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Invokana is a popular drug by Johnson & Johnson, which is part of a class of prescription medicines (SGLT2 inhibitors) that are FDA-approved, along with diet and exercise, to lower blood sugar in adults with type 2 diabetes. The drugs effectively reduce blood sugar by causing the kidneys to remove sugar from the body through the urine.
In March 2013, the U.S. Food and Drug Administration (FDA) approved Invokana use in treating type 2 diabetes. However, the FDA panel, voting 10-5 in favor of approval, had concerns over the drug’s safety and ordered long-term studies, due to concerns in part over an elevated risk of stroke and heart attacks.
Despite questions about its safety, Invokana was the first in this new class of diabetes drugs to receive FDA approval. These medicines are available as single-ingredient products and also in combination with other diabetes medications.
The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.
The US Food and Drug Administration (FDA) has warned that Invokana, as well as other SGLT2 Inhibitors – including Farxiga, Invokamet, Glyxambi, Xigduo XR and Jardiance – may lead to ketoacidosis, a serious health condition where the body produces high levels of blood acids called ketones, causing a severe accumulation of keto acids and decreasing PH of the blood. In more serious cases, ketoacidosis may require hospitalization – and can be fatal.
The FDA issued a safety announcement on May 15, 2105, advising patients using Invokana and other SGLT2 inhibitors to pay close attention for any signs of ketoacidosis and seek immediate medical attention if they experience possible Invokana side effects such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness.
Additionally, the FDA said health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.
“We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs,” the FDA said in its announcement.
Claims involving Invokana and other SGLT2 inhibitors are in the early stages. The Invokana claims allege that both the manufacturers and marketers of SGLT2 inhibitors, among them Johnson & Johnson, Janssen Pharmaceuticals Inc., AstraZeneca & Boehringer Ingelheim, did not properly warn patients and physicians of the many risks – including ketoacidosis – associated with Invokana and other drugs in this class.
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