Evaluation of dabigatran bleeding adverse reaction reports in the FDA adverse event reporting system during the first year of approval.

Abstract:

STUDY OBJECTIVE:Evaluate dabigatran adverse event reports with a reported bleeding event and/or reported fatal outcome compared with warfarin. DESIGN:Retrospective analysis of the FDA Adverse Event Reporting System (FAERS) database. MEASUREMENTS AND MAIN RESULTS:We identified reports from October 1, 2010, through December 31, 2011, in the United States listing dabigatran or warfarin as the primary suspected agent. Bleeding events and related outcomes were determined. A bleeding-related mortality rate was calculated based on national dabigatran treatment data. RESULTS:Dabigatran was the primary suspected agent in 9029 adverse reports. Of these, 2347 (26%) were bleeding events; a fatal outcome was reported in 348 (15%) of the bleeding events. In comparison, warfarin was the suspected agent in 2038 reports, of which 647 (32%) were reported as bleeding events. Among the warfarin bleeding reports, 46 (7.1%) reported a fatal outcome. Based on national dabigatran use and adverse bleed reports with fatal outcomes, we estimate a lower bound of 150 bleeding-related fatalities per 100,000 dabigatran patient-years. Because of underreporting bias, these estimates represent a lower bound on the population bleeding mortality rates. CONCLUSION:Reports from FAERS are subject to significant bias but suggest that fatal outcomes among dabigatran reports are higher in clinical practice than they were in controlled clinical trials.

journal_name

Pharmacotherapy

journal_title

Pharmacotherapy

authors

McConeghy KW,Bress A,Qato DM,Wing C,Nutescu EA

doi

10.1002/phar.1415

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

561-9

issue

6

eissn

0277-0008

issn

1875-9114

journal_volume

34

pub_type

杂志文章
  • Clinical use of anti-epidermal growth factor receptor monoclonal antibodies in metastatic colorectal cancer.

    abstract::Abstract Cetuximab and panitumumab, monoclonal antibodies used to target the epidermal growth factor receptor (EGFR), were recently approved by the United States Food and Drug Administration for use as single agents or in combination with other chemotherapy drugs in the treatment of metastatic colorectal cancer. The a...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1592/phco.28.11-supp.31S

    authors: Patel DK

    更新日期:2008-11-01 00:00:00

  • Use of Newer Anticonvulsants for the Treatment of Status Epilepticus.

    abstract::Status epilepticus (SE) has a high mortality rate and is one of the most common neurologic emergencies. Fast progression of this neurologic emergency and lack of response to traditional antiepileptic drugs (AEDs) in most cases has challenged clinicians to use new agents. This article evaluates the efficacy and safety ...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.2229

    authors: Farrokh S,Bon J,Erdman M,Tesoro E

    更新日期:2019-03-01 00:00:00

  • Association of GGH Promoter Methylation Levels with Methotrexate Concentrations in Chinese Children with Acute Lymphoblastic Leukemia.

    abstract:BACKGROUND:It is known that γ-glutamyl hydrolase (GGH) is involved in the disposition of methotrexate (MTX), and GGH activity is regulated by DNA methylation in acute lymphoblastic leukemia (ALL) cells. The present study explores the methylation status of the GGH promoter in peripheral blood and its association with MT...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1002/phar.2430

    authors: Wang SM,Kong XY,Li M,Sun LL,Yan D

    更新日期:2020-07-01 00:00:00

  • Dalbavancin and Oritavancin: An Innovative Approach to the Treatment of Gram-Positive Infections.

    abstract::Health care-associated infections, especially those caused by multidrug-resistant gram-positive organisms, such as methicillin-resistant Staphylococcus aureus (MRSA), are a growing public health threat. In 2014, the U.S. Food and Drug Administration approved two new lipoglycopeptides, oritavancin and dalbavancin, for ...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.1641

    authors: Roberts KD,Sulaiman RM,Rybak MJ

    更新日期:2015-10-01 00:00:00

  • Salary survey of ambulatory care clinical pharmacists.

    abstract::To determine salary and selected fringe benefits of members of the Ambulatory Care Practice and Research Network of the American College of Clinical Pharmacy, we developed a self-administered questionnaire that surveyed demographic information, schooling and training, academic appointments, yearly salary (as of Februa...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:

    authors: Anastasio GD,Shaughnessy AF

    更新日期:1997-05-01 00:00:00

  • Benzocaine-induced methemoglobinemia in two patients: interdisciplinary collaboration, management, and near misses.

