Earlier today, February 10, 2017, the European Medicines Agency (EMA) released the findings of their Pharmacovigilance Risk Assessment Committee (PRAC) concerning the link between particular diabetes drugs and an increased risk of toe amputation. These diabetes drugs are part of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of … [Read more...]
Invokana Has New Warning About Risk Of Lower Limb Amputation In Canada
We continue to monitor the drug safety regulators as well as the medical literature concerning the possible link between an increased risk of these amputations and the use of SGLT2 inhibitors such as Invokana, Invokamet, Farxiga, Xigduo XR, and Jardiance. From the Health Product InfoWatch newsletter — formerly The Canadian Adverse Reaction … [Read more...]
December 2016: FDA Requires Safety Warnings Label Change For Jardiance
After the December 2, 2016 decision by the FDA decision by U.S. regulators to expand the health benefits for the relatively new diabetes medicine Jardiance (empagliflozin) to include preventing fatal heart attacks and strokes in type 2 diabetes patients, we saw news reports about its expected effect on Jardiance sales in the U.S. From this … [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...]
Viagra, Nexium, And Invokana: Drug Injury Lawsuits Report: Summer 2016
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for patients who used the drugs listed below and developed certain side effects. (1) Erectile Dysfunction (ED) Pills, Benign Prostatic Hyperplasia (BPH) Medicines, and Pulmonary Arterial Hypertension (PAH) Medications in the … [Read more...]
Invokana / Farxiga / Jardiance: UTIs Then Urosepsis And Pyelonephritis
To date, most attention has been directed to the association between the sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs and diabetic ketoacidosis (DKA). More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect. What has received less attention, it seems, is the fact that these … [Read more...]
All SGLT2 Inhibitors Now Investigated for Increased Risk of Amputation
As discussed in my post, Are Invokana & Invokamet Linked to Increased Risk of Toe Amputations?, the European Medicines Agency (EMA) warned in April of 2016 that the popular diabetes drugs, Invokana and Invokamet (canagliflozin), were linked to an increased risk of amputations, especially of the toes. These drugs belong to the sodium glucose … [Read more...]