FDA Warning
FDA Adds Warning of Serious Liver Injury to Menopause Drug
The FDA has added a warning of a rare occurrence of serious liver injury in patients taking the drug fezolinetant ...
OCTOBER 8, 2024

FDA Warning on Probiotics for Prevention of Necrotizing Enterocolitis Causes Shift in Care
Last fall, the FDA issued a warning letter ordering two manufacturers to stop selling probiotic products for use in ...
JUNE 4, 2024

FDA Warns of Strangulation Risk With Pediatric Enteral Feeding Tubes
Enteral feeding set tubing can become wrapped around pediatric patients’ necks, causing strangulation or ...
FEBRUARY 14, 2022

FDA Warns Providers About Prescribing Ocaliva in Patients With PBC and Advanced Cirrhosis
The FDA is warning physicians not to prescribe obeticholic acid (Ocaliva, Intercept) to patients with primary ...
MAY 27, 2021

FDA Warns of Possible Serious CV Events, Cancer Linked to Xeljanz
The FDA issued an alert concerning an increased risk for serious cardiovascular events and malignancies with the ...
FEBRUARY 6, 2021

FDA Adds Boxed Warning to Ocaliva Label to Highlight Correct Dosing
The FDA issued a Drug Safety Communication related to obeticholic acid (Ocaliva, Intercept), warning that the drug ...
FEBRUARY 2, 2018

FDA Issues Black Box Warning for HBV Reactivation
The FDA is urging DAA manufacturers to place the warning labels on their drugs.
OCTOBER 6, 2016