Soon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
FDA has approved canagliflozin/metformin (Invokamet, Janssen), the first fixed-dose combination in the class of sodium glucose co-transporter 2 (SGLT2) inhibitors for the treatment of adults with type 2 diabetes.
In adult patients with type 2 diabetes inadequately controlled on metformin monotherapy—the current standard of treatment— canagliflozin (Invokana) 100 mg and 300 mg reduced relative risk for myocardial infarction (1.6% and 3.0%) and congestive heart failure (2.7% and 4.0%), as compared to sitagliptin 100 mg, according to findings of the health economic simulation analysis presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco.
Type 2 diabetes mellitus presents multiple treatment dilemmas for prescribers and healthcare clinicians. The number of oral agents for treating diabetes has increased over the past decade, and the best treatment regimen for each patient often varies based on comorbid conditions and treatment goals. Hence, understanding the risks and benefits of each agent is vital. While the number of agents for treating type 2 diabetes mellitus continues to increase, prescribers and clinicians may struggle with the need to individualize care as a means to improve treatment outcomes.