Invokana recently received a Black Box warning from the FDA, the highest level of warning they issue. Reports revealed the type 2 diabetes drug is severely toxic and can cause life threatening complications. If you or a loved one took Invokana or Invokamet and developed Fournier’s Gangrene or had to have an amputation, contact AVA Law Group now. You may be entitled to a cash settlement for your Invokana injuries. Call our experienced Invokana injury attorneys today—time for recovery may be limited.
WHAT IS INVOKANA?
Invokana (canagliflozin) is a SGLT-2 inhibitor prescribed to treat Type 2 diabetes in adults. The popular diabetes medication blocks the re-absorption of glucose in the kidneys, which increases glucose excretion through the urine. This, then, lowers blood glucose levels and helps diabetes patients maintain their glucose levels. Invokamet, another SGLT-2 inhibitor, contains both canagliflozin and metformin and works similarly to Invokana to control blood sugar levels in individuals with type 2 diabetes.
Released in 2013, Invokana dominated the market as a quick success. Johnson & Johnson subsidiary Janssen Pharmaceuticals manufactures the blockbuster drug and generates over $1 billion in annual Invokana sales. Of the current SGLT-2 drugs on the market, Invokana is by far the most popular one in its class. Invokamet met similar success on the market after Janssen released it to the market after its FDA approval in 2014.
WHAT WENT WRONG?
The FDA recently discovered Invokana/Invokamet increased users’ risk of many serious side effects since its release and market approval. Some of these side effects are life threatening if left untreated.
In May 2019, The Institute for Safe Medication Practices (ISMP) released a QuarterWatch report stating that during its first year on the market, Invokana side effects were tied to over 450 serious adverse events reports submitted to the FDA that year. This could mean thousands of patients have continually suffered from Invokana problems since the drug’s release in 2013.
Reports claim the toxic medication caused patients to develop adverse side effects including flesh-eating Fournier’s Gangrene and lower leg amputations. If you were diagnosed with Fournier’s Gangrene or forced to have an amputation after taking Invokana, you could be a victim of toxic medication.
Researchers found Invokana users are twice as likely to undergo a lower limb amputation than those receiving a placebo. Unfortunately, that risk increases for patients who already suffered from a previous amputation.
In 2017, the FDA issued a safety warning about this new risk for Invokana users. They ordered for the prescription to carry a Black Box warning—the most serious label warning the FDA can issue—about the amputation risks. However, this warning came too late for many Type 2 diabetes patients.
One 2017 study indicated that Invokana use increased leg and foot amputation risk by a massive 97%. Researchers say the amputation risk could be due to the medication decreasing blood flow to the lower limbs. The decrease in blood flow then exposes legs, feet, and toes to high infection risks.
Symptoms/Conditions Preceding Lower Limb Amputation:
- New pain, sores, ulcers, or infections in legs or feet
- Previously undergoing an amputation.
Fournier’s gangrene (necrotizing fasciitis) is a severe flesh-eating bacterial infection. The infection impacts nerves, fat, muscles, and blood vessels around the genitals and can be life threatening if left untreated.
Fournier's gangrene typically affects men, but women are also susceptible to the disease. As a degenerating disease, Fournier’s gangrene worsens over time, which means victims often need surgical procedures. But, if caught in the early stages, Fournier's Gangrene can be treated with antibiotics and not surgery.
In August 2018 the FDA ordered for new boxed warning labels for Invokana after cases of Fournier’s Gangrene arose in patients taking similar medications. Boxed warning labels are the most severe warnings the FDA can issue for a drug. But, the alert came too late for many Invokana users. Since 2013, 12 patients prescribed SGLT-2 inhibitors like Invokana developed Fournier's gangrene in the genital region with one of them dying from the disease.
In May 2019, researchers confirmed the serious risk of Fournier’s gangrene in Invokana users, saying onset for the disease ranged from a few days to over four years. So, many individuals could still be susceptible to Fournier's Gangrene even if they are currently not experiencing any symptoms.
Symptoms of Fournier's Gangrene:
- Tenderness and/or pain in the genital area
- Redness in the genital area
INVOKANA INJURY LAWSUITS
If you or a loved one used Invokana or Invokamet and were diagnosed with Fournier’s gangrene or needed a lower limb amputation, you may be entitled to legal compensation through filing a product liability claim.
Thousands of patients across the US are filing claims against Johnson & Johnson’s Janssen Pharmaceuticals for causing their severe injuries. Plaintiffs claim Janseen failed to warn patients and medical providers about the medication's serious side effects since it was first introduced in 2013. Many lawsuits even claim that the company withheld the dangers of Invokana from the FDA and knowingly sold dangerous medication to patients. Some suggest the severe side effects imply thorough research was not conducted before the drug was released to the public, which put thousands of Americans at risk.
CONNECT WITH OUR INVOKANA INJURY LAWYERS TODAY
When your health and livelihood is on the line, AVA Law Group’s here to make sure your rights are protected and fought for. Connect with one of our experienced injury attorneys today and see if you qualify for compensation for your injuries.
We provide easy access to some of the best personal injury lawyers in the country with proven track records of success for clients. We take care of the legal hassle so you can focus on healing and getting back to where you were before you were injured. Contact AVA Law Group today for your free, no obligation case evaluation and start taking steps towards justice.