FDA Adverse Event Reporting System

Antifungal dosing errors prompt FDA warningPrescribing protocols for Noxafil delayed-release tablets and oral suspension are NOT interchangeable. Errors have resulted in hospitalization and death.
FDA's Sentinel Initiative identifies drug safety problemsThe FDA's Sentinel Initiative uses big data and broad networks to detect and respond to risks associated with prescription drugs. In the June 4th Health Affairs' Health Policy Brief, the FDA describes how the Sentinel Initiative improves on the FDA's Adverse Event Reporting System (FAERS) database.
SGLT2 inhibitors for diabetes may cause ketoacidosis, FDA warnsThe FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
Incomplete AERs compromise drug safety monitoringA recent ISMP study found that the government’s adverse event reporting system is hampered by incomplete reports from manufacturers.
FDA warns of rare brain infection with MS drugAfter an MS patient died, FDA called for a description of the case to be added to the labeling for dimethyl fumarate.
Adverse effects of montelukast examined by FDA's Pediatric Advisory CommitteeAt its late September meeting, the Pediatric Advisory Committee (PAC) to the US Food and Drug Administration (FDA) said it’s time to remind healthcare professionals that Singulair (montelukast) may have adverse effects on mental and behavioral functions.