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Olav Spigset

Publications and source records attributed to Olav Spigset.

At least 19 recordsLinked to original sources
PubMed2007

Spontaneously reported fatal suspected adverse drug reactions: a 10-year survey from Sweden.

PURPOSE: One of the main methods for monitoring the safety of marketed drugs is spontaneously reporting of suspected adverse drug reactions (ADRs). The objective of this study was to describe the pattern of spontaneously reported fatal adverse drug reactions (FADRs) by analysing data from the national spontaneous reporting system in Sweden. METHODS: In Sweden it is compulsory to report all new or serious suspected ADRs to the Medical Products Agency. The information in these reports is stored in the national database SWEDIS (Swedish Drug Information System). All suspected FADRs reported to SWEDIS between 1 January 1995 and 31 December 2004 were reviewed and analysed. RESULTS: During the study period 990 reports of FADRs were found. The main distribution of suspected FADRs was: haemorrhages (n = 603; 60.9%), blood and bone marrow dysfunction (n = 71; 7.2%), sudden death (n = 38; 3.8%) and pulmonary embolism (n = 30; 3.0%). Antithrombotic agents were the drugs most frequently implicated in the FADRs (n = 605; 61.1%). Vitamin K antagonists were reported in 453 cases (45.8%) and acetylsalicylic acid in 82 cases (8.3%). Among the fatalities with blood and bone marrow dysfunction methotrexate was the most frequently reported drug. For sudden death and pulmonary embolism, antipsychotics and oestrogen containing drugs, respectively, were most commonly reported. CONCLUSIONS: Bleeding complications amounted more than half of all reports of FADRs and vitamin K antagonists were implicated in most of these reports. However, as spontaneous reporting systems are primarily set up for signalling purposes, the data must be interpreted with utmost care.

Adolescent↗
PubMed2006

[Written drug advertisements--are they reliable?].

BACKGROUND: Drug advertisements affect the practice and continuous education of physicians. We assessed whether drug advertisements in Norway were in accordance with national regulations in the field. METHODS: All drug advertisements received by three general practitioners during a period of three months were collected. One advertisement for each of the 50 pharmaceutical products most frequently advertised was reviewed, available references obtained, and the information evaluated in relation to Norwegian regulations. RESULTS: A total of 294 advertisements for 77 different products were reviewed. The 50 chosen advertisements contained 191 reference citations, of which 93% were retrieved. The originator of the advertisement in question provided 72% of the references we asked for. We identified 262 promotional claims for which the regulations require a reference citation. Of these, 135 (52%) did not comply with the regulations, including 15 (6%) that were false. CONCLUSION: Only half of the information presented in drug advertisements was correct and clinically relevant. Relatively few statements were false, but a considerable proportion of statements gave an excessively positive picture of the product; hence, in general, this kind of information has no value as a source of information.

Advertising↗
PubMed2006

[Generic drugs instead of brand drugs prescriptions--long overdue].

BACKGROUND: Generic substitution of drugs was introduced in Norway in 2001. This implies an obligation for pharmacies to substitute the prescribed drug with a generic equivalent. Instead of using the drug manufacturers' trade names, doctors can prescribe drugs by using the generic (non-proprietary) names. The present paper gives an overview over current practice in different countries and discusses advantages and drawbacks. MATERIALS AND METHODS: Literature on generic substitution and generic prescription was sought on PubMed. Regulatory authorities in Norway and other countries were approached for additional information. RESULTS: In the United Kingdom, generic prescription has been dominating for many years. In Sweden, a successful trial period with generic prescribing was recently reported. We have not identified any pharmacological arguments against generic prescription. INTERPRETATION: Available data suggest that generic prescribing of drugs should be encouraged. Generic prescribing is likely to improve patient safety by assuring that the prescribed drug is in fact what is dispensed.

Denmark↗
PubMed2006

Adverse drug reactions of antidepressants and antipsychotics: experience, knowledge and attitudes among Norwegian psychiatrists.

