Do SGLT2 Inhibitors (Invokana, Jardiance, Farxiga) Cause Bladder Cancer or Breast Cancer?

Early trials for SLGT2 inhibitors, such as Invokana, Jardiance, and Farxiga demonstrated a possible increased risk of bladder and breast cancer. However, the drugs were still approved and do not display a prominent warning about the potential risk of bladder or breast cancer. Previous diabetic drugs such as Actos have been involved in massive lawsuits due to the failure to warn about the risk of bladder cancer. Now that SGLT2 inhibitors have been on the market for a few years, more studies are investigating the potential link between drugs like Invokana, Jardiance, and Farxiga with bladder and breast cancer. It is believed that the cancer risk associated with SGLT2 inhibitors is dose dependent. Therefore, the larger the dose and the longer a patient takes an SGLT2 inhibitor, the greater the risk of bladder or breast cancer.

Scientific Articles Linking SGLT2 Inhibitors to Bladder Cancer and Breast Cancer

September 2017: Bladder Cancer in the EMPA-REG OUTCOME Trial.

The study undertook an additional analysis of patients with at least 6 months’ drug expose to the SGLT2 inhibitors Invokana and Jardiance. 6 months’ cumulative exposure to an SGLT2 inhibitor demonstrated a doubling of the risk of bladder cancer. Rates of bladder cancer were noted to be higher in the Jardiance group when compared to the Invokana group.

October 2017: SGLT2 Inhibitors and Risk of Cancer in Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

The study aimed to evaluate the risk of cancer associated with SGLT2 inhibitors, such as Invokana, Farxiga, and Jardiance. The authors noted that the “association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and the risk of cancer in individuals with type 2 diabetes remains uncertain.” SGLT2 inhibitors did not show an increased risk of overall cancers, but they did show an increase for specific types of cancer, such as bladder cancer. Jardiance showed even higher levels of bladder cancer than Invokana.

November 2016: Benefits and Harms of Sodium-Glucose Co-Transporter 2 Inhibitors in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis.

SGLT2 inhibitors, such as Invokana were compared to a placebo. Over 6,000 patients in total were examined for the study. Six patients in the SGLT2-i arm were diagnosed with breast cancer, compared to only two diagnosis of breast cancer in the placebo arm.

June 2015: Glucuretic Effects and Renal Safety of Dapagliflozin in Patients with Type 2 Diabetes

The authors note that in clinical studies, the SGLT2 inhibitor Farxiga had a nearly six fold increase in the rates of bladder cancer when compared to a placebo. However, the FDA held that there were too few cases and insufficient data to determine causality. The author recommends that Farxiga “should not be used in patients with active bladder cancer and should be used with caution in those with a history of bladder cancer, taking into consideration the benefits of glycemic control versus unknown risks for cancer recurrence.”

Jan 2015: Successful  Integration of Nonclinical and Clinical Findings in Interpreting the Clinical Relevance of Rodent Neoplasia with a New Chemical Entity.

The author notes that while Invokana’s clinical studies did not demonstrate an association with bladder cancer in mice, in the 2-year rat study, increases in the rate of bladder cancer was observed. However, the study concludes that because there is a “lack of evidence for carbohydrate malabsorption or renal tubule injury in [humans] treated with [Invokana] in the clinical program, the tumor findings in the 2-year rat study were not deemed to have clinical relevance.”

Learn more about Invokana and SGLT2 inhibitors at our Invokana Lawsuit page.

Content Created By:

C. Brett Vaughn RN, BSN, JD