In September, the United States Food & Drug Administration (“FDA”) strengthened its warning of adverse reactions–such as bone fractures–from Janssen Pharmaceuticals, Inc.’s blockbuster type 2 diabetes drugs Invokana and Invokamet (canaglifozin).
The initial adverse reactions for Invokana and Invokamet included the risk for bone fractures. However, following numerous clinical trials, the FDA thought it necessary to strengthen the warning of the bone fracture adverse reaction. The clinical trials noted that fractures of the upper extremities occurred as early as 12 weeks after starting Invokana & Invokamet. Those fractures arose from slight traumas such as knocking ones arm on a table.
The FDA required the manufacturer of Invokana and Invokamet to perform a separate clinical trial evaluating the bone mineral density of over 700 elderly individuals over a two year period. The trial showed that patients given Inovokana and Invokamet caused decreased bone mineral density in the hip and lower spine more so than those patients given a placebo.
What is Invokana?
Invokana® was the first SLGT2 inhibitor approved by the FDA. It is marketed as a cutting edge drug in the fight against Type 2 Diabetes. Invokana® is only approved to treat Type 2 Diabetes at this juncture. However, Invokana® was a highly criticized approval by the FDA, some going so far as to call Invokana® a “Questionable New Diabetes Drug.”
Not the First Warning Sign About Invokana and SLGT2 Inhibitors
The FDA released a safety warning in May, 2015 warning of the risk of diabetic ketoacidosis while on Invokana®, Farxiga®, Jardiance®, and the other SLGT2 Inhibitors. While not a recall of these drugs, the warning was significant in that it noted 20 instances of diabetic ketoacidosis, ketoacidosis, or ketosis over a one year period. All of these disorders are potentially deadly.
Cade Parian is an attorney who represents those injured by defective and dangerous drugs and medical devices. His office can be reached at (770) 727-5550 or by chatting live online at www.westgalawyer.com.