Johnson & Johnson's, the drug manufacturer of diabetes drugs Invokana, Invokamet, and Invokamet XR, recently submitted a supplemental new drug application (sNDA) to the FDA to request expansion of the labels for these drugs. If granted, the new label would include a cardiovascular indication concerning the reduction of risk of cardiovascular … [Read more...]
“Dear Doctor” Letter About Invokana And Amputations Was Sent In Canada
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...]
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...]