In September 2017 Health Canada required Janssen, the drug company responsible for Invokana and Invokamet, to send a Dear Healthcare Professional Letter — commonly referred to as a “Dear Doctor” letter — about the lower limb amputations side effect. Here are some of the points presented in this September 2017 Janssen letter to Canadian … [Read more...]
FDA Reports Show Extent And Nature of Invokana-Amputation Side Effect
A British medical journal, The Lancet Diabetes & Endocrinology, published this Correspondence item on July 18, 2017, “SGTL2 inhibitors and amputations in the US FDA Adverse Event Reporting System”. The main point of that article is set forth in this excerpt: In summary, this pharmacovigilance analysis confirms that use of canagliflozin, but … [Read more...]
Invokana Gets “Black-Box Warning” For Risk Of Leg And Foot Amputations
In the final week of July 2017, the FDA issued a notification that it had approved a revised drug label for Invokana and Invokamet, as well as a revised Medication Guide for these two diabetes drugs from Janssen Pharmaceuticals. From the most recent drug label, or Full Prescribing Information, for Invokana (accessed 7/27/17), here is the text of … [Read more...]
Can SGLT-2 Inhibitor Diabetes Drugs Increase Your Risk of Stroke?
While we have frequently discussed DKA, kidney damage, and amputations as possible side effects of diabetes drugs in the SGLT-2 inhibitors class -- such as Farxiga, Invokana, Jardiance -- strokes and thromboembolic events are also considered potential harmful effects of these drugs. Based on FAERS reports received during the second quarter of … [Read more...]
Jardiance, Invokana, And Farxiga Double Risk Of Diabetic Ketoacidosis
The June 8, 2017 edition of The New England Journal of Medicine (NEJM) has a “To the Editor” letter, titled “Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor”, which is likely causing some concerns among doctors and type 2 diabetes (T2D) patients. It is about the safety of Jardiance, Invokana, Farxiga, and other diabetes … [Read more...]
Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use
As of yesterday, May 16, 2017, the FDA issued a Drug Safety Communication regarding an increased risk of leg and foot amputations due to use of popular diabetes drugs Invokana, Invokamet, and Invokamet XR, which contain canagliflozin. These drugs belong to the sodium glucose cotransporter 2 (SGLT2) inhibitor class, and are the subjects of … [Read more...]
Farxiga MDL Includes Diabetic Ketoacidosis And Kidney Damage Lawsuits
On April 6, 2017 the United States Judicial Panel On Multidistrict Litigation (JPML) issued this document, “IN RE: FARXIGA (DAPAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION TRANSFER ORDER — MDL No. 2776”, from which we get the following information: On the basis of the papers filed and the hearing session held, we find that these actions involve … [Read more...]
Federal Court Invokana MDL In New Jersey With Judge Brian Martinotti
Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes. In December 2015 the FDA issued this Drug Safety Communication: “FDA revises labels of SGLT2 inhibitors for diabetes to include warnings … [Read more...]
EMA Warns that Some Diabetes Drugs Cause Increased Risk of Amputation
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...]