Oral contraceptives and venous thromboembolism: a systematic review and meta-analysis.

Abstract:

BACKGROUND:An association between oral contraceptive (OC) use and venous thromboembolism (VTE) has long been recognized. However, no summary estimates of the increase in VTE risk associated with OC use have been available since 1995, and no meta-analyses have evaluated the VTE risk of new preparations containing drospirenone. OBJECTIVE:The aim of the study was to carry out a meta-analysis to summarize existing evidence on the association between venous VTE and OC use, and to investigate how such an association may vary according to the type of OC, OC user characteristics, study characteristics and biases. METHODS:Relevant cohort or case-control studies were searched in MEDLINE and other electronic databases up to May 2010, with no language restriction. Data were combined using a generic inverse-variance approach. Meta-regression in addition to stratification was used to explore potential predictors of the summary estimate of risk. RESULTS:Sixteen cohort and 39 case-control studies were included in at least one comparison. Overall, the odds ratio (OR) of OC users versus non-users was 3.41 (95% CI 2.98, 3.92). This estimate was based upon nine cohort studies evaluating approximately 12 000 000 person-years, and 23 case-control studies including approximately 45 000 women. VTE risk for OC users was significantly lower in studies evaluating 'all VTE cases' than in those evaluating 'idiopathic VTE only' (OR 3.09 and 4.94, respectively). Among the carriers of genetic mutations G20210A and Factor V Leiden (FVL), OC users showed a significantly increased VTE risk compared with non-users (OR 1.63; 95% CI 1.01, 2.65, and OR 1.80; 95% CI 1.20, 2.71, respectively). When the newest OCs containing drospirenone were compared with non-drospirenone-containing OCs (except those containing levonorgestrel only), VTE risk did not significantly increase (OR 1.13; 95% CI 0.94, 1.35). CONCLUSIONS:This meta-analysis confirms that OC use significantly increases VTE risk. The strength of this association, however, varies according to the generation of OC, type of outcome and presence of a genetic mutation, with ORs ranging from 3 to 5.

journal_name

Drug Saf

journal_title

Drug safety

authors

Manzoli L,De Vito C,Marzuillo C,Boccia A,Villari P

doi

10.2165/11598050-000000000-00000

subject

Has Abstract

pub_date

2012-03-01 00:00:00

pages

191-205

issue

3

eissn

0114-5916

issn

1179-1942

journal_volume

35

pub_type

杂志文章,meta分析,评审
  • Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials.

    abstract:INTRODUCTION:Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE:Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psyc...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-017-0623-1

    authors: Thai-Cuarto D,O'Brien CF,Jimenez R,Liang GS,Burke J

    更新日期:2018-04-01 00:00:00

  • Benefits and risks of pharmacological agents used for the treatment of menorrhagia.

    abstract::Menorrhagia affects the lives of many women. The assessment of menstrual flow is highly subjective and gauging the severity of the condition by objective assessment of menstrual blood loss is impractical. In treating menorrhagia, the primary aim should be to improve quality of life. Women are willing to undergo quite ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200427020-00001

    authors: Roy SN,Bhattacharya S

    更新日期:2004-01-01 00:00:00

  • Safety of efalizumab therapy in patients with moderate to severe psoriasis: an open-label extension of a phase IIIb trial.

    abstract:BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombi...

    journal_title:Drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.2165/00002018-200831080-00008

    authors: Hamilton T,Menter A,Caro I,Compton P,Sobell J,Papp KA

    更新日期:2008-01-01 00:00:00

  • Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles.

    abstract:BACKGROUND:The use of data mining has increased among regulators and pharmaceutical companies. The incremental value of data mining as an adjunct to traditional pharmacovigilance methods has yet to be demonstrated. Specifically, the utility in identifying new safety signals and the resources required to do so have not ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11319000-000000000-00000

    authors: Bailey S,Singh A,Azadian R,Huber P,Blum M

    更新日期:2010-02-01 00:00:00

  • Risks and benefits of drugs used in the management of the hyperactive child.

    abstract::Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199309010-00004

    authors: Fox AM,Rieder MJ

    更新日期:1993-07-01 00:00:00

  • Evaluation of risk profiles for gastrointestinal and cardiovascular adverse effects in nonselective NSAID and COX-2 inhibitor users: a cohort study using pharmacy dispensing data in The Netherlands.

    abstract:BACKGROUND:Newly approved drugs, in comparison with older drugs, are more often prescribed to patients who have not responded satisfactorily to established related drugs or as first-line therapy to patients with a high baseline risk for adverse outcomes (i.e. channelling). However, these patients are less likely to ben...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200831020-00004

    authors: Layton D,Souverein PC,Heerdink ER,Shakir SA,Egberts AC

    更新日期:2008-01-01 00:00:00

  • Monitoring adverse events of the vaccination campaign against influenza A (H1N1) in the Netherlands.

