Evaluation of Serious Adverse Drug Reactions
Archives of Internal MedicinePublished 28 May 2007
Charles L. Bennett
Citations53
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
Proactive safety efforts conducted by the RADAR investigators are more comprehensive than those conducted byThe FDA and pharmaceutical manufacturers, but dissemination of related safety notifications is less timely.
Abstract
Proactive safety efforts conducted by the RADAR investigators are more comprehensive than those conducted by the FDA and pharmaceutical manufacturers, but dissemination of related safety notifications is less timely.
Keywords
MathematicsEconomics, Econometrics and FinancePharmacology, Toxicology and Pharmaceutics
Clinical Pharmacology & TherapeuticsA method for estimating the probability of adverse drug reactions
11,628 Citations1981C. A. Naranjo, U. Busto +7 more
It was shown that the ADR probability scale has consensual, content, and concurrent validity and may be applicable to postmarketing drug surveillance.
JAMAIncidence of Adverse Drug Reactions in Hospitalized Patients
4,782 Citations1998Jason Lazarou, Bruce Pomeranz +1 more
The incidence of serious and fatal adverse drug reactions in US hospitals was found to be extremely high, and data suggest that ADRs represent an important clinical issue.
The LancetAdverse drug reactions: definitions, diagnosis, and management
2,972 Citations2000I. Ralph Edwards, Jeffrey K Aronson
An adverse drug reaction is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.
HepatologyAcetaminophen‐induced acute liver failure
1,909 Citations2005Anne M. Larson, Julie Polson +9 more
In conclusion, acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States, and education of patients, physicians, and pharmacies to limit high‐risk use settings is recommended.
JAMATiming of New Black Box Warnings and Withdrawals for Prescription Medications
1,004 Citations2002Karen E. Lasser
To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market, Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999 is examined.
Annals of Internal MedicineClarifying Adverse Drug Events: A Clinician's Guide to Terminology, Documentation, and Reporting
785 Citations2004Jonathan R. Nebeker, Paul Barach +1 more
The case of an actual patient is used as a framework to explain the recognition, treatment, documentation, and reporting of drug-related harm and to provide context for the more clinically useful term adverse drug reaction.
Survey of AnesthesiologyIncidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-Analysis of Prospective Studies
676 Citations1999Jason Lazarou, Bruce Pomeranz +1 more
New England Journal of MedicineThrombotic Thrombocytopenic Purpura Associated with Clopidogrel
645 Citations2000Charles L. Bennett, Jean M. Connors +10 more
Thrombotic thrombocytopenic purpura can occur after the initiation of clopidogrel therapy, often within the first two weeks of treatment, and Physicians should be aware of the possibility of this syndrome when initiating clopIDogrel treatment.
Journal of the American College of CardiologyHypersensitivity Cases Associated With Drug-Eluting Coronary Stents
608 Citations2005Jonathan R. Nebeker, Renu Virmani +16 more
New England Journal of MedicineFailing the Public Health — Rofecoxib, Merck, and the FDA
589 Citations2004Eric J. Topol
On September 30, 2004, after more than 80 million patients had taken rofecoxib and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes.
New England Journal of MedicinePure Red-Cell Aplasia and Epoetin Therapy
428 Citations2004Charles L. Bennett, Stefano Luminari +16 more
After interventions designed in response to drug-monitoring programs worldwide resulted in a reduction of more than 80 percent in the incidence of pure red-cell aplasia due to Eprex, the exposure-adjusted incidence decreased by 83 percent worldwide.
Annals of Internal MedicineThrombotic Thrombocytopenic Purpura Associated with Ticlopidine: A Review of 60 Cases
428 Citations1998Charles L. Bennett, Peter D. Weinberg +4 more
New England Journal of MedicineOutpatient Gatifloxacin Therapy and Dysglycemia in Older Adults
367 Citations2006Laura Park‐Wyllie, David N. Juurlink +7 more
The use of gatifloxacin among outpatients is associated with an increased risk of in-hospital treatment for both hypoglycemia and hyperglycemia, regardless of the presence or absence of diabetes.
