当前位置： SCI文献检索 > EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY期刊下所有文献 > The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals.

The use of evidence in pharmacovigilance. Case reports as the reference source for drug withdrawals.

Abstract：

OBJECTIVE:Withdrawal of a drug from the market for safety reasons is a serious and sometimes complex decision. The scientific evidence supporting drug withdrawals in the past years is critically appraised. METHODS:With data provided by the Spanish Medicines Agency, all drugs withdrawn from the Spanish market for safety reasons from January 1990 to December 1999 were identified. The adverse drug reactions (ADRs) were classified by the year of withdrawal, by the organ/system affected and by the alleged type of reaction (Rawlins and Thompson classification). A systematic review of the literature was performed. RESULTS:A total of 22 drugs were withdrawn from the market due to safety reasons. In 18 of 22 cases (82%), the evidence supporting the drug withdrawal came from individual case reports, cases series or the combination of data provided by randomised clinical trials and case reports. Hepatic (eight cases) and cardiac (five cases) reactions accounted for 59% (13 of 22) of the total withdrawals. In 10 of 22 (45%) cases, drug withdrawal was clearly due to type-B reactions. Only four withdrawals were based on evidence from observational studies including a comparison group. CONCLUSION:Case reports are the main source of information used to withdraw a drug from the market for safety reasons. It is necessary to improve the quality of evidence supporting the withdrawal process of drugs linked to unexpected and severe ADRs. The use of large databases to perform cohort or nested case-control analyses is the most efficient and reliable method to study type-A class effect ADRs. The implementation of such databases in different countries could increase the quality of the information on ADRs by allowing researchers to conduct efficiently these type of studies.

journal_name

Eur J Clin Pharmacol

journal_title

European journal of clinical pharmacology

authors

Arnaiz JA,Carné X,Riba N,Codina C,Ribas J,Trilla A

doi

10.1007/s002280100265

subject

Has Abstract

pub_date

2001-04-01 00:00:00

pages

89-91

issue

1

eissn

0031-6970

issn

1432-1041

journal_volume

57

pub_type

杂志文章,评审

相关文献

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY文献大全
  • Possible protein binding displacement interaction between glibenclamide and metolazone.

    abstract：:The effects of metolazone on the protein binding of glibenclamide were studied. It was found that increasing metolazone concentrations up to 100 ng/ml had no significant effect on the protein binding of glibenclamide studied at 10 micrograms/ml. Metolazone is unlikely to cause a clinically significant increase in the ...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00314813

    authors： George S,McBurney A,Cole A

    更新日期：1990-01-01 00:00:00

  • Do pharmacokinetic polymorphisms explain treatment failure in high-risk patients with neuroblastoma?

    abstract：PURPOSE:Neuroblastoma is the most common extracranial solid tumour in childhood. It accounts for 15% of all paediatric oncology deaths. In the last few decades, improvement in treatment outcome for high-risk patients has not occurred, with an overall survival rate <30-40%. Many reasons may account for such a low surviv...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1007/s00228-010-0966-3

    authors： Bellanti F,Kågedal B,Della Pasqua O

    更新日期：2011-05-01 00:00:00

  • Drug shortages in developed countries--reasons, therapeutic consequences, and handling.

    abstract：:Drug shortages in developed countries pose a serious public health problem and have far-reaching implications for healthcare providers and their patients. Given the current state of the market, with the limited number of manufacturers and the array of manufacturing quality issues, drug shortages have become a global c...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1007/s00228-014-1747-1

    authors： Dill S,Ahn J

    更新日期：2014-12-01 00:00:00

  • Relative immunosuppressive potency of various corticosteroids measured in vitro.

    abstract：:Natural and synthetic steroids and mineralocorticoids were tested for their in vitro suppressive activity on phytohemagglutinin (PHA) stimulated lymphocytes. Three different (p less than 0.05) groups were identified. Methylprednisolone and betamethasone were very potent, dexamethasone, hydrocortisone and prednisolone ...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00542111

    authors： Langhoff E,Ladefoged J

    更新日期：1983-01-01 00:00:00

  • Treatment-related mortality with aflibercept in cancer patients: a meta-analysis.

    abstract：PURPOSE:Aflibercept, a fully humanized vascular endothelial growth factor (VEGF)-targeted agent, has emerged as an effective therapy in the treatment of various solid tumors. We carried out an up-to-date meta-analysis to determine the risk of fatal adverse events (FAEs) in cancer patients treated with aflibercept. MET...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章,meta分析

    doi：10.1007/s00228-013-1633-2

    authors： Qi WX,Tang LN,Shen Z,Yao Y

    更新日期：2014-04-01 00:00:00

  • Measurement of 5-fluorouracil in scalp hair: a possible index of patient compliance with oral adjuvant chemotherapy.