    abstract::Methemoglobin, a form of hemoglobin that does not bind oxygen, is produced when iron in red blood cells is oxidized from the ferrous state to the ferric state. Methemoglobinemia develops in the presence of oxidizing agents, such as benzocaine-containing topical anesthetic sprays, and it is characterized by cyanosis. I...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1592/phco.27.8.1206

    authors: Throm MJ,Stevens MD,Hansen C

    更新日期:2007-08-01 00:00:00

  • Adjunctive aerosolized antibiotics for treatment of ventilator-associated pneumonia.

    abstract:STUDY OBJECTIVE:To determine clinical and microbiologic success in patients receiving adjunctive aerosolized antibiotics for the treatment of ventilator-associated pneumonia (VAP). DESIGN:Retrospective medical record review. SETTING:Level I trauma intensive care unit of a large academic medical center. PATIENTS:Fort...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1592/phco.29.9.1054

    authors: Czosnowski QA,Wood GC,Magnotti LJ,Croce MA,Swanson JM,Boucher BA,Fabian TC

    更新日期:2009-09-01 00:00:00

  • Dapagliflozin: a novel sodium-glucose cotransporter type 2 inhibitor for the treatment of type 2 diabetes mellitus.

    abstract::The prevalence of diabetes mellitus has grown to staggering numbers, and its incidence is expected to rise in the next 2 decades. The need for novel approaches to treat hyperglycemia cannot be ignored. Current agents have been shown to modestly improve glycemia and in some cases prevent complications of diabetes, but ...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/PHAR.1010

    authors: Shah NK,Deeb WE,Choksi R,Epstein BJ

    更新日期:2012-01-01 00:00:00

  • Is there a risk of bleeding associated with standardized Ginkgo biloba extract therapy? A systematic review and meta-analysis.

    abstract:STUDY OBJECTIVE:To determine the effect of standardized Ginkgo biloba leaf extracts (GBE) on outcome parameters of hemostasis associated with risk of bleeding. DESIGN:Meta-analysis of 18 randomized controlled trials. SUBJECTS:A total of 1985 adults were enrolled to receive either GBE or placebo; 87% were patients wit...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,meta分析,评审

    doi:10.1592/phco.31.5.490

    authors: Kellermann AJ,Kloft C

    更新日期:2011-05-01 00:00:00

  • Clinical implications of vancomycin heteroresistant and intermediately susceptible Staphylococcus aureus.

    abstract::Staphylococcus aureus (S. aureus) has proven to be a major pathogen with the emergence of methicillin-resistant S. aureus (MRSA) infections and recently with heteroresistant vancomycin-intermediate S. aureus (hVISA) and vancomycin-intermediate S. aureus (VISA) infections. Although vancomycin is traditionally a first-l...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.1577

    authors: Gomes DM,Ward KE,LaPlante KL

    更新日期:2015-04-01 00:00:00

  • Limitations of traditional anticoagulants.

    abstract::Warfarin and unfractionated heparin have been in clinical use for more than 50 years. Both are effective anticoagulants, but their use is associated with a number of impediments, including the need for intensive coagulation monitoring, wide variation in dose-response relationships, multiple drug interactions (in the c...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1592/phco.24.10.62s.36120

    authors: Hawkins D

    更新日期:2004-07-01 00:00:00

  • Appropriateness of iron prescribing: a retrospective study.

    abstract::We retrospectively reviewed the charts of 120 patients who received an initial prescription of iron from a resident physician in internal medicine to determine how accurately house officers diagnose iron-deficiency anemia before initiating iron therapy. Each patient's laboratory records were reviewed for the 3-month p...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:

    authors: Abernathy KA,Meuleman JR

    更新日期:1996-05-01 00:00:00

  • Use of novel antipsychotic drugs.

    abstract::The atypical antipsychotic agents clozapine and risperidone bring new insight into the care and treatment of patients with schizophrenia. Since their introduction, several names (e.g., novel, atypical, serotonergic-dopaminergic antagonist) have been used to describe the nature of these compounds. The agents are unique...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:

    authors: Raleigh F

    更新日期:1996-11-01 00:00:00

  • High-performance capillary electrophoresis in the pharmaceutical sciences.

    abstract::High-performance capillary electrophoresis (HPCE) is a new separation technique that is applied in the pharmaceutical sciences. Separations by HPCE occur in a narrow-bore capillary under the influence of an applied electrical field. Components of the sample matrix are separated and migrate at different rates based on ...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:

    authors: Brunner LJ,DiPiro JT,Feldman S

    更新日期:1995-01-01 00:00:00

  • Pharmacology and therapeutic use of low-dose dopamine.

