Medwatch

PURPOSE: To examine the reporting rates of adverse drug events (ADEs) with apixaban and empagliflozin as reports move up to the next level of spontaneous reporting. METHODS: This was a retrospective cohort study of outpatients who discontinued apixaban or empagliflozin within 3 years of Food and Drug Administration (FDA) approval. We enriched the sample using an active surveillance strategy to identify subsets of patients with International Classification of Diseases (ICD) codes possibly associated with an ADE...

Background: The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database. Methods: Drug data were obtained from the DRUG and OUTCOME files in the database...

BACKGROUND: Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. OBJECTIVE: The objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered. METHODS: The Food and Drug Administration's MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex® platform from Advera Health Analytics, Inc...

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. E-mail Dr. Mancano at [email protected]. Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy...

Introduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information. Methods: The reporter's occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed. Results: 96...

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. E-mail Dr. Mancano at [email protected]. Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy...

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. E-mail Dr. Mancano [email protected]). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy...

Background: Two large studies suggest that risk is not increased. But other studies have found increased risk of Alzheimer's disease and impaired cognition. Objective: To determine whether androgen deprivation therapy increases the risk of impaired cognition or Alzheimer's disease in men with prostate cancer. Methods: We used data from MedWatch, the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. Machine-readable data from MedWatch, including adverse drug reaction reports from manufacturers, are part of a public database...

OBJECTIVES: The Division of Drug Information (DDI) within the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research receives telephone calls, e-mails, and letters from patients and industry. The consistently high number of contacts about drugs in the fluoroquinolone class indicates an opportunity to increase awareness about the drugs' evolving safety profile. DATA SOURCES: Database used by DDI to summarize inquiries. SUMMARY: Inquiries about fluoroquinolones peaked in 2016 and were highest after FDA Drug Safety Communications that were issued that year...

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of revention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-ßDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with ur readers. E-mail [email protected]). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy...

BACKGROUND: Studies of Alzheimer's disease suggest that neuroinflammation or deranged brain wound healing may be a cause of some cases. But a placebo controlled study showed no effect at all on Alzheimer's disease of low dose oral prednisone after one year. Introducing the steroid directly into the hippocampus and rhinencephalon via the nose, as happens in hay fever subjects, could be more effective. OBJECTIVE: In the present study, we analyzed FDA MedWatch data for intranasal fluticasone propionate (Flonase) to determine the frequency of Alzheimer's disease as an adverse event reported after use of the medication...

Contact lenses, when worn and cared for properly, are a safe and effective form of vision correction used by an estimated 45 million Americans. However, contact lens wearers are at risk for contact lens-related eye infections, especially when wearers do not practice proper contact lens wear and care habits. These infections, affecting the cornea and known as microbial keratitis (Figure), can lead to serious adverse health outcomes. Because contact lenses are regulated by the Food and Drug Administration (FDA) as medical devices, contact lens-related corneal infections should be reported to FDA as an adverse event...

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...

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...

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: [email protected]). Your report will be published anonymously unless otherwise requested...

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...

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: [email protected]). Your report will be published anonymously unless otherwise requested...

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...

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: [email protected]). Your report will be published anonymously unless otherwise requested...

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: [email protected]). Your report will be published anonymously unless otherwise requested...