Healio

Transparency or ‘unnecessary alarm’? Explaining FDA’s reporting tool for cosmetic harms

Please provide your email address to receive an email when new articles are posted on . The FDA launched a new online dashboard for reporting adverse events related to cosmetic products. This ...
UUHC Health Feed

How to Recover from Adverse Events

Health care workers face adverse events daily. These events include secondary trauma, occupational trauma, unexpected death or injury, moral injury, medical error and ...
Nature

Gastrointestinal adverse events associated with Lenvatinib versus Lenvatinib plus Pembrolizumab: A pharmacovigilance study in FDA adverse event reporting system

This study aimed to empirically analyze gastrointestinal adverse events associated with Lenvatinib monotherapy and its combination with Pembrolizumab using FDA FAERS data (January 2015-December 2023), ...
clinicaladvisor.com

FDA Now Providing Daily Updates on Adverse Events

The FDA Adverse Event Reporting System (FAERS) contains reports from health care professionals, consumers, and manufacturers on adverse events, serious medication errors, and product quality ...
Nature

Triptorelin associated adverse events evaluated using FAERS pharmacovigilance data

Triptorelin, a gonadotropin-releasing hormone(GnRH) agonist, is approved by the US Food and Drug Administration(FDA) for treating advanced prostate cancer ...
UPI

FDA to provide daily updates on adverse events

The U.S. Food and Drug Administration is now providing real-time, daily publication updates on adverse event data from its reporting system. In an effort to modernize and provide transparency on ...
FiercePharma

FDA rolls out new streamlined adverse event monitoring system, eyes $120M in savings

A new FDA adverse events monitoring system combines seven different databases across the spread of the agency's sectors, which together has cost the FDA $37 million yearly to operate. (Stock Photo ) ...
FiercePharma

FDA rolls out daily updates to adverse event dashboard, plans to further 'streamline' system

Previously, information in the FDA's FAERS dashboard was updated on a quarterly basis. (Photo By Al Drago/CQ Roll Call) As Department of Health and Human Services (HHS) and FDA leadership continue to ...
Medscape

Patient-Reported Outcome Data Enhances Reliability of Adverse Event Assessments in Cancer Care

Access to patient-reported outcome (PRO) data significantly improved providers' consistency in assessing adverse events in patients with cancer, with the greatest improvements observed for ...
Everyday Health

FDA Raises Safety Concerns About Compounded GLP-1 Weight Loss Drugs

The FDA has received hundreds of adverse event reports after people used compounded GLP-1 drugs for weight loss. Compounded GLP-1 drugs aren’t reviewed by the FDA for safety or effectiveness. The FDA ...
Healio

FDA begins daily reporting of adverse event data

Please provide your email address to receive an email when new articles are posted on . The FDA Adverse Event Reporting System will now host daily publications, instead of quarterly. The agency’s goal ...
RAPS

FDA consolidates adverse events reporting systems

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...