Reversal Strategies for NOACs: State of Development, Possible Clinical Applications and Future Perspectives.


:The non-vitamin K antagonist oral anticoagulants (NOACs) are used for thromboembolic prophylaxis of patients with atrial fibrillation and in the treatment as well as secondary prophylaxis of patients with venous thromboembolism. Even though NOACs have a better safety profile than vitamin K antagonists (VKAs), there will still be bleeding complications on NOAC treatment. In some cases, stopping the NOAC and non-drug-related management such as manual compression and interventional endoscopy will be sufficient to stop the bleeding. In more serious bleeding events and before acute surgery, coagulation factor concentrates or NOAC-specific antidotes could be used. Coagulation factor concentrates can be used in patients with haemophilia and to reverse the effect of VKAs but, in NOAC-treated patients, results are inconsistent and these agents could potentially have pro-thrombotic effects. Specific antidotes for NOACs are expected to be on the market soon. Phase III clinical trials with a humanized antibody fragment directed against dabigatran (idarucizumab) and recombinant, modified factor Xa (andexanet alfa) are ongoing. A molecule (aripazine) with broad activity against various anticoagulants including NOACs is currently undergoing phase II trials. For use of these specific antidotes, it is desirable that measurements for coagulation activity with a short response delay are widely available for the different NOACs and further research in this field is needed. Furthermore, guidelines for antidote use, including general measures for the treatment of NOAC-related bleeding, should be available.


Drug Saf


Drug safety


Husted S,Verheugt FW,Comuth WJ




Has Abstract


2016-01-01 00:00:00














  • Drug treatment of depression in HIV-positive patients : safety considerations.

    abstract::Safe and effective treatment of major depression, one of the most common comorbid conditions in individuals infected with HIV, significantly lowers morbidity and mortality from HIV disease. However, optimal treatment of both conditions is complicated by interactions between the disease processes as well as the pharmac...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Pieper AA,Treisman GJ

    更新日期:2005-01-01 00:00:00

  • Drug therapy for acute ischaemic stroke: risks versus benefits.

    abstract::Stroke is a very common medical emergency that, until recently, had no specific treatment. Following the results of several major trials (including 2 'mega-trials'), aspirin (acetylsalicylic acid) can be recommended for the majority of patients with acute ischaemic stroke. While the benefit of aspirin is only modest, ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Lindley RI

    更新日期:1998-11-01 00:00:00

  • Renal effects of peptic ulcer therapy.

    abstract::Drugs used in the treatment of peptic ulcer disease may interact with the renal system in a variety of ways. Since many agents are eliminated by renal excretion, clearance of these agents may be reduced and half-life extended in the presence of renal insufficiency. The histamine H2-receptor antagonists may interfere w...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Burgess E,Muruve D

    更新日期:1992-07-01 00:00:00

  • Detection of adverse drug events and other treatment outcomes using an electronic prescribing system.

    abstract:BACKGROUND:Current pharmacosurveillance methods do not provide timely information on drug safety and effectiveness. Real-time surveillance using electronic prescribing systems could address this problem; however, the data collected using these systems has not been validated. We investigated the accuracy of using orders...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Eguale T,Tamblyn R,Winslade N,Buckeridge D

    更新日期:2008-01-01 00:00:00

  • Benefit-risk assessment of zaleplon in the treatment of insomnia.

    abstract::Insomnia is a heterogeneous, highly prevalent condition that is associated with a high level of psychiatric, physical, social and economic morbidity. The treatment of insomnia involves pharmacological and non-pharmacological interventions. The mainstay of pharmacological treatment of insomnia has been the benzodiazepi...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Barbera J,Shapiro C

    更新日期:2005-01-01 00:00:00

  • What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects.

    abstract::Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at ...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: van Eekeren R,Rolfes L,Koster AS,Magro L,Parthasarathi G,Al Ramimmy H,Schutte T,Tanaka D,van Puijenbroek E,Härmark L