    abstract:BACKGROUND:In November 2009, a vaccination campaign against Influenza A (H1N1) was started in the Netherlands. The accelerated registration procedure of the vaccines used in this campaign and the use of these vaccines on a large scale indicated a need for real-time safety monitoring. OBJECTIVE:To describe the processi...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11539270-000000000-00000

    authors: van Puijenbroek EP,Broos N,van Grootheest K

    更新日期:2010-12-01 00:00:00

  • Spontaneous adverse drug reaction reporting in rural districts of Mozambique.

    abstract:BACKGROUND:The roll out of various public health programmes involving mass administration of medicines calls for the deployment of responsive pharmacovigilance systems to permit identification of signals of rare or even common adverse reactions. In developing countries in Africa, these systems are mostly absent and the...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200831100-00005

    authors: Sevene E,Mariano A,Mehta U,Machai M,Dodoo A,Vilardell D,Patel S,Barnes K,Carné X

    更新日期:2008-01-01 00:00:00

  • Management of osteoporosis and Paget's disease. An appraisal of the risks and benefits of drug treatment.

    abstract::Osteoporosis is a major public health problem occurring primarily among the postmenopausal population. Osteoporosis is a preventable disease, but despite several advances in its prevention, treatment of the established disease to date remains a major challenge to be managed by primary care physicians. Stabilisation of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199411030-00004

    authors: Gennari C,Nuti R,Agnusdei D,Camporeale A,Martini G

    更新日期:1994-09-01 00:00:00

  • Antihyperlipidaemic agents. Drug interactions of clinical significance.

    abstract::The available antihyperlipidaemic drugs are generally safe and effective, and major systemic adverse effects are uncommon. However, because of their complex mechanisms of action, careful monitoring is required to identify and correct potential drug interactions. Bile acid sequestrants are the most difficult of these a...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199411050-00002

    authors: Farmer JA,Gotto AM Jr

    更新日期:1994-11-01 00:00:00

  • Benefit and Risk of Tofacitinib in the Treatment of Rheumatoid Arthritis: A Focus on Herpes Zoster.

    abstract::The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-016-0430-0

    authors: Yamaoka K

    更新日期:2016-09-01 00:00:00

  • The use of analgesics in patients with asthma.

    abstract::Aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) cause deterioration in respiratory function in approximately 10% of adults with asthma and a smaller proportion of children with asthma. We propose evidence-based guidelines for the safe use of NSAIDs in individuals with asthma foll...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200124110-00004

    authors: Levy S,Volans G

    更新日期:2001-01-01 00:00:00

  • Predictors and timing of adverse experiences during trandsdermal nicotine therapy.

    abstract:OBJECTIVES:Difficulty sleeping is a recognised tobacco withdrawal symptom, but sleep problems, like application site reactions, are commonly reported as adverse reactions to transdermal nicotine therapy. However, no studies have examined potential predictive factors associated with the occurrence of expected adverse ex...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-199920060-00007

    authors: Gourlay SG,Forbes A,Marriner T,McNeil JJ

    更新日期:1999-06-01 00:00:00

  • Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices.

    abstract::Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-020-01030-2

    authors: Huysentruyt K,Kjoersvik O,Dobracki P,Savage E,Mishalov E,Cherry M,Leonard E,Taylor R,Patel B,Abatemarco D

    更新日期:2021-02-01 00:00:00

  • Neuropsychiatric complications of antiretroviral therapy.

    abstract::Neuropsychiatric adverse effects related to potent antiretroviral therapy are among the complications that can lead to poor adherence, treatment interruptions, or change of antiretroviral therapy regimens. For a historical perspective, we review early literature and case reports with CNS adverse effects attributed to ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200629100-00004

    authors: Cespedes MS,Aberg JA

    更新日期:2006-01-01 00:00:00

  • Serious events with infliximab in patients with inflammatory bowel disease: a 9-year cohort study in the Netherlands.

    abstract:BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/0002018-200831120-00009

    authors: de Vries HS,van Oijen MG,de Jong DJ

    更新日期:2008-01-01 00:00:00

  • A risk-benefit assessment of therapies for Lennox-Gastaut syndrome.

    abstract::The treatment of Lennox-Gastaut syndrome has been improved for some patients by the introduction of adjunctive therapy with newer anticonvulsants such as lamotrigine and topiramate and the availability of vagal nerve stimulation and the re-emergence of the use of the ketogenic diet in recent years. The place of standa...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200022060-00005

    authors: Schmidt D,Bourgeois B

    更新日期:2000-06-01 00:00:00

  • A risk-benefit assessment of anti-obesity drugs.

    abstract::This review evaluates the benefits and potential health risks of the currently used drugs that are approved for the pharmacological treatment of obesity. Analysis of several long term clinical trials indicates that all of these drugs are efficient in reducing excess bodyweight, and that the majority of them allow the ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199920020-00003

    authors: Kolanowski J

    更新日期:1999-02-01 00:00:00

  • Non-medicinal ingredients.