JAMAContraindicated Use of Cisapride
255 Citations2000Walter Smalley, Deborah Shatin +8 more
The FDA's 1998 regulatory action regarding cisapride use had no material effect on contraindicated cisap Ride use and more effective ways to communicate new information about drug safety are needed.
New England Journal of MedicineCOX-2 Inhibitors — Lessons in Drug Safety
241 Citations2005Bruce M. Psaty, Curt D. Furberg
Findings confirmed the increased risk of myocardial infarction previously seen in the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial4 and some observational studies.
New England Journal of MedicineCOX-2 Inhibitors — A Lesson in Unexpected Problems
199 Citations2005Jeffrey M. Drazen
This issue of the Journal contains three articles about the adverse cardiovascular effects of agents that selectively inhibit one form of prostaglandin endoperoxide synthase, commonly known as cyclooxygenase-2 (COX-2).
Leukemia ResearchGemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): An overview from the research on adverse drug events and reports (RADAR) project
176 Citations2006June M. McKoy, Cara Angelotta +10 more
Caution is advised when administering GO in routine clinical practice, particularly if administered with other hepatotoxic agents, at doses and schedules more intensive than those approved by the FDA, or within 3 months of a SCT procedure.
HepatologyAcetaminophen‐induced acute liver failure
167 Citations2006William J. Holubek, Susanne Kalman +1 more
The recent observation of a hepatotoxic adverse event in patients treated with CCR5 inhibitors is consistent with experimental observations and must be kept in mind for the future use of C CR5 inhibitors.
JAMAThalidomide- and Lenalidomide-Associated Thromboembolism Among Patients With Cancer
146 Citations2006Charles L. Bennett, Cara Angelotta +5 more
British Journal of HaematologyHaematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) project
132 Citations2006Charles L. Bennett, Andrew M. Evens +13 more
While a causal relationship with haematological malignancies cannot be demonstrated, long‐term follow‐up among healthy individuals who receive haem atopoietic growth factors is needed.
JAMAHow the US Drug Safety System Should Be Changed
130 Citations2006Brian L. Strom
The current system of drug safety monitoring will be described and the limitations of the current system will be highlighted and a potential solution will then be proposed that will require legislation to implement.
JAMAThe Research on Adverse Drug Events and Reports (RADAR) Project
124 Citations2005Charles L. Bennett
JAIDS Journal of Acquired Immune Deficiency SyndromesSerious Adverse Cutaneous and Hepatic Toxicities Associated With Nevirapine Use by Non???HIV-Infected Individuals
124 Citations2004Shilpa M. Patel, Stuart Johnson +4 more
Serious hepatic and cutaneous toxicities can occur in non–HIV-infected individuals who receive short-term nevirapine therapy and the use of PEP regimens containing ne virapine should be discouraged.
StrokeClopidogrel-Associated TTP
115 Citations2004Anaadriana Zakarija, Nicholas Bandarenko +11 more
Completeness, timeliness, and certainty of diagnosis were best for cases obtained by active surveillance, intermediate for cases reported to the pharmaceutical supplier, and poorest forcases reported directly to the FDA.
New England Journal of MedicinePopulation-Based Studies of Adverse Drug Effects
98 Citations2003Wayne A. Ray
The prescription of medications has long been the most frequent therapeutic intervention in medicine and in 2000 in the United States, 173 million people filled 2.2 billion outpatient prescriptions, a record high.
New England Journal of MedicineExpecting the Unexpected — Drug Safety, Pharmacovigilance, and the Prepared Mind
86 Citations2004Anne Trontell
A large number of the patients treated in these trials had no prior history of depression, and it is likely that these patients did not have a history of mental health problems prior to their treatment with the drug.