    更新日期:2018-11-01 00:00:00

  • Immunisation and type 1 diabetes mellitus: is there a link?

    abstract::Recent evidence from animal studies has raised the possibility that immunisation by vaccines can influence the pathogenesis of type I (insulin-dependent) diabetes mellitus. In non-obese diabetic mice and biobreeding rats, complete Freund's adjuvant and bacillus Calmette-Guérin (BCG) vaccine have successfully been used...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Hiltunen M,Lönnrot M,Hyöty H

    更新日期:1999-03-01 00:00:00

  • Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis.

    abstract:INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang F

    更新日期:2019-07-01 00:00:00

  • Benefit-risk assessment of dronedarone in the treatment of atrial fibrillation.

    abstract::Rhythm control in atrial fibrillation (AF) can be achieved using pharmacological therapy. Amiodarone is the most efficacious anti-arrhythmic agent; however, its use is limited due to an unfavourable safety profile, including pro-arrhythmia, thyroid, liver, skin and pulmonary complications. Dronedarone, which is struct...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Adlan AM,Lip GY

    更新日期:2013-02-01 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


    authors: Yamaoka K

    更新日期:2016-09-01 00:00:00

  • Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab.

    abstract::Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Jackson DJ,Korn S,Mathur SK,Barker P,Meka VG,Martin UJ,Zangrilli JG

    更新日期:2020-05-01 00:00:00

  • Hydroxyurea in the treatment of HIV infection: clinical efficacy and safety concerns.

    abstract::Data from basic science and clinical studies suggest that hydroxyurea (hydroxycarbamide)-based regimens are effective treatment options for patients with HIV at various stages of disease. In vitro studies of HIV-infected lymphocytes have shown that hydroxyurea: (i) inhibits viral DNA synthesis; (ii) synergistically in...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Lisziewicz J,Foli A,Wainberg M,Lori F

    更新日期:2003-01-01 00:00:00

  • Nature, occurrence and consequences of medication-related adverse events during hospitalization: a retrospective chart review in the Netherlands.

    abstract:BACKGROUND:Medication-related adverse events (MRAEs) form a large proportion of all adverse events in hospitalized patients and are associated with considerable preventable harm. Detailed information on harm related to drugs administered during hospitalization is scarce. Knowledge of the nature and preventability of MR...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Hoonhout LH,de Bruijne MC,Wagner C,Asscheman H,van der Wal G,van Tulder MW

    更新日期:2010-10-01 00:00:00

  • National ADR Monitoring System in China.

    abstract::It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstra...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Hou Y,Li X,Wu G,Ye X

    更新日期:2016-11-01 00:00:00

  • Discontinuation of beta-blockers and the risk of myocardial infarction in the elderly.

    abstract:BACKGROUND:It has been shown that the abrupt cessation of treatment with beta-adrenoceptor antagonists (beta-blockers) increases the risk of myocardial infarction in patients with hypertension. As beta-blockers differ in their pharmacokinetic and pharmacodynamic properties, this risk of discontinuation might also diffe...

    journal_title:Drug safety

    pub_type: 临床试验,杂志文章


    authors: Teichert M,de Smet PA,Hofman A,Witteman JC,Stricker BH

    更新日期:2007-01-01 00:00:00

  • Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

    abstract:INTRODUCTION:Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Belleudi V,Trotta F,Addis A,Ingrasciotta Y,Ientile V,Tari M,Gini R,Pastorello M,Scondotto S,Cananzi P,Traversa G,Davoli M,Trifirò G,Italian Biosimilar Network (ItaBioNet).

