In March 2013, the U.S. Food and Drug Administration (FDA) approved a new kind of medication to treat type 2 diabetes. Invokana debuted as the first in a new class of diabetes medications known as sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors).
Invokana works in a different way from older diabetes medications. The drug, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals division, blocks the reabsorption of glucose by the kidneys and increases glucose excretion, thereby lowering blood glucose levels.
Invokana brought hope to many of the 24 million Americans living with type 2 diabetes, but at what cost?
Risks Identified During the FDA Approval Process
Concerns about possible cardiovascular complications from Invokana were raised during the FDA approval process. The drug was approved by a vote of 10 to 5; however, future studies about cardiovascular safety were required. More specifically, the FDA required the following studies to be completed:
- A trial regarding cardiovascular outcomes.
- An enhanced pharmacovigilance program to monitor for things such as malignancies, pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes.
- A bone safety study.
- A pediatric pharmacokinetic and pharmacodynamic study.
- A pediatric safety and efficacy study.
Since the FDA’s approval of the drug, other concerns have also been raised.
Recent FDA Warnings About Invokana
In May 2015, the FDA warned that people who take Invokana may be at an increased risk of suffering from ketoacidosis, even though ketoacidosis is more commonly a threat to people with type 1 diabetes rather than people with type 2 diabetes. Ketoacidosis occurs when the body makes too many ketones, changing the patient’s metabolism. It is a serious medical condition that makes the blood too acidic and that can result in coma or death.
In September 2015, the FDA issued another Invokana safety announcement. This time the agency warned that the drug could result in an increased risk of bone fractures and a decrease in bone density.
Hundreds of adverse reactions have been reported by users of Invokana. If you have been hurt, or your loved one has been killed, then it is important to find out more about your legal rights and your possible recovery. Please start a live chat with us today to learn more about what you can do next.