Invokana is a drug used to treat Type 2 diabetes, and is manufactured by Janssen, a subsidiary of Johnson & Johnson. Invokana was approved by the FDA on March 29, 2013 by a vote of 10-5. Some members of the panel had concerns regarding the potential risks of Invokana, particularly in light of another similar SGLT2 drug, Farxiga, which was initially denied FDA approval in 2012. Farxiga later gained approval in late 2013 by a vote of 13-1, with an overall agreement that the drug had an acceptable cardiovascular risk profile.
Issues related to incidences of breast and bladder cancer were the reasons associated with the initial denial of Farxiga. Unfortunately, since Invokana gained FDA approval, there have been some serious issues associated with the drug, including Invokana kidney disease, Invokana ketoacidosis and Invokana amputation. Those who were harmed by Invokana should consider speaking to an experienced Invokana injury lawyer.
Invokana—Wonder Drug or Dangerous Drug?
To many experts—as well as patients—the glucose-lowering drug Invokana was a welcome addition in the treatment of Type 2 diabetes—a disease which is increasing at an alarming rate among adults across the globe. Other experts felt there were simply too many unanswered safety questions to jump on the Invokana bandwagon. Many believed further study was necessary, and, in fact, Johnson & Johnson was ordered to conduct an additional five post-market clinical trials as part of their FDA approval for Invokana.
FDA Invokana Concerns
Even though the FDA panel approved Invokana, some members expressed concerns and emphasized the importance of the required post-market clinical trials. Erica H. Brittain, PhD, initially voted against approval of Farxiga at an earlier hearing, but voted for the drug in December. Brittain stated that “Even though my official vote has changed, my feeling hasn’t changed very much because not much has changed since then…It’s really critical that DECLARE get done. I’m voting contingent on the notion that it will be finished.”
The DECLARE placebo-controlled study followed more than 17,000 patients suffering from Type 2 diabetes, testing the efficacy of adding Farxiga to the patients’ current anti-diabetes treatment and the risks of cardiovascular events or death. The study is expected to provide necessary long-term safety information about SGLT2 drugs, however the results of the DECLARE study are not expected to be released until 2019.
The FDA required J & J and Janssen to add a Black Box warning regarding an increased incidence of amputations of the feet and legs, however there is no current recall of the drug in the works. Remember the incretin therapy diabetic drugs, Byetta, Victoza and Januvia which were also FDA approved, and believed to be safe, yet soon became the focus of mass litigation, due to an increased risk of pancreatic cancer. Many of those lawsuits claim the risks of pancreatic cancer and pancreatitis were well-known prior to the marketing of the drugs, yet patients were given the drugs with no warnings.
Other SGLT2 drugs, such as Farxiga, Glyxambi, Jardiance and Xigduo XR have also been named as causing injuries to patients, and Farxiga, like Invokana is the subject of a significant number of lawsuits. Invokana’s lawsuits include Invokana ketoacidosis lawsuits, Invokana kidney injury lawsuits and Invokana amputation lawsuits. A New Jersey woman claims she developed an acute kidney injury which led to end-stage renal disease less than two months after taking Invokana. A woman from Indiana claims the side effects of Invokana caused her to develop profound ketosis, after developing severe dehydration.
A Texas woman allegedly suffered kidney damage and ketoacidosis after taking Invokana for only a month, and a California woman allegedly developed acute kidney failure after taking Invokana. While the warnings on Invokana mention kidneys, they only state that a “possible” side effect could be kidney problems, which plaintiffs allege does not adequately convey the dangers of kidney failure. It could be extremely beneficial for those who have been harmed by Invokana to speak to an experienced Invokana injury lawyer. The attorneys at the law firm of Sullo & Sullo have extensive experience helping those injured by dangerous drugs and defective medical devices. If you believe Invokana caused your injuries, a call to the Invokana injury lawyers, Sullo & Sullo, can ensure your rights and your future are fully protected.