    更新日期:2019-12-01 00:00:00

  • Nonsteroidal anti-inflammatory drugs and reversible female infertility: is there a link?

    abstract::Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed to women of child-bearing age. Three case series highlight the possibility of a link between NSAIDs and reversible infertility. The pharmacological target of NSAIDs is cyclo-oxygenase (COX), which catalyses the first rate-limiting step in the prod...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Stone S,Khamashta MA,Nelson-Piercy C

    更新日期:2002-01-01 00:00:00

  • Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease.

    abstract::Although the aetiology of inflammatory bowel disease remains elusive, many agents are available for the control of symptoms and inflammation. Knowledge of drug pharmacology, indications and side effects is essential to ensure the best possible clinical care while minimising toxicity and inappropriate use. Sulfasalazin...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Hanauer SB,Stathopoulos G

    更新日期:1991-05-01 00:00:00

  • Drug-induced severe skin reactions. Incidence, management and prevention.

    abstract::Severe skin adverse drug reactions can result in death, but the rate of such events is fortunately low. The incidences of Stevens-Johnson syndrome and toxic epidermal necrolysis range from 1.2 to 6 per million per year and 0.4 to 1.2 per million per year, respectively. Stevens-Johnson syndrome is fatal in about 5% and...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Wolkenstein P,Revuz J

    更新日期:1995-07-01 00:00:00

  • Drug therapy and the older person: role of the pharmacist.

    abstract::Older people in the UK receive a disproportionate amount of medication. They comprise 18% of the population but receive 45% of all prescription items. Not surprisingly they experience drug-related illnesses - in 1980, 1 in 10 admissions to acute geriatric units were wholly or partly due to adverse drug reactions. Drug...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Denham MJ,Barnett NL

    更新日期:1998-10-01 00:00:00

  • Adverse effects and drug interactions of clinical importance with antiviral drugs.

    abstract::Most antiviral drugs are nucleoside analogues with potential teratogenic, embryotoxic, carcinogenic and antiproliferative activities. They must be administered with caution during pregnancy, because some are known teratogens (e.g. amantadine) and a similar propensity cannot be entirely excluded for others (e.g. aciclo...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Morris DJ

    更新日期:1994-04-01 00:00:00

  • Benefit-risk assessment of rofecoxib in the treatment of osteoarthritis.

    abstract::NSAIDs are widely used to treat pain and inflammation in osteoarthritis. Their use in this indication is generally intermittent and fluctuates with the intensity of the disease. Nonetheless, success of the therapy is frequently limited by injury to the gastrointestinal mucosa and complications such as bleeding, ulcera...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Schmidt H,Woodcock BG,Geisslinger G

    更新日期:2004-01-01 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


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

    更新日期:2010-12-01 00:00:00

  • Adverse effects of coumarin anticoagulants.

    abstract::The biochemistry of vitamin K metabolism and the role of vitamin K-dependent gamma-carboxylation of the vitamin K-dependent coagulation factors are now well understood. Likewise, there is a clear understanding of the role of oral anticoagulants in the inhibition of these coagulation factors. However, the effect of ora...

    journal_title:Drug safety

    pub_type: 杂志文章,评审


    authors: Pineo GF,Hull RD

    更新日期:1993-10-01 00:00:00

  • Performance of probabilistic method to detect duplicate individual case safety reports.

    abstract:BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

    更新日期:2014-04-01 00:00:00

  • Bias in benefit-risk appraisal in older products: the case of buflomedil for intermittent claudication.

    abstract::Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: De Backer TL,Vander Stichele RH,Van Bortel LM

    更新日期:2009-01-01 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


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

    更新日期:2007-01-01 00:00:00

  • An algorithmic computerised order entry approach to assist in the prescribing of new therapeutic agents: case study of activated protein C at an academic medical centre.

    abstract:BACKGROUND:Academic medical centres face the need to care for patients with complex medical conditions, educate physicians-in-training and conduct research, all with increasingly constrained budgets. The adoption of new therapeutic technology presents challenges and opportunities in each of these areas. Severe sepsis r...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Fischer MA,Lilly CM,Churchill WW,Baden LR,Avorn J

    更新日期:2004-01-01 00:00:00

  • All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study.

    abstract:INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...

    journal_title:Drug safety

    pub_type: 杂志文章


    authors: Jeong S,Tchoe HJ,Li J,Shin JY

    更新日期:2019-06-01 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


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

    更新日期:1994-09-01 00:00:00