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 once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo, AstraZeneca) (XR) for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
Four-year data from a phase 3 study examined the durability of glycemic response with dapagliflozin as add-on therapy to metformin vs. glipizide in patients with type 2 diabetes inadequately controlled with metformin alone. The data was presented at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna, Austria.
Antidiabetic drugs are considered to be first-line treatment options for individuals with type 1 and type 2 diabetes mellitus. It is estimated that type 2 diabetes affects about 24 million persons in the United States. Over time high blood levels can lead to complications such as heart disease, kidney damage, or blindness.1 When it comes to the treatment of type 2 diabetes individuals have the option of using oral hypoglycemic agents, compared to individuals with type 1 diabetes that requires insulin therapy.
FDA has approved dapagliflozin tablets (Farxiga, Bristol-Myers Squibb and AstraZeneca) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. This marks a rebound for the drug, which FDA rejected last year, citing concerns raised by studies linking the drug to bladder cancer and liver toxicity.
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.