Ketoacidosis Problems Known on Johnson & Johnson’s Janssen Pharmaceuticals Drug Invokana

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A recent product liability lawsuit against Invokana manufacturer Johnson & Johnson’s Janssen Pharmaceuticals alleges the company knew of the risks associated with the drug, but minimized the information, misleading the public about the dug. Research has revealed the Invokana puts users at risk for diabetic ketoacidosis.

The complaint was filed in the US District Court for the District of New Jersey by Florida woman Laura Waddle. Waddle stated that after using Invokana for a few months she developed diabetic ketoacidosis after using Invokana for less than six months. The condition can result in hospitalization and the need for emergency treatment.

Diabetic ketoacidosis is a complication experienced by diabetics when their bodies are unable to produce enough insulin so high levels of blood acids develop. Insufficient insulin causes the body to break down fat to be used as fuel, which creates a buildup of acids in the bloodstream called ketones, eventually leading to diabetic ketoacidosis if untreated.

Invokana has been on the market since spring 2013. It was the first of a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors used to treat diabetes. Invokana became one of the most popular drugs available for treating type 2 diabetes, due in part to aggressive marketing efforts by Janssen. Throughout its three years on the market, the FDA has required several warnings be added to Invokana labels, as more risks become known.

The Waddle lawsuit is one of an increasing number of similar suits brought against Janssen regarding Invokana and ketoacidosis. Most of these allege Janssen knew of the risks associated with the drug, but continued to market it in the same way without providing warning to consumers or the medical industry.

According to Waddle’s complaint, the FDA has received many reports from Invokana users after they developed ketoacidosis. The FDA adverse event database shows Invokana users are several times more likely to develop the condition than those taking non-SGLT2 drugs for diabetes.

The FDA issued a safety communication in May 2015 warning Invokana users of the potential risk and ultimately required Johnson & Johnson to add a warning to Invokana labels telling users to stop taking the drug and seek immediate medical attention if they experienced any symptoms that could indicate acidosis, including fatigue, nausea, abdominal pain, vomiting, or respiratory problems. According to the warning, the FDA continues to investigate this safety issue and will determine whether changes are needed in the prescribing information for SGLT2 drugs in the future.

In addition to the numerous lawsuits alleging Janssen knew about the risk of acidosis but failed to warn patients, there have also been several complaints filed about Invokana’s link to kidney failure. These lawsuits allege a unique mechanism of action in the drug impacts kidney function and increases the risk for severe damage. In 2015, the Institute for Safe Medication Practices (ISMP) conducted a review of the FDA’s adverse event reports and determined Invokana and other drugs like it posed a potential risk for kidney damage.

Ongoing Research and Additional Warnings

In May 2016, the FDA issued an updated Invokana safety warning related to the drug’s potential to increase the need for foot, leg, and toe amputation, something that is already a risk for diabetics.

In addition to the amputation risk, the FDA also issued a warning concerning acute kidney damage for Invokana users, and the ISMP indicated a steady stream of new risks and warnings regarding Invokana highlight the need for additional testing for drugs before approval. More research is needed to determine whether or not Invokana and other SGLT2 drugs are worth the risks they pose to users.

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