The first of what are anticipated to be many lawsuits filed over serious side effects from the diabetes drug Invokana was filed in December 2015 in Alabama. In that suit, the plaintiff contends she developed ketoacidosis -- a life-threatening condition where there is too much acid in the blood -- soon after taking Invokana. Another suit was filed in Pennsylvania with the same allegations against Janssen Pharmaceuticals, the maker of Invokana.
Both suits were filed shortly after the Food and Drug Administration (FDA) issued a Drug Safety Communication that added warnings to labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors, including Invokana, about the risks associated with the use of those drugs and the development of ketoacidosis and serious urinary tract infections.
In its communication, the FDA said it had also received reports of SGLT2 inhibitors linked to the development of life-threatening blood infections, kidney infections and kidney failure. The FDA also required manufacturers to conduct a postmarket study for five years on the effects of SGLT2 inhibitors and serious blood and kidney disease.
According to the FDA, symptoms of diabetic ketoacidosis include:
- Nausea and vomiting
- Stomach pain
- Unusual tiredness
- Deep, rapid breathing
- Dry skin and mouth
- Flushed face
- Frequent urination or thirst that lasts a day or more
- Fruity-smelling breath
- Muscle stiffness or aches
Besides Invokana, there are currently six other SGLT2 inhibitors on the market: Invokamet, Farxiga, Xigduo XR, Jardiance, Glyxambi and Synjardy. These drugs work to lower blood sugar in adults with Type 2 diabetes. According to the FDA, approximately 1.7 million prescriptions for SGLT2 inhibitors are written every year.
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