Efficient prevention of adverse drug reactions (ADRs) requires knowledge about their severity and pharmacological mechanisms and is dependent on reliable data on their frequencies and possible risk factors. The study was conducted to investigate the prescribers' experience and understanding of the ADRs of psychotropic drugs, and their attitude towards reporting these. In a questionnaire, physicians treating adult psychiatric patients were asked which ADRs that they regarded bothersome for some of the most widely used antidepressants and antipsychotics. Questions about the relationship between blockade of drug receptors and ADRs, and about the physicians' personal experience of and attitudes towards reporting of ADRs were also included. In total, 70 of 91 questionnaires (78%) were returned. The mean number of ADRs regarded bothersome ranged from 2.4 to 9.3 for the various drugs/drug classes. Qualified psychiatrists stated a significantly higher number of bothersome ADRs than did the residents. The percentage of physicians associating blockade of a receptor with a specific ADR varied from 76% (histamine receptor blockade and sedation) to 37% (alpha(1)-adrenergic blockade and tachycardia). Thirty-nine per cent of the physicians had never reported an ADR to the Norwegian Medicines Agency. The number of ADRs considered bothersome was relatively high. The pattern of these ADRs generally mirrored the typical ADR profiles of the drugs. The knowledge of the underlying mechanisms of ADRs was more or less incomplete. The reporting rate of ADRs to the national regulatory authorities was low.

Adult↗
PubMed2006

Risk factors for extrapyramidal symptoms during treatment with selective serotonin reuptake inhibitors, including cytochrome P-450 enzyme, and serotonin and dopamine transporter and receptor polymorphisms.

INTRODUCTION: Extrapyramidal symptoms (EPS) are rare adverse drug reactions to selective serotonin reuptake inhibitors (SSRIs). This study aimed to investigate the potential risk factors for EPS associated with SSRIs including polymorphisms of cytochrome P-450 isoenzymes, and serotonin and dopamine transporters and receptors. METHODS: All spontaneous adverse drug reaction reports received by the Swedish Medical Products Agency until December 1999 that were coded with EPS and judged to be at least possibly related to SSRI treatment were included in the study. Reporting physicians received a form for collection of relevant information including current and previous use of SSRIs and antipsychotics, alcohol or substance abuse, central nervous system damage, a history of epilepsy or EPS, and a family history of Parkinson disease. A blood sample was also requested for genotyping of selected cytochrome P-450, and serotonin and dopamine transporter and receptor mutations. RESULTS: A total of 64 cases of EPS were reported. Twenty-eight forms (46%) were returned, and 20 blood samples were obtained. Identified potential risk factors included age of 65 years or older and the presence of the A1 allele of the D2 dopamine receptor gene (DRD2) Taq1A polymorphism (relative risk, 2.4; 95% confidence interval, 1.2-4.5 vs literature controls). No relationship was apparent for sex, drug dose, or other genetic polymorphisms. At least 1 additional potential risk factor for EPS, such as a history of central nervous system damage, alcohol or substance abuse, epilepsy, Parkinson disease, previous or current exposure to antipsychotic drugs, concomitant treatment with other antidopaminergic or serotonergic agents, or a history of EPS, was found in 93% of the cases. CONCLUSION: The risk of EPS with SSRIs seems to increase with advanced age and with the presence of the A1 allele of DRD2 Taq1A polymorphism. Because of the small sample size of our study and the use of historical controls rather than patients who did not experience EPS during SSRIs treatment, the DRD2 finding is preliminary and needs to be replicated in other studies before firm conclusions can be drawn. At least 1 additional potential risk factor was found in almost all cases.

Adult↗
PubMed2005

Patterns of drug prescription in a geriatric evaluation and management unit as compared with the general medical wards: a randomised study.

OBJECTIVE: This study's objective was to determine whether patients treated in a geriatric evaluation and management unit (GEMU) had a more appropriate drug profile than patients treated in the general medical wards (MW). METHODS: Frail elderly patients admitted as emergencies to the medical department were randomised to treatment in the GEMU (n=127) or MW (n=127). Drugs used at inclusion and discharge were registered retrospectively and analysed with regard to polypharmacy, number of drugs withdrawn or started, potential drug-drug interactions (DDIs), number of anticholinergic drugs prescribed, and the number of inappropriate drug prescriptions according to Beers' criteria. Utilisation of psychotropic and cardiovascular drugs was compared in detail according to prespecified hypotheses. RESULTS: The number of patients with polypharmacy did not differ significantly between the GEMU and MW. The median number of scheduled drugs withdrawn per patient was higher in the GEMU than in the MW (p=0.005). Drugs with anticholinergic effects (p=0.003); cardiovascular drugs (p<0.001), particularly digitalis glycosides (p<0.001); and antipsychotic drugs (p=0.009) were withdrawn more often in the GEMU. The median number of scheduled drugs started was higher in the GEMU than in the MW (p=0.03). In particular, antidepressants (p<0.001) and estriol (p=0.001) were started more often in the GEMU than in the MW. Fewer GEMU than MW patients had potential DDIs at discharge (p=0.009). CONCLUSION: Drug treatment in the GEMU as compared with the MW was more appropriate in terms of prescription of fewer drugs with anticholinergic effects and fewer potential DDIs. There were distinct differences in treatment patterns of cardiovascular and psychotropic drugs.

