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FDA Warning Increases Awareness of Potential Invokana Injuries

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On May 15, 2015, the Food and Drug Administration (FDA) released a drug safety communication warning doctors and patients about serious side effects associated with type 2 diabetes medication Invokana (canagliflozen), and other similar medications.

Since that warning, Invokana attorneys have been investigating potential Invokana lawsuits on behalf of victims and their families who have suffered injuries and financial damages as a result of Invokana injuries. These families can be overwhelmed with medical expenses and lost wages, all because Invokana manufacturers failed to provide adequate safety warnings on their products.

Manufacturers Overstate Benefits of Invokana

The FDA approved Invokana in March 2013 to help lower blood glucose levels in patients with type 2 diabetes. The drug belongs to a class of medications called “sodium-glucose co-transporter 2 (SGLT2) inhibitors,” which work by causing the kidneys to excrete some glucose through the urine.

Manufacturers Janssen Pharmaceuticals and parent company Johnson & Johnson advertised Invokana as an improved option over previous type 2 diabetes drugs, stating that it was not only effective at lowering blood sugar levels, but had also been found to help patients lose weight.

Consumer watchdog group Public Citizen sent a letter to the FDA urging them to take action against these types of ads in March 2015. In it, the group urged the administration to “halt the dissemination of direct-to-consumer advertisements for five prescription drugs approved only for the treatment of Type 2 diabetes,” of which Invokana was one of the five.

The group told the FDA that the ads were promoting the drugs for off-label uses like reducing blood pressure and encouraging weight loss. The drugs were approved only for lowering blood glucose levels, but the ads “clearly convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure.”

Patients Unaware of Invokana Link to Diabetic Ketoacidosis

Patients who ask their doctors about Invokana and other similar drugs may be doing so because of a hoped-for weight loss benefit, without being aware of other potentially serious side effects. In their May 2015 warning, for example, the FDA stated that it had received 20 reports of patients with type 2 diabetes who were taking SGLT2 inhibitors who were hospitalized for diabetic ketoacidosis (DKA), a serious condition that can lead to coma and death. These reports came in between March 2013 and June 2014, and the FDA stated they had continued to receive other similar reports since June 2014.

DKA can cause symptoms like nausea and vomiting, difficulty breathing, abdominal pain, confusion, and unusual fatigue. The FDA advised patients to be on the lookout for these types of symptoms, and to seek treatment immediately if they occur.

Does Invokana’s Benefits Outweigh Its Risks?

Invokana has also been linked to recurring urinary tract infections, kidney stones, kidney impairment, and kidney failure. Within just a year of being on the market, the drug was connected to 457 reports of problems sent to the FDA, raising questions about whether or not its benefits outweigh its risks.

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  1. Carrie Wornick says:
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    This is the first that we had started hearing about issues with ivonkana. My husbands last check up, they had noted that he had decreased renal function. I am concerned and want to get more info.