    abstract::The renal pharmacologic effects of intravenous dopamine in doses of 0.5-3.0 micrograms/kg/min include increases in renal blood flow, glomerular filtration rate, solute excretion, and urine flow. Clinical studies revealed that low-dose dopamine can reverse oliguria, but these studies were poorly controlled, were confou...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/j.1875-9114.1986.tb03492.x

    authors: Dasta JF,Kirby MG

    更新日期:1986-11-01 00:00:00

  • Successful management of anticoagulation therapy during international travel.

    abstract::Warfarin is considered a high-risk drug because of its narrow therapeutic window, variability in dose response, and multitude of drug and food interactions. Although travel advice is available for patients who are taking warfarin, it is geared toward patients who are traveling to developed countries and tends to be la...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1002/j.1875-9114.2012.01019.x

    authors: Truong T,Armor BL

    更新日期:2012-03-01 00:00:00

  • Octreotide-Associated Neutropenia.

    abstract::Drug-induced neutropenia and agranulocytosis are rare adverse events but can be fatal. Neutropenia can be induced by a myriad of drugs from almost every pharmacologic class. Octreotide is a somatostatin analog that has been used to treat variceal bleeding, acromegaly, and severe diarrhea associated with metastatic tum...

    journal_title:Pharmacotherapy

    pub_type:

    doi:10.1002/phar.1942

    authors: Tse SS,Kish T

    更新日期:2017-06-01 00:00:00

  • Clinical and microbiologic analysis of a hospital's extended-spectrum beta-lactamase-producing isolates over a 2-year period.

    abstract:STUDY OBJECTIVE:To evaluate the microbiologic and clinical outcomes of patients with extended-spectrum beta-lactamase (ESBL)-producing isolates over a 2-year period. DESIGN:Retrospective analysis. SETTING:Tertiary care teaching hospital. PATIENTS:Twenty-one patients with cultures of confirmed ESBL-producing Escheric...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1592/phco.23.12.1232.32706

    authors: Burgess DS,Hall RG 2nd,Lewis JS 2nd,Jorgensen JH,Patterson JE

    更新日期:2003-10-01 00:00:00

  • Atorvastatin calcium: an addition to HMG-CoA reductase inhibitors.

    abstract::Atorvastatin calcium is an HMG-coenzyme A (CoA) reductase inhibitor that was approved by the Food and Drug Administration on December 17, 1996. Like other such agents, it inhibits the action of HMG-CoA reductase and thereby decreases endogenous cholesterol synthesis, leading to a decrease in circulating low-density li...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:

    authors: Chong PH,Seeger JD

    更新日期:1997-11-01 00:00:00

  • Discrepancies in identification of major bleeding events in patients taking warfarin.

    abstract:STUDY OBJECTIVE:To assess the level of agreement between one subjective definition of major bleeding (criteria A) and two objective definitions: the International Society on Thrombosis and Haemostasis ([ISTH] criteria B) and the Italian Study of Complications of Anticoagulant Therapy ([ISCOAT] criteria C). DESIGN:Retr...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1592/phco.28.9.1098

    authors: Seto AC,Kenyon K,Wittkowsky AK

    更新日期:2008-09-01 00:00:00

  • Evidence of the economic benefit of clinical pharmacy services: 1996-2000.

    abstract::We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1592/phco.23.1.113.31910

    authors: Schumock GT,Butler MG,Meek PD,Vermeulen LC,Arondekar BV,Bauman JL,2002 Task Force on Economic Evaluation of Clinical Pharmacy Services of the American College of Clinical Pharmacy.

    更新日期:2003-01-01 00:00:00

  • Association Between Time-in-Therapeutic Tacrolimus Range and Early Rejection After Heart Transplant.

    abstract:BACKGROUND:Historically, there is perceived pressure to achieve therapeutic levels of tacrolimus quickly after heart transplant (HT). We evaluated the association between time within therapeutic tacrolimus range and time to therapeutic trough and rejection in the 30 days following HT. METHODS:This is a single-center r...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:10.1002/phar.2262

    authors: Baker WL,Steiger S,Martin S,Patel N,Radojevic J,Darsaklis K,O'Bara L,Kutzler H,Dougherty J,Feingold A,Hammond J,Fusco D,Gluck JA

