On November 15, 2017 there was an email sent by the FDA about this MedWatch Safety Alert, “Febuxostat (Brand Name Uloric): Drug Safety Communication – FDA to Evaluate Increased Risk of Heart-related Death”, from which we get this excerpt: ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk … [Read more...]
Farxiga / Jardiance / Invokana: Label Change Adds Ketoacidosis Warning
In August 2016 the FDA sent letters to Janssen Pharmaceuticals and AstraZeneca Pharmaceuticals for label changes about fatal cases of ketoacidosis cases involving Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), and Xigduo XR (dapagliflozin and metformin extended-release). As for the other diabetes … [Read more...]