New England Journal of MedicineProtecting the Health of the Public — Institute of Medicine Recommendations on Drug Safety
83 Citations2006Bruce M. Psaty, Sheila Burke
The IOM committee assessed the U.S. drug-safety system and identified a number of serious problems, including a lack of clear regulatory authority, chronic underfunding, organizational difficulties, and a scarcity of post-approval data.
The American Journal of MedicineThalidomide-associated deep vein thrombosis and pulmonary embolism
82 Citations2002Charles L. Bennett, Glen T. Schumock +5 more
Clinical details of patients who developed thalidomide-associated thromboembolic events are reported to report oncology trials initiated when studies found that thalidOMide is a modestly potent angiogenesis inhibitor.
Archives of Internal MedicineThe FDA and Drug Safety
82 Citations2006Curt D. Furberg
Congress is urged to give the FDA more direct legal authority to pursue violations, authorize the adoption of a conditional drug approval policy, and mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety.
Archives of Internal MedicineAdherence to Black Box Warnings for Prescription Medications in Outpatients
81 Citations2006Karen E. Lasser, Diane L. Seger +8 more
In an observational study of 51 outpatient practices using an electronic health record, the frequency with which patients received prescriptions in violation of black box warnings for drug-drug, drug-laboratory, and/or drug-disease interactions was measured.
Clinical Pharmacology & TherapeuticsComparison of the Bayesian approach and a simple algorithm for assessment of adverse drug events*
81 Citations1995Krista L. Lanctôt, Claudio A. Naranjo
The APS may be an effective screening tool, although BARDI can better discriminate drug from nondrug‐induced cases and may be more appropriate for serious cases of adverse drug reactions.
The LancetDangers of rosuvastatin identified before and after FDA approval
75 Citations2004Sidney M. Wolfe
CancerClinical features and correlates of gemcitabine‐associated lung injury
66 Citations2006Steven M. Belknap, Timothy M. Kuzel +5 more
New England Journal of MedicineThrombotic Thrombocytopenic Purpura and Clopidogrel — A Need for New Approaches to Drug Safety
61 Citations2000Alastair J.J. Wood
The evidence linking clopidogrel to the development of thrombotic throm bocytopenic purpura is strengthened by the finding that the disorder began within 14 days after the initiation of clopIDogrel therapy in all but one patient.
JAMAAdverse Effects Associated With Use of Nevirapine in HIV Postexposure Prophylaxis for 2 Health Care Workers
45 Citations2000Beverly E. Sha
Annals of Internal MedicineHepatotoxicity after Prophylaxis with a Nevirapine-Containing Antiretroviral Regimen
38 Citations2002Stuart Johnson, Juliana Chan +1 more
Pharmacoepidemiology and Drug SafetyCommunicating safety information to physicians: an examination of dear doctor letters
35 Citations2005Kathleen M. Mazor, Susan E. Andrade +3 more
This study examined whether content, organization, and formatting of dear doctor letters (DDLs) influences physicians' responses to the letters.
New England Journal of MedicineSerious Adverse Drug Effects — Seeing the Trees through the Forest
26 Citations2006Jerry H. Gurwitz
The authors describe the findings of two population-based, nested case–control studies involving outpatients 66 years of age or older who had received treatment with various broad-spectrum antibiotics regarding the association of the fluoroquinolone gatifloxacin with dysglycemia.
PubMedPost-cardiac catheterization access site complications and low-molecular -weight heparin following cardiac catheterization.
26 Citations2003Lee MacDonald, Sheridan N. Meyers +5 more
In patients receiving standard dose enoxaparin after percutaneous invasive cardiac procedures, there is the potential for delayed and severe access site hemorrhagic and vascular complications.
Australian Journal of OpthalmologyTHE NATIONAL REGISTRY OF DRUG‐INDUCED OCULAR SIDE EFFECTS
3 Citations1984Frederick T. Fraunfelder, S. M. MEYER BS
The National Registry of Drug-induced Ocular Side Effects is an international information centre for ocular toxicology that collects case reports of drug-induced ocular side effects from physicians and other national registries, and surveys the world literature for drug-related ocular events.