible risk factors and concomitant medication. RESULTS: Of 50 mailed questionnaires, 42 (84%) were returned. The data concerned 32 patients (76%) with tendinitis and 10 patients (24%) with a tendon rupture. Sixteen cases (38%) were attributed to ofloxacin, 13 (31%) to ciprofloxacin, 8 (19%) to norfloxacin, and 5 (12%) to pefloxacin. There was a male predominance, and the median age of the patients was 68 years. Most of the reports concerned the Achilles tendon, and 24 patients (57%) had bilateral tendinitis. The latency period between the start of treatment and the appearance of the first symptoms ranged from 1 to 510 days with a median of 6 days. Most patients recovered within 2 months after cessation of therapy, but 26% had not yet recovered at followup. CONCLUSION: These reports suggest that fluoroquinolone-associated tendon disorders are more common in patients over 60 years of age. Ofloxacin was implicated most frequently relative to the number of filled prescriptions in the Netherlands.

Adult↗
PubMed2001

Determinants of signal selection in a spontaneous reporting system for adverse drug reactions.

AIMS: Detection of new adverse drug reactions (ADR) after marketing is often based on a manual review of reports sent to a Spontaneous Reporting System (SRS). Among the many potential signals that are identified, only a limited number are important enough to require further attention. The goal of this study is to gain insight into factors contributing to the selection and dissemination of possible signals originating from the SRS maintained by the Netherlands Pharmacovigilance Foundation. METHODS: In a case control design, all signals (n = 42) disseminated to the Medicines Evaluation Board from the second quarter of 1997 until the third quarter of 2000, which could be expressed as a combination of a single ATC code and a single WHO preferred term, were included. For each case, four controls were matched in time. Logistic regression analysis was used to investigate the influence of various factors, such as the fact whether the ADR or drug is new, the strength of the association, the seriousness of the reaction and the documentation of the reports. RESULTS: Multivariate analysis showed that the presence of a 'serious report' (Odds Ratio 3.8, 95% CI 1.3, 11.0), a WHO 'critical term' (OR 4.7, 95% CI 1.8, 13), the ADR being unlabelled (OR 6.1, 95% CI 2.3, 16) and the presence of a disproportionate association (OR 3.5, 95% CI 1.4, 8) were all independently associated with signal selection. The number of reports and the time after marketing of the drug had no influence. CONCLUSIONS: This study showed that selection of signals is based on both qualitative and quantitative aspects. Knowledge of these factors may improve the efficiency of the underlying signal selection process.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Detecting drug-drug interactions using a database for spontaneous adverse drug reactions: an example with diuretics and non-steroidal anti-inflammatory drugs.

OBJECTIVE: Drug-drug interactions are relatively rarely reported to spontaneous reporting systems (SRSs) for adverse drug reactions. For this reason, the traditional approach for analysing SRS has major limitations for the detection of drug-drug interactions. We developed a method that may enable signalling of these possible interactions, which are often not explicitly reported, utilising reports of adverse drug reactions in data sets of SRS. As an example, the influence of concomitant use of diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) on symptoms indicating a decreased efficacy of diuretics was examined using reports received by the Netherlands Pharmacovigilance Foundation Lareb. METHODS: Reports received between 1 January 1990 and 1 January 1999 of patients older than 50 years were included in the study. Cases were defined as reports with symptoms indicating a decreased efficacy of diuretics, non-cases as all other reports. Exposure categories were the use of NSAIDs or diuretics versus the use of neither of these drugs. The influence of the combined use of both drugs was examined using logistic regression analysis. RESULTS: The odds ratio of the statistical interaction term of the combined use of both drugs was increased [adjusted odds ratio 2.0, 95% confidence interval (CI) 1.1-3.7], which may indicate an enhanced effect of concomitant drug use. CONCLUSION: The findings illustrate that spontaneous reporting systems have a potential for signal detection and the analysis of possible drug-drug interactions. The method described may enable a more active approach in the detection of drug-drug interactions after marketing.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

[Lengthening of the QT-interval in a newborn treated with cisapride].

In a 7-week-old female infant a prolonged QTc interval, up to 485 ms, was measured and attributed to the use of the prokinetic agent cisapride. The girl was born at 32 1/7 weeks of gestational age, started to use cisapride (0.8 mg/kg/day) at the age of 7 weeks because of gastro-oesophageal reflux. After cessation of cisapride therapy, the QTc interval returned to normal. A normal QTc interval had also been observed before the use of cisapride. Because of the risk of QTc prolongation and possibly cardiac arrhythmias during the use of cisapride by newborn infants, electrocardiography should be performed before and during cisapride therapy; they should also be checked for possible risk factors like electrolyte disturbances and congenital QTc prolongation. Prudence is called for in case of patients with pre-existing disorders which could result in QT prolongation like electrolyte disturbances, congenital QT prolongation, and the concomitant use of medication associated with QT prolongation.

Cisapride↗
PubMed1999

Bladder dysfunction during the use of tramadol.

The Netherlands Pharmacovigilance Foundation LAREB received five case reports concerning transient impairment of micturition or urinary retention, suspected to be induced by tramadol. In all patients--three women and two men--the symptoms occurred in temporal association with the use of tramadol and promptly recovered after stopping of the drug. Tramadol was taken orally in doses within the recommended therapeutic range (150 mg or less daily). Disturbance of micturition is not mentioned as a side-effect in the summary of product characteristics of Tramal 50 and 100. Tramadol is an opioid agonist, however, and morphine is known to increase the tonus of the bladder sphincter and to cause urinary retention.

Journal Article↗