Unlike traditional diabetes treatments — which use injected insulin to moderate blood sugar levels — Invokana allows excess blood sugar to be excreted through the patients urine. Clinical trials were run on more than 10,000 type 2 diabetes sufferers, and most showed improved blood sugar levels and blood pressure as well as no weight gain.
The gains didn’t come without some indications of side effects. There was some indication of elevated risk of stroke and heart attack within the first 30 days of beginning the medication. Patients also shows a rise in both good and bad cholesterol levels over the trial. However, the FDA is unsure about the significance of those findings and is not requiring a label on the drug warning about heart attacks and strokes. It is, however, requiring Johnson & Johnson to perform more studies on patients who have been taking Invokana to better assess that long-term risk.
“We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions,” said Dr. Mary Parks of the FDA.