Aged↗
PubMed2005

Pharmacokinetic and behavioral effects of allopregnanolone in healthy women.

RATIONALE: The behavioral effects of allopregnanolone (3alpha-hydroxy-5alpha-pregnan-20-one) in women are not known. OBJECTIVE: Allopregnanolone, a neuroactive steroid secreted by the mammalian ovary, exerts its anesthetic, anxiolytic, and sedative/hypnotic effects through potentiation of GABAA receptors. The purpose of this study was to evaluate the behavioral effects of allopregnanolone in healthy women. METHODS: Ten healthy women were given three increasing intravenous doses of allopregnanolone in the follicular phase of the menstrual cycle. Saccadic eye movement parameters and visual analogue scales of sedation were used to evaluate the behavioral response of allopregnanolone. Repeated blood samples for analyses of allopregnanolone were drawn throughout the study day. RESULTS: Exogenously administered allopregnanolone decreases saccadic eye movement parameters and increases subjective ratings of sedation that correlate with increased serum concentrations of this neuroactive steroid. CONCLUSION: The behavioral effects of allopregnanolone are similar to that of its 5beta-stereoisomer, pregnanolone (3alpha-hydroxy-5beta-pregnan-20-one). Apart from fatigue and mild nausea, allopregnanolone given in a cumulative dose of 0.09 mg/kg did not have any adverse effects.

Adult↗
PubMed2005

[Are mood stabilizers beneficial in the treatment of schizophrenia?].

BACKGROUND: Antipsychotic agents are the drugs of choice in the treatment of schizophrenia. However, some patients profit only modestly from such therapy and thus represent a clinical challenge. MATERIAL AND METHODS: This article is based upon a review of relevant literature on treatment with the mood stabilizers lithium, carbamazepine, valproate and lamotrigine in patients with schizophrenia. RESULTS: Few well-designed studies exist on the use of mood stabilizers in schizophrenia. In monotherapy, these drugs have no documented beneficial effect, but when used as adjunct therapies to antipsychotics, some positive effects are described. Best evidence for an anti-aggressive effect exists for lithium, but it is described also for carbamazepine. Lithium also has some effects on affective symptoms. Valproate has not shown a consistently positive effect. Lamotrigine has demonstrated a beneficial effect in a placebo-controlled study, but this finding should be verified by others before its place in the treatment of schizophrenia can be established. INTERPRETATION: Mood stabilizers are not the drugs of choice in the treatment of schizophrenia but could be considered as potential adjuncts to antipsychotics in patients with treatment-resistant schizophrenia, although the documentation is sparse.

Antimanic Agents↗
PubMed2005

[COX-2 inhibitors--one step forward and two steps back].

BACKGROUND: Selective cyclooxygenase-2 (COX-2) inhibitors are widely used. They have no advantages in terms of efficacy, and it is not documented that they cause fewer adverse effects than conventional NSAIDs. MATERIAL AND METHODS: The adverse effects of rofecoxib, celecoxib and other NSAIDs are reviewed. Relevant literature was identified on Medline and in the reference lists in key articles. RESULTS: Rofecoxib and the novel COX-2 inhibitors etoricoxib and valdecoxib have a higher degree of COX-2 selectivity than traditional NSAIDs. Celecoxib is less COX-2 selective and appears to be similar to diclofenac. Rofecoxib induces thromboembolic adverse effects more frequently than conventional NSAIDs. INTERPRETATION: The cardiovascular problems conferred by rofecoxib are probably a class effect and thus inducible by other selective COX-2 inhibitors. Pending comprehensive safety data, caution is warranted regarding the use of these drugs.

Anti-Inflammatory Agents, Non-Steroidal↗