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https://www.readbyqxmd.com/read/29215916/new-and-incremental-fda-black-box-warnings-from-2008-to-2015
#1
Michael T Solotke, Sanket S Dhruva, Nicholas S Downing, Nilay D Shah, Joseph S Ross
BACKGROUND: The boxed warning (also known as "black box warning [BBW]") is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. METHODS: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites...
December 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28804147/ismp-adverse-drug-reactions-levofloxacin-induced-neuroexcitation-and-hallucinations-statin-induced-muscle-rupture-mefloquine-induced-rhabdomyolysis-methimazole-induced-cholestatic-hepatitis-decitabine-induced-hand-and-foot-syndrome
#2
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
May 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28515502/ismp-adverse-drug-reactions-pregabalin-induced-stuttering-nitroglycerine-induced-bradycardia-progressing-to-asystole-minocycline-induced-dress-leading-to-liver-transplantation-and-type-1-diabetes-increased-risk-of-vertebral-fractures-in-women-receiving-thiazide
#3
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
April 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28439130/ismp-adverse-drug-reactions
#4
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
March 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28371826/development-of-an-automated-assessment-tool-for-medwatch-reports-in-the-fda-adverse-event-reporting-system
#5
Lichy Han, Robert Ball, Carol A Pamer, Russ B Altman, Scott Proestel
Objective: As the US Food and Drug Administration (FDA) receives over a million adverse event reports associated with medication use every year, a system is needed to aid FDA safety evaluators in identifying reports most likely to demonstrate causal relationships to the suspect medications. We combined text mining with machine learning to construct and evaluate such a system to identify medication-related adverse event reports. Methods: FDA safety evaluators assessed 326 reports for medication-related causality...
September 1, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28367259/united-states-food-and-drug-administration-product-label-changes
#6
Leon Kircik, Julie C Sung, Linda Stein-Gold, Gary Goldenberg
Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch program. As a result, 400 to 500 label changes occur every year. Actinic keratosis treatments exemplify the commonality of label changes throughout the postmarket course of a drug...
February 2017: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/28321144/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights-october-december-2016
#7
Brenda J Rose
The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on December 31, 2016 for date range "10/1/2016-12/31/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats...
February 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28321135/ismp-adverse-drug-reactions
#8
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
February 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28179736/ismp-adverse-drug-reactions-acute-disseminated-intravascular-coagulation-due-to-oxaliplatin-azithromycin-induced-stevens-johnson-syndrome-acute-jugular-vein-thrombosis-with-rituximab-hemorrhagic-bullae-of-the-fingers-induced-by-furosemide
#9
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
January 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28057955/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights-july-september-2016
#10
Teresa Rubio
The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on October 10, 2016 for date range "7/1/2016-9/30/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats...
December 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/28057946/ismp-adverse-drug-reactions-sildenafil-induced-erythema-multiforme-acute-liver-injury-due-to-febuxostat-intravenous-acetaminophen-induced-acute-hepatotoxicity-acute-transient-myopia-induced-by-zanamivir-lidocaine-induced-hoigne-syndrome
#11
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
December 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27928184/ismp-adverse-drug-reactions-chronic-marijuana-use-associated-with-recurrent-diabetic-ketoacidosis-lamotrigine-induced-cataplexy-trimethoprim-sulfamethoxazole-induced-hyponatremia-ziprasidone-induced-sleepwalking-and-sleep-related-eating-metabolic-acidosis-associated
#12
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
November 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27729671/ziprosidone-induced-transient-agranulocytosis-delayed-onset-of-cardiac-adverse-effects-with-fingolimod-telmisartan-induced-myotoxicity-severe-dilated-cardiomyopathy-induced-by-adalimumab-and-ustekinumab
#13
EDITORIAL
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
November 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/27698510/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights
#14
Cristina Whalen Klafehn
As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted...
September 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27698499/ipilimumab-induced-polyneuropathy-ibuprofen-induced-allergic-type-liver-injury-trimethoprim-sulfamethoxazole-induced-immune-thrombocytopenia-in-children-mesna-induced-fixed-drug-eruption-digoxin-induced-ocular-toxicity
#15
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
September 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27668367/big-data-and-pharmacovigilance-the-role-of-oncology-nurses
#16
David G Glenn
When new anticancer medications are approved, their safety profiles are often not fully understood. Oncology nurses have a responsibility to file reports of adverse drug events with safety registries such as MedWatch. If these registries receive prompt, complete, and accurate data from clinicians, agencies such as the U.S. Food and Drug Administration will have a stronger ability to detect hazards and to issue safety recommendations.
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October 1, 2016: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/27559184/delayed-anaphylaxis-with-methimazole-nicolau-syndrome-after-oxytocin-intramuscular-administration-anastrazole-induced-autoimmune-hepatitis-amoxicillin-and-cephalexin-induced-eosinophilic-colitis-docetaxel-induced-supravenous-erythematous-eruption
#17
Michael A Mancano
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested...
July 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27454754/privacy-preserving-data-anonymization-of-spontaneous-ade-reporting-system-dataset
#18
Wen-Yang Lin, Duen-Chuan Yang, Jie-Teng Wang
BACKGROUND: To facilitate long-term safety surveillance of marketing drugs, many spontaneously reporting systems (SRSs) of ADR events have been established world-wide. Since the data collected by SRSs contain sensitive personal health information that should be protected to prevent the identification of individuals, it procures the issue of privacy preserving data publishing (PPDP), that is, how to sanitize (anonymize) raw data before publishing. Although much work has been done on PPDP, very few studies have focused on protecting privacy of SRS data and none of the anonymization methods is favorable for SRS datasets, due to which contain some characteristics such as rare events, multiple individual records, and multi-valued sensitive attributes...
July 18, 2016: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/27367536/hepatotoxicity-associated-with-weight-loss-or-sports-dietary-supplements-including-oxyelite-pro%C3%A2-united-states-2013
#19
Kevin Chatham-Stephens, Ethel Taylor, Arthur Chang, Amy Peterson, Johnni Daniel, Colleen Martin, Patricia Deuster, Rebecca Noe, Stephanie Kieszak, Josh Schier, Karl Klontz, Lauren Lewis
In September 2013, the Hawaii Department of Health (HDOH) was notified of seven adults who developed acute hepatitis after taking OxyELITE Pro™, a weight loss and sports dietary supplement. CDC assisted HDOH with their investigation, then conducted case-finding outside of Hawaii with FDA and the Department of Defense (DoD). We defined cases as acute hepatitis of unknown etiology that occurred from April 1, 2013, through December 5, 2013, following exposure to a weight loss or muscle-building dietary supplement, such as OxyELITE Pro™...
January 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27354752/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights
#20
Brenda Rose
As part of the US Food and Drug Administration's MedWatch program, safety labeling changes are reviewed and compiled monthly for drugs and therapeutic biologics where important changes have been made to the safety information. Boxed warnings (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf) are ordinarily used to highlight either adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drugs or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted...
June 2016: Hospital Pharmacy
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