    abstract：OBJECTIVE:Little is known about patient compliance with oral adjuvant chemotherapy. It is estimated to be poor especially in Japan, where it is still unusual for patients to be directly informed of their diagnosis of malignancy. 5-Fluorouracil (5-FU) was measured in hair samples to assess patient exposure to 5-FU, and ...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/s002280050077

    authors： Uematsu T,Nakashima M,Fujii M,Hamano K,Yasutomi M,Kodaira S,Kato T,Kotake K,Oka H,Masuike T

    更新日期：1996-01-01 00:00:00

  • The cardiovascular and central nervous system effects in the human of U-62066E. A selective opioid receptor agonist.

    abstract：:The cardiovascular and central nervous system effects of the kappa opioid receptor agonist U-62066E were investigated in ten normal male subjects who received U-62066E or placebo with low or high dose naloxone in a randomized, double blind study. Blood pressure and heart rate in the supine and standing position, plasm...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/BF00192549

    authors： Rimoy GH,Wright DM,Bhaskar NK,Rubin PC

    更新日期：1994-01-01 00:00:00

  • Population pharmacokinetic analysis of tacrolimus in the first year after pediatric liver transplantation.

    abstract：PURPOSES:Tacrolimus (TAC) is the most widely used immunosuppressant for the prevention of acute rejection after solid organ transplantation. Its pharmacokinetics (PK) show considerable variability, making TAC a good candidate for therapeutic drug monitoring (TDM). The principal aim of the study was to describe the PK o...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-013-1501-0

    authors： Guy-Viterbo V,Scohy A,Verbeeck RK,Reding R,Wallemacq P,Musuamba FT

    更新日期：2013-08-01 00:00:00

  • Influence of triazolam on thermal heat balance in poor sleepers.

    abstract：:The influence of a benzodiazepine (triazolam) on the body temperature of poor sleepers during nights disturbed by airplane noises has been examined. Subjects were divided into 3 groups each of 8 men. Following a double-blind design, Group A (controls) received a placebo for 6 consecutive nights, Group B received 0.25 ...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/BF00544042

    authors： Libert JP,Weber LD,Amoros C,Muzet A,Ehrhart J,Follenius M

    更新日期：1984-01-01 00:00:00

  • Clinical and pharmacological investigations of the new saluretic azosemid.

    abstract：:Ple 1053 (Azosemid) is a diuretic which resembles furosemide chemically and in its mode of action. When administered intravenously, Ple 1053 was approximately 5 times more potent on a weight basis than furosemide, its dose-response relationship was closer and the slope was steeper. After oral administration Ple 1053 a...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF02089953

    authors： Krück F,Bablok W,Besenfelder E,Betzien G,Kaufmann B

    更新日期：1978-11-27 00:00:00

  • Antagonism by domperidone of the ocular hypotensive effect of pergolide.

    abstract：:1. The effect of pre-dosing with 15 mg domperidone, a relatively selective dopamine 2-receptor antagonist, on the ocular hypotensive action of a single oral dose of 25 micrograms pergolide, a dopamine 2-receptor agonist, was studied in 9 normal human volunteers, using a non-invasive method. 2. Compared with domperidon...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/BF02336684

    authors： al-Sereiti MR,Quik RF,Hedges A,Turner P

    更新日期：1990-01-01 00:00:00

  • Comparison of bopindolol and atenolol in chronic stable angina pectoris.

    abstract：:The efficacy of bopindolol and atenolol in the treatment of patients with chronic stable angina pectoris have been compared in a double blind, randomized study. Both bopindolol 1 mg and atenolol 100 mg for 6 weeks increased mean exercise time (25% and 22%, respectively, compared to placebo), time to angina (27% and 25...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/BF00314809

    authors： Fitscha P,Meisner W,Tiso B

    更新日期：1990-01-01 00:00:00

  • Effects of carvedilol on common carotid arterial flow, peripheral hemodynamics, and hemorheologic variables in hypertension.

    abstract：:The effects of a beta-blocker, carvedilol, on peripheral hemodynamics and hemorheologic parameters were evaluated in 11 geriatric patients with essential hypertension [3 men and 8 women aged 62-79 years (mean, 68.6 years)]. Carvedilol was given orally after breakfast at a dose of 10 or 20 mg daily for 8 weeks. Periphe...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF01409478

    authors： Nagakawa Y,Akedo Y,Kaku S,Orimo H

    更新日期：1990-01-01 00:00:00

  • Effect of intervention promoting a reduction in antibiotic prescribing by improvement of diagnostic procedures: a prospective, before and after study in general practice.

