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https://www.readbyqxmd.com/read/29725886/spontaneous-reporting-on-adverse-events-by-consumers-in-the-united-states-an-analysis-of-the-food-and-drug-administration-adverse-event-reporting-system-database
#1
Tadashi Toki, Shunsuke Ono
BACKGROUND: Voluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports. OBJECTIVE: The aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals. METHODS: We performed analysis on voluntary reports of AEs in the US Food and Drug Administration AE Reporting System (FAERS) database submitted in 2016...
May 3, 2018: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/29463158/the-nature-magnitude-and-reporting-compliance-of-device-related-events-for-intravenous-patient-controlled-analgesia-in-the-fda-manufacturer-and-user-facility-device-experience-maude-database
#2
Oluwadolapo D Lawal, Maitreyee Mohanty, Harrison Elder, Margie Skeer, Nathalie Erpelding, Ryan Lanier, Nathaniel Katz
BACKGROUND: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. METHODS: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016...
April 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29434381/ismp-adverse-drug-reactions-influenza-vaccine-induced-stevens-johnson-syndrome-vilazodone-induced-nightmares-dabigatran-induced-pustular-eruptions-neurotoxic-and-cardiotoxic-symptoms-after-cannabis-concentrate-exposure-rosuvastatin-induced-skin-eruption
#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) 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 2018: Hospital Pharmacy
https://www.readbyqxmd.com/read/29305342/social-media-impact-of-the-food-and-drug-administration-s-drug-safety-communication-messaging-about-zolpidem-mixed-methods-analysis
#4
Michael S Sinha, Clark C Freifeld, John S Brownstein, Macarius M Donneyong, Paula Rausch, Brian M Lappin, Esther H Zhou, Gerald J Dal Pan, Ajinkya M Pawar, Thomas J Hwang, Jerry Avorn, Aaron S Kesselheim
BACKGROUND: The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, and the public when safety issues emerge related to FDA-approved drug products. These safety messages are disseminated through social media to ensure broad uptake. OBJECTIVE: The objective of this study was to assess the social media dissemination of 2 DSCs released in 2013 for the sleep aid zolpidem. METHODS: We used the MedWatcher Social program and the DataSift historic query tool to aggregate Twitter and Facebook posts from October 1, 2012 through August 31, 2013, a period beginning approximately 3 months before the first DSC and ending 3 months after the second...
January 5, 2018: JMIR Public Health and Surveillance
https://www.readbyqxmd.com/read/29276272/ismp-adverse-drug-reactions-allergic-angina-caused-by-fluconazole-rhabdomyolysis-caused-by-risperidone-high-incidence-of-hyponatremia-with-high-dose-trimethoprim-sulfamethoxazole-lithium-carbonate-induced-hypersalivation-persistent-hemorrhage-after-idarucizumab
#5
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...
July 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/29215916/new-and-incremental-fda-black-box-warnings-from-2008-to-2015
#6
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...
February 2018: 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
#7
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
#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...
April 2017: Hospital Pharmacy
https://www.readbyqxmd.com/read/28439130/ismp-adverse-drug-reactions
#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...
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#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...
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
#18
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
#19
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
#20
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
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