    更新日期:2019-05-01 00:00:00

  • Pharmacotherapy of behavioral and psychological symptoms of dementia: time for a different paradigm?

    abstract::Behavioral and psychological symptoms of dementia can occur in 60-80% of patients with Alzheimer's disease or other dementing illnesses, and are important in that they are a source of significant caregiver stress and often precipitate nursing home placement. These symptoms, namely, aggression, delusions, hallucination...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1592/phco.21.1.74.34437

    authors: Rojas-Fernandez CH,Lanctot KL,Allen DD,MacKnight C

    更新日期:2001-01-01 00:00:00

  • Methotrexate in rheumatoid arthritis: an update.

    abstract::Methotrexate, a folic acid antagonist, is being employed more frequently in an attempt to control rheumatoid arthritis that has not responded adequately to conventional therapies. Systemic administration of 7.5-15 mg weekly in a pulse fashion appears to be effective without precipitating serious adverse effects. Conce...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/j.1875-9114.1986.tb03472.x

    authors: Miller DR,Letendre PW,DeJong DJ,Fiechtner JJ

    更新日期:1986-07-01 00:00:00

  • Patient drug attributions and postmarketing surveillance.

    abstract::Although studies have shown that patients can distinguish probable adverse drug reactions (ADRs) from adverse clinical events (ACEs) caused by other factors, it is not known whether these attribution judgments add any independent validity to other accepted methods of identifying ADRs, such as physician assessments or ...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章

    doi:

    authors: Fisher S,Bryant SG,Kent TA,Davis JE

    更新日期:1994-03-01 00:00:00

  • Aspirin for primary prevention of cardiovascular disease events.

    abstract::Aspirin has been used for the prevention and treatment of cardiovascular disease (CVD) for several decades. The efficacy of aspirin for secondary prevention of cardiovascular disease is well established, but the clinical benefit of aspirin for primary prevention of CVD is less clear. The primary literature suggests th...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.1127

    authors: Nemerovski CW,Salinitri FD,Morbitzer KA,Moser LR

    更新日期:2012-11-01 00:00:00

  • Sublingual administration of tacrolimus: current trends and available evidence.

    abstract::Widespread anecdotal use of sublingual tacrolimus administration has arisen, although little literature exists to guide practice. Given the paucity of data, we conducted a survey to evaluate the practice of sublingual tacrolimus administration at transplant centers across the United States and evaluated the literature...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.1492

    authors: Doligalski CT,Liu EC,Sammons CM,Silverman A,Logan AT

    更新日期:2014-11-01 00:00:00

  • Warfarin Pharmacogenomics in Diverse Populations.

    abstract::Genotype-guided warfarin dosing algorithms are a rational approach to optimize warfarin dosing and potentially reduce adverse drug events. Diverse populations, such as African Americans and Latinos, have greater variability in warfarin dose requirements and are at greater risk for experiencing warfarin-related adverse...

    journal_title:Pharmacotherapy

    pub_type: 杂志文章,评审

    doi:10.1002/phar.1982

    authors: Kaye JB,Schultz LE,Steiner HE,Kittles RA,Cavallari LH,Karnes JH

    更新日期:2017-09-01 00:00:00

  • Prospective surveillance of intravenous amphotericin B use patterns.

    abstract::Information on amphotericin B use patterns and infusion-related adverse events were prospectively collected from 397 hospitalized adults. The methods of initiating amphotericin B varied greatly, with the majority of patients being gradually titrated to a full maintenance dose over 1-5 days. Overall, 71% of patients ex...

    journal_title:Pharmacotherapy

    pub_type: 临床试验,杂志文章,多中心研究,评审

    doi:

    authors: Grasela TH Jr,Goodwin SD,Walawander MK,Cramer RL,Fuhs DW,Moriarty VP

    更新日期:1990-01-01 00:00:00

  • Randomized, multicenter comparison of oral granisetron and oral ondansetron for emetogenic chemotherapy.

    abstract:STUDY OBJECTIVES:To compare the antiemetic effectiveness and safety of oral granisetron plus dexamethasone with those of oral ondansetron plus dexamethasone administered before emetogenic chemotherapy. DESIGN:Randomized, prospective, multicenter, open-label study. SETTINGS:University-teaching hospital and veterans he...

    journal_title:Pharmacotherapy

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1592/phco.20.17.1318.34894

    authors: Herrington JD,Kwan P,Young RR,Lagow E,Lagrone L,Riggs MW

    更新日期:2000-11-01 00:00:00