    abstract::Many drug products contain excipients which perform important functions in terms of stability, solubility and identification. Excipients should not be considered as inactive ingredients, as they have been associated with a wide range of adverse reactions in some individuals. Monitoring for excipient toxicity is import...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199000051-00015

    authors: Scott AW

    更新日期:1990-01-01 00:00:00

  • Community Pharmacists' Views and Experiences with ADR Reporting for Complementary Medicines: A Qualitative Study in New Zealand.

    abstract:INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-020-00980-x

    authors: Barnes J,Butler R

    更新日期:2020-11-01 00:00:00

  • Use of triage strategies in the WHO signal-detection process.

    abstract::An important role for the WHO Programme for International Drug Monitoring is to identify signals of international drug safety problems as early as possible. Since 1998, Bayesian Confidence Propagation Neural Network (BCPNN) data mining has been in routine use for screening of the WHO adverse reaction database, Vigibas...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200730070-00014

    authors: Lindquist M

    更新日期:2007-01-01 00:00:00

  • Allergic reactions to medicines derived from Pelargonium species.

    abstract::Pelargonium (Pelargonium sidoides DC and P. reniforme Curtis) is reported to have immune modulating properties and antibacterial activity, and Pelargonium extracts have been used for the treatment of respiratory tract and gastrointestinal infections. Introduced in the early 1980s in Germany, Umckaloabo (ISO Arzneimitt...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200730080-00004

    authors: de Boer HJ,Hagemann U,Bate J,Meyboom RH

    更新日期:2007-01-01 00:00:00

  • Cytokine-induced autoimmune disorders.

    abstract::Cytokines are now commonly used in the treatment of many conditions, especially cancer, haematological malignancies and chronic viral hepatitis. With some of these cytokines, clinical induction and/or exacerbation of autoimmune manifestations have been observed. This has been the case with interferon-alpha and interfe...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717020-00002

    authors: Miossec P

    更新日期:1997-08-01 00:00:00

  • Today's challenges in pharmacovigilance: what can we learn from epoetins?

    abstract::Highly publicized safety issues of medicinal products in recent years and the accompanying political pressure have forced both the US FDA and the European Medicines Agency (EMA) to implement stronger regulations concerning pharmacovigilance. These legislative changes demand more proactive risk management strategies of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/11586350-000000000-00000

    authors: Ebbers HC,Mantel-Teeuwisse AK,Moors EH,Schellekens H,Leufkens HG

    更新日期:2011-04-01 00:00:00

  • Prevalence of potentially severe drug-drug interactions in ambulatory patients with dyslipidaemia receiving HMG-CoA reductase inhibitor therapy.

    abstract:BACKGROUND:Drug-drug interactions (DDIs) are a well known risk factor for adverse drug reactions. HMG-CoA reductase inhibitors ('statins') are a cornerstone in the treatment of dyslipidaemia and patients with dyslipidaemia are concomitantly treated with a variety of additional drugs. Since DDIs are associated with adve...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200528030-00007

    authors: Rätz Bravo AE,Tchambaz L,Krähenbühl-Melcher A,Hess L,Schlienger RG,Krähenbühl S

    更新日期:2005-01-01 00:00:00

  • Validation of multivariate outlier detection analyses used to identify potential drug-induced liver injury in clinical trial populations.

    abstract:BACKGROUND:Potential severe liver injury is identified in clinical trials by ALT >3 × upper limits of normal (ULN) and total bilirubin >2 × ULN, and termed 'Hy's Law' by the US FDA. However, there is limited evidence or validation of these thresholds in clinical trial populations. Using liver chemistry data from clinic...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/BF03261982

    authors: Lin X,Parks D,Painter J,Hunt CM,Stirnadel-Farrant HA,Cheng J,Menius A,Lee K

    更新日期:2012-10-01 00:00:00

  • A benefit-risk assessment of misoprostol for cervical ripening and labour induction.

    abstract::Misoprostol, a prostaglandin E(1) analogue, is widely used in the US and other countries for cervical ripening and labour induction. Its use for these indications is not approved by the US Food and Drug Administration (FDA). The manufacturer of misoprostol issued a letter to American healthcare providers in August 200...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200225090-00005

    authors: Wing DA

    更新日期:2002-01-01 00:00:00

  • Vancomycin-Induced Thrombocytopenia: A Narrative Review.

    abstract::Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-016-0469-y

    authors: Mohammadi M,Jahangard-Rafsanjani Z,Sarayani A,Hadjibabaei M,Taghizadeh-Ghehi M

    更新日期:2017-01-01 00:00:00

  • Risk of diabetic ketoacidosis after exposure to risperidone or olanzapine.

    abstract:BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200730070-00004

    authors: Ramaswamy K,Kozma CM,Nasrallah H

    更新日期:2007-01-01 00:00:00

  • Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK.

    abstract:BACKGROUND:Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would m...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11318940-000000000-00000

    authors: Anton C,Cox AR,Ferner RE

    更新日期:2009-01-01 00:00:00