FDA Strengthens Invokana and Invokamet Warnings

FDA Strengthens Invokana and Invokamet Warnings | Pintas & Mullins Law Firm

The FDA recently added new warnings to the type 2 diabetes drugs Invokana and Invokamet, citing the increased risk of bone fractures. This comes only about six months after the FDA warned about a dangerous blood problem called diabetic ketoacidosis, which can be fatal. Our team of Invokana lawyers is currently accepting claims related to diabetic ketoacidosis and kidney damage from this drug.

The risk of bone density loss and fractures was already included on Invokana and Invokamet’s labels. After new clinical trials and reports from clinicians, the FDA decided to strengthen the warnings. The agency noted that fractures occur more frequently and earlier than previously believed. New data confirms that fractures can occur as early as 12 weeks into treatment.

Further, fractures often occur from minor incidents, like falling from standing height. Areas of the body most likely to break include the lower spine and hip.

This new data was from a clinical test the FDA required the drugs’ manufacturer, Janssen Pharmaceuticals, to conduct. The test analyzed changes in bone mineral density over two years of drug treatment in more than 700 elderly patients.

Diabetic Ketoacidosis

As stated, we are currently accepting clients who developed diabetic ketoacidosis from Invokana or Invokamet. This serious blood condition involves elevated levels of acids called ketones, which are released when the body burns fat instead of sugar for energy. The body prefers to use sugar for energy, however, drugs like Invokana and Invokamet cause the body to eliminate all sugars through urination. Once there is no more sugar left to use, the body must use fat, producing ketones.

Too many ketones in the blood eventually become toxic, leading to severe symptoms, hospitalization, months of recovery, and in some cases, death. Symptoms of this condition include excessive thirst, abdominal pain, weakness or fatigue, shortness of breath, confusion, and nausea or vomiting.

The Reality of Type 2 Diabetes Drugs

Type 2 diabetes is a serious disease affecting more than 29 million people in the United States. That is an enormous number, and very attractive to Big Pharma. There are dozens of diabetes medications on the market, and many patients assume these drugs are safe and will manage their conditions with minimal effort. Unfortunately, this is not the case. Type 2 diabetes medications can be extraordinarily dangerous and even fatal, and far too many patients underestimate the significance of lifestyle in managing and in some cases reversing their condition.

In a recent study, researchers looked at 30 type 2 diabetes drugs and found that none had rigorous proof of reducing heart attack, stroke, blindness or amputations. Further, these drugs were directly linked to at least 3,300 deaths and 20,000 hospitalizations since 2004.

Many doctors, more than you would think, are paid by Big Pharma to advocate for their drugs and change medical thresholds of diabetes and pre-diabetes so more patients can be prescribed their drugs. What these doctors may not tell you is that exercise, eating a plant-based diet, and cutting down on other unhealthy habits drastically reduces your risk and severity of type 2 diabetes. Even patients who do not see any marked improvement in fitness or weight loss show significant health benefits once they start exercising.

One exercise-training trial compared the effects of different types of exercise in patients with type 2 diabetes. Participants who were previously sedentary took part in aerobic training, combination training, or resistance training for nine months. Researchers found that the best exercise regimen was a combination of aerobic and resistance training. They also found that patients who did not see an improvement in their fitness did show marked improvements in blood sugar control and other important medical statistics.

The Invokana and Invokamet lawyers at Pintas & Mullins Law Firm offer free case reviews to concerned patients nationwide.