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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
#1
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
#2
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
#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...
September 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27668367/big-data-and-pharmacovigilance-the-role-of-oncology-nurses
#4
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
#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'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
#6
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...
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
#7
Kevin Chatham-Stephens, Ethel Taylor, Art 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™...
July 1, 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27354752/summaries-of-safety-labeling-changes-approved-by-the-fda-boxed-warnings-highlights
#8
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
https://www.readbyqxmd.com/read/27303074/gastrointestinal-nodules-and-bleeding-with-long-term-lanthanum-use-dress-and-hepatotoxicity-due-to-rivaroxaban-thrombocytopenia-induced-by-pentoxifylline-amlodipine-induced-schamberg-s-disease-varenicline-induced-acute-liver-injury
#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...
April 2016: Hospital Pharmacy
https://www.readbyqxmd.com/read/27123624/medwatch-free-patient-safety-resources
#10
Diane S Aschenbrenner
No abstract text is available yet for this article.
May 2016: American Journal of Nursing
https://www.readbyqxmd.com/read/27000172/suicidal-ideation-and-behavior-as-adverse-events-of-prescribed-medications-an-update-for-pharmacists
#11
Jill E Lavigne
OBJECTIVES: Suicide is the tenth leading cause of death in the US, and the Food and Drug Administration (FDA) has labeled more than 125 prescription drugs for potential adverse effects of suicidal ideation and behavior. Several are in the top 200 for highest dispensed volume, including the entire class of antiepileptics. Also included are drugs used to treat urinary incontinence, an antibiotic, and smoking cessation agents. We describe the importance of pharmacists' identification and management of these complex adverse events and conclude with the potential for Department of Veterans Affairs and other big data longitudinal clinical research projects to provide additional insight into the complex causes of this adverse event...
March 2016: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/26962391/united-states-food-and-drug-administration-product-label-changes
#12
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...
January 2016: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/26955658/fluoroquinolone-related-neuropsychiatric-and-mitochondrial-toxicity-a-collaborative-investigation-by-scientists-and-members-of-a-social-network
#13
Kamaljeet Kaur, Raja Fayad, Arpit Saxena, Norma Frizzell, Anindya Chanda, Suvarthi Das, Saurabh Chatterjee, Shweta Hegde, Manjeshwar Shrinath Baliga, Venkatesh Ponemone, Matthew Rorro, Jennifer Greene, Yasmine Elraheb, Alan J Redd, John Bian, John Restaino, LeAnn B Norris, Zaina P Qureshi, Bryan L Love, Brandon Brookstaver, Peter Georgantopoulos, Oliver Sartor, Dennis W Raisch, Gowtham Rao, Kevin Lu, Paul Ray, William Hrusheshky, Richard Schulz, Richard Ablin, Virginia Noxon, Charles L Bennett
BACKGROUND: The 3 fluoroquinolone (FQ) antibiotics - ciprofoxacin, levofoxacin, and moxifoxacin - are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia...
February 2016: Journal of Community and Supportive Oncology
https://www.readbyqxmd.com/read/26940554/azacitidine-induced-pericarditis-a-case-series
#14
Matthew Newman, Midhun Malla, Ivana Gojo
STUDY OBJECTIVE: To describe three cases of pericarditis probably related to azacitidine administration in a span of 3 years at our center. DESIGN: Case series. SETTING: Comprehensive cancer center within a large, academic medical center. PATIENTS: Three patients with high-grade myelodysplastic syndrome or acute myeloid leukemia who received azacitidine. INTERVENTION: None. MEASUREMENTS: None...
April 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/26912914/nonconvulsive-status-epilepticus-in-elderly-patients-receiving-ssris-euglycemic-diabetic-ketoacidosis-associated-with-canagliflozin-use-in-a-type-1-diabetic-patient-duloxetine-induced-galactorrhea-canagliflozin-associated-severe-hypercalcemia-and-hypernatremia
#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...
October 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/26715798/trimethoprim-sulfamethoxazole-induced-rhabdomyolysis-gabapentin-induced-hypoglycemia-in-diabetic-and-nondiabetic-patients-purple-glove-syndrome-after-oral-phenytoin-administration-acute-dystonic-reaction-after-methylphenidate-initiation-serotonin-syndrome-with
#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...
September 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/26635479/increasing-patient-engagement-in-pharmacovigilance-through-online-community-outreach-and-mobile-reporting-applications-an-analysis-of-adverse-event-reporting-for-the-essure-device-in-the-us
#17
Chi Y Bahk, Melanie Goshgarian, Krystal Donahue, Clark C Freifeld, Christopher M Menone, Carrie E Pierce, Harold Rodriguez, John S Brownstein, Robert Furberg, Nabarun Dasgupta
BACKGROUND: Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians...
2015: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/26449124/fda-s-medwatch-program-monitors-drug-safety-but-it-depends-on-nurses-to-report-adverse-events
#18
Deborah Miller
No abstract text is available yet for this article.
September 2015: ONS Connect
https://www.readbyqxmd.com/read/26405333/bacteremia-in-preterm-infants-receiving-probiotics-throbbing-headache-associated-with-enoxaparin-use-dress-reaction-following-isoniazid-treatment-siadh-associated-with-glimepiride-mania-associated-with-bortezomib-administration
#19
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...
June 2015: Hospital Pharmacy
https://www.readbyqxmd.com/read/26405319/high-dose-loperamide-abuse-inducing-life-threatening-cardiac-arrhythmias-topiramate-induced-diarrhea-in-a-breastfed-infant-danazol-induced-stevens-johnson-syndrome-asenapine-induced-myasthenic-syndrome-black-hairy-tongue-due-to-linezolid-adalimumab-induced
#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) Med Watch 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 2015: Hospital Pharmacy
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