    abstract：OBJECTIVE:To investigate if an intervention aimed at improving the quality of the diagnostic procedures in Spanish general practice could lower antibiotic prescribing in patients with respiratory tract infections (RTIs). METHODS:GPs in the intervention group (n=17) registered all patients with RTIs during a 3-week per...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-006-0187-y

    authors： Bjerrum L,Cots JM,Llor C,Molist N,Munck A

    更新日期：2006-11-01 00:00:00

  • The use of a cyclosporin-ketoconazole combination: making renal transplantation affordable in developing countries.

    abstract：OBJECTIVES:The costs of immunosuppressive drugs in renal transplant recipients remains prohibitively high. Ketoconazole (KZ) has, in limited studies, been shown to significantly reduce the dose of cyclosporin (CyA) after renal transplantation. We report our long-term experience with the use of KZ in a large group of re...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-004-0745-0

    authors： Gerntholtz T,Pascoe MD,Botha JF,Halkett J,Kahn D

    更新日期：2004-05-01 00:00:00

  • Influence of posture on pharmacokinetics.

    abstract：INTRODUCTION:Body position may influence physiological characteristics, such as perfusion, gastrointestinal function and plasma volume. These characteristics may interact with key factors determining the pharmacokinetics of drugs (dissolution, absorption, distribution, metabolism, excretion). OBJECTIVES:Based on a sys...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1007/s00228-008-0579-2

    authors： Queckenberg C,Fuhr U

    更新日期：2009-02-01 00:00:00

  • Surveillance of suspected adverse reactions to herbal products used as laxatives.

    abstract：AIM:To describe and evaluate spontaneous reports of suspected adverse reactions (ARs) associated with herbal laxatives received by the Italian Medicines Agency and the Italian National Institute of Health between April 2002 and January 2011. METHODS:Spontaneous reports of suspected ARs were individually analyzed by a ...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-011-1128-y

    authors： Vitalone A,Menniti-Ippolito F,Raschetti R,Renda F,Tartaglia L,Mazzanti G

    更新日期：2012-03-01 00:00:00

  • Relationship between recommended chronic heart failure treatments and mortality over 8 years in real-world conditions: a pharmacoepidemiological study.

    abstract：PURPOSE:We previously reported that chronic heart failure (CHF) treatments reduce the duration of hospitalisation, even in elderly patients. The present study aimed to determine whether CHF treatment also provides long-term benefits in terms of reduced mortality at 8 years. METHODS:A cohort of 281 patients who were ad...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-012-1400-9

    authors： Maison P,Desamericq G,Hemery F,Elie N,Del'volgo A,Dubois-Randé JL,Hittinger L,Macquin-Mavier I

    更新日期：2013-04-01 00:00:00

  • The influence of fenflumizole on platelet aggregation in patients with unstable angina pectoris.

    abstract：:We have studied the antiaggregatory effect of fenflumizole, a new non-steroidal antiinflammatory imidazole derivative, in ten patients with unstable angina pectoris. We have measured the aggregation induced by arachidonic acid (AA), ADP, and collagen, and serum or plasma concentrations of beta-thromboglobulin (beta-TG...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1007/BF00606628

    authors： Grauholt AM,Grande P,Wadt J

    更新日期：1987-01-01 00:00:00

  • Effect of ethanol intake on disopyramide elimination by healthy volunteers.

    abstract：:The effect of ethanol intake on disopyramide elimination was examined in an open crossover study in six healthy volunteers. No effect of ethanol on the elimination half-life or total body clearance of disopyramide was found, although it did decrease the percentage of mono-N-dealkylated disopyramide excreted in the uri...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00544024

    authors： Olsen H,Bredesen JE,Lunde PK

    更新日期：1983-01-01 00:00:00

  • Effects of grapefruit juice on the stereoselective disposition of nicardipine in humans: evidence for dominant presystemic elimination at the gut site.

    abstract：OBJECTIVES:To assess relative roles of the intestinal and hepatic stereoselective metabolism of nicardipine in an oral first-pass disposal with and without grapefruit juice intake. METHODS:The kinetic profiles of (+)- and (-)-nicardipine were studied in the six normal healthy male volunteers who received oral (40 mg) ...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1007/s002280000235

    authors： Uno T,Ohkubo T,Sugawara K,Higashiyama A,Motomura S,Ishizaki T

    更新日期：2000-12-01 00:00:00

  • Use of cimetidine; parallels and discrepancies between the views of drug regulatory agencies and practicing physicians.

    abstract：:The use of cimetidine in general practice was studied in relation to the guidelines approved by the Dutch National Drug Regulatory Agency (DRA). National and regional figures showed that the frequency with which cimetidine was prescribed in general practice was greater than could be explained on the basis of approved ...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00542346

    authors： Haayer FM,van der Werf GT,Wieringa NF,Wesseling H

    更新日期：1983-01-01 00:00:00

  • The influence of ascites on the pharmacokinetics of piretanide in cirrhotic patients.

