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When discussing the history of Invokana, one must first visit its origins before it was sold under this trademark label and was formerly known as canagliflozin. In May 2012, Janssen Pharmaceuticals Inc, a subsidiary of Johnson & Johnson, filed an application with the Food and Drug Administration seeking approval for this drug that was originally developed by Mitsubishi Tanabe Pharma Corporation in Japan.
Canagliflozin is an SGLT2 inhibitor, meaning that it inhibits reabsorption of glucose in the kidneys in order to lower blood sugar levels. However, this drug was reported to cause many intolerable adverse side-effects throughout its initial medical trials. Read on to learn more about the history of Invokana, as well as what options could be available to you if you wish to pursue litigation with the help of a skilled injury attorney.
In order to receive approval, Janssen had to prove to the FDA that it had conducted rigorous testing of the drug in order to show that it was effective at what the company claimed it could do. In addition, they were required to find and disclose any side effects or risks the drug could pose to patients who were taking it. To this end, the company conducted several clinical trials before the drug was approved.
One study found that patients with type-2 diabetes that had been unsuccessfully controlled by diet and exercise saw improvements in glycemic control and reduced body weight after taking canagliflozin. However, this study also found that about 60% of individuals receiving canagliflozin suffered some adverse event. Another study revealed similar results, where those patients taking canagliflozin experiencing improvements in glycemic control and reduced body weight, but with as many as 56% of the patients reporting some adverse event after taking the drug. A third study compared canagliflozin with sitagliptin, which involves a different class of inhibitors.
Doctors concluded that those taking canagliflozin experienced better glycemic control and had greater weight loss than those on sitagliptin. However, consistent with the results of the previous studies, 33% of the patients taking canagliflozin had to stop taking the drug, with many reporting intolerable adverse events as their reason for discontinuing the medication.
On March 29, 2013, the FDA approved canagliflozin and Janssen began to market the drug under the trade name Invokana. Shortly after they approved the drug, the FDA learned of other clinical trials which questioned Invokana’s safety, including the potential increased risk of lower limb amputations. After conducting its own investigations, the FDA issued a black box warning—its most serious warning available—for Invokana. Their investigations concluded that Invokana does pose a number of significant injury risks, including lower limb amputation and acute kidney injury.
If you or a loved one have been seriously injured due to side-effects experienced after taking Invokana, know that you may be entitled to compensation that can assist you in managing the medical expenses incurred as a result. While experiencing acute kidney injury or even a limb amputation can be an overwhelming situation, know that you do not need to face it alone. A professional dangerous drug attorney knowledgeable about the history of Invokana can help you hold the drug manufacturers accountable for the injuries you have suffered. If you have any inquiries regarding the history of Invokana and wish to bring about an injury case, reach out to a compassionate injury lawyer today to learn more.
Charles E. Boyk Law Offices, LLC