Several drugs that are part of a new class of diabetes drugs, the Sodium-glucose co-transporter 2 (SGLT2) inhibitors, were approved by the U.S. Food and Drug Administration (FDA) despite the fact that they have some disturbing side effects. These medications include Invokana, Invokamet, Farxiga, and Jardiance.
Clinical trials of more than 10,000 patients showed that while Invokana improved patients’ blood-sugar levels and led to weight loss and reductions in blood pressure, patients also showed signs of elevated stroke risk and a small increase in heart attacks experienced within 30 days of taking the medication. Invokana was also shown to raise LDL, or “bad” cholesterol levels, although it also improved the levels of HDL, known as “good” cholesterol.
The FDA called the significance of these findings unclear, and the label of the drug is not required to carry any warnings about heart attacks or strokes. However, J&J is being required to closely monitor patients enrolled in long-term safety studies.
Some members of the FDA advisory panel that voted 10-5 to approve Invokana stated that they did not think the drug should be prescribed to patients with moderate kidney disease because it was not found to be as effective for those patients and they were at a higher risk for negative side effects compared with those with normal kidney function.
SGLT2 Inhibitors Linked to Ketoacidosis
In a warning issued on May 15, 2015, the FDA stated that it had received a significant number of reports linking the SGLT2 inhibitors to ketoacidosis, a very serious and potentially fatal condition in which the acid level in the blood rises dangerously high. Symptoms of ketoacidosis include:
- Difficulty breathing
- Abdominal pain
- Unusual fatigue or sleepiness
Although ketoacidosis typically only occurs in patients with type 1 diabetes who have blood sugars above 300 mg/dl, type 2 diabetes patients who were exposed to SGLT2 inhibitors developed ketoacidosis with only modestly elevated blood sugars. Experts theorize that these medications might promote ketoacidosis because they make it harder for the body to eliminate ketones as they build up.
There are a growing number of individuals discussing Invokana lawsuits that allege that the drug maker failed to adequately warn consumers and the medical community about the potential risk of ketoacidosis with Invokana usage.