    abstract：:The pharmacokinetics of piretanide, a new loop diuretic, were studied in seven patients with severe liver disease before and after resolution of ascites. The time to maximum concentration was significantly prolonged by the presence of ascites. Tmax after relief of ascites was similar to that seen for normal volunteers...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/BF00544070

    authors： Shepherd AN,Bouchier IA

    更新日期：1985-01-01 00:00:00

  • High frequency of mutations related to impaired CYP2C9 metabolism in a Caucasian population.

    abstract：OBJECTIVE:To search for ethnic variability in the impact of cytochrome P450 2C9 (CYP2C9) polymorphism. METHODS:CYP2C9 allelic variants related to impaired CYP2C9 metabolism were analysed in genomic DNA from 157 Spanish healthy subjects using amplification-restriction and sequencing procedures. RESULTS:The frequency f...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/s002280100264

    authors： García-Martín E,Martínez C,Ladero JM,Gamito FJ,Agúndez JA

    更新日期：2001-04-01 00:00:00

  • CYP2C19 polymorphism effect on phenobarbitone. Pharmacokinetics in Japanese patients with epilepsy: analysis by population pharmacokinetics.

    abstract：OBJECTIVE:The aim of this study was to clarify the effect of genetic polymorphisms of CYP2C19 on the pharmacokinetics of phenobarbitone (PB) using a nonlinear mixed-effects model (NONMEM) analysis in Japanese adults with epilepsy. METHODS:A total of 144 serum PB concentrations were obtained from 74 subjects treated wi...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1007/s002280050703

    authors： Mamiya K,Hadama A,Yukawa E,Ieiri I,Otsubo K,Ninomiya H,Tashiro N,Higuchi S

    更新日期：2000-02-01 00:00:00

  • Individualized aminophylline therapy in patients with obstructive airway disease: oral dosage prediction from an intravenous test dose.

    abstract：:Theophylline disposition after an intravenous test dose of aminophylline was determined in 83 subjects: 7 patients with and 58 without congestive heart failure (CHF), and 18 healthy controls. Based on the pharmacokinetics of theophylline in the individual, the oral dosage of aminophylline was scheduled to attain stead...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00545964

    authors： Horai Y,Ishizaki T,Sasaki T,Watanabe M,Kabe J

    更新日期：1982-01-01 00:00:00

  • The effect of operational stressors on ibuprofen pharmacokinetics.

    abstract：PURPOSE:To determine whether two of the major operational stressors associated with military missions in Afghanistan: dry heat and long durations of soldier patrol (SP), alter the pharmacokinetics of ibuprofen. METHODS:Thirteen healthy and physically fit participants (19-32 years) were randomized to a four-arm crossov...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/s00228-012-1307-5

    authors： Boscarino C,Edginton AN,Peng H,Riggs KW,Szeitz A,Cheung B

    更新日期：2013-01-01 00:00:00

  • Pharmacokinetics and pharmacodynamics of desmopressin administered orally versus intravenously at daytime versus night-time in healthy men aged 55-70 years.

    abstract：OBJECTIVE:To investigate (1) the pharmacokinetic and pharmacodynamic profiles of desmopressin in men from an age group with a high incidence of nocturia; and (2) circadian variation in the pharmacokinetic parameters. METHODS:The study had an open, randomised, four-way cross-over design. Desmopressin was administered o...

    journal_title：European journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1007/s00228-004-0781-9

    authors： Rembratt A,Graugaard-Jensen C,Senderovitz T,Norgaard JP,Djurhuus JC

    更新日期：2004-08-01 00:00:00

  • An analysis of the clinical development of drugs in Norway for the year 2000: the completion of research and publication of results.

    abstract：OBJECTIVE:In Norway, very little data are available on the relation between the total number of research projects on the clinical development of drugs that have been started, the number of these projects in which the research phase has been completed and the number of projects for which results have been published. The...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/s00228-008-0601-8

    authors： Hole OP,Nitter-Hauge S,Cederkvist HR,Winther FO

    更新日期：2009-03-01 00:00:00

  • Pharmacokinetics of metipranolol in normal man.

    abstract：:The pharmacokinetic parameters of deacetyl metipranolol were determined after i.v. infusion of increasing doses (6-25mg) in 17 normal volunteers. In a second cross-over trial, deacetyl metipranolol 10 and 20mg were infused in a further 10 subjects, and in a third trial another 20 volunteers received metipranolol 40mg ...

    journal_title：European journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1007/BF00637616

    authors： Abshagen U,Betzien G,Kaufmann B,Endele G

    更新日期：1982-01-01 00:00:00