The Blackwell Law Firm is investigating claims of personal injury related to the drug Invokana. Invokana (canagliflozin) is a relatively new drug sold to treat Type 2 diabetes. The drug represents a new class of medications known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other drugs in this class include Farxiga, Jardiance, Glyxambi, and Xigduo XR. These drugs work by altering kidney function to stop reabsorption of glucose into the blood stream.
The Food and Drug Administration (FDA) approved Invokana in March 2013. Since approval, Invokana sales have grown rapidly. Drug maker Johnson & Johnson has earned blockbuster profits from Invokana and, later, the related drug Invokamet.Invokana and Diabetic Ketoacidosis
Once on the market, Invokana was soon linked to a large number of adverse event reports. These included reports of kidney damage, kidney failure, urinary tract infections and ketoacidosis. In May 2015, the FDA issued a drug safety communication warning patients about the risk of ketoacidosis from Invokana and other drugs in the same class.
Diabetic ketoacidosis is a build-up of acid in the blood. It is a serious condition and can result in a diabetic coma or even death. Some symptoms of ketoacidosis include:
- Abdominal Pain
- Difficulty Breathing
- Vomiting / Nausea
- Unusual Fatigue / Sleepiness
We began investigating Invokana because of its association with diabetic ketoacidosis. While problems with diabetic ketoacidosis quickly emerged, this is not the only injury associated with Invokana.Invokana and Kidney Damage
On June 14, 2016, the FDA issued a new safety announcement about Invokana and the other drugs in its class. Now, the manufacturers of Invokana, Invokamet, Farxiga and Xigduo XR were required to add stronger labels warning about the risk of kidney damage. The introductory paragraph of the June 2016 FDA communication states:
The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR). Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
The risk of kidney injury was not a new concern. From its market inception in March 2013 through 2015, numerous FDA adverse event reports potentially linked these drugs to kidney injury and failure. Moreover, in May 2015, the Institute for Safe Medication Practices (ISMP) published an article discussing the issue and asking whether the potential risks outweighed the benefits.
Many potential injuries are not reported to the FDA. The problems are often much worse than indicated in adverse event reports. In addition to requiring new warnings of potential kidney injury, the FDA has urged doctors to pay attention to factors which may increase the risk of kidney injury in these patients.Invokana Lawsuits
Over the last couple years, a growing number of lawsuits allege severe injury from Invokana and the other drugs in its class. Lawsuits alleging injuries including ketoacidosis and kidney damage have been filed in numerous courts.
Yet, these are not the only problems linked to Invokana. In September 2015, the FDA mandated a warning related to the link between Invokana and decreased bone density as well as fractures. In May 2016, the FDA issued a safety communication about Invokana and a potential link to foot/leg amputations.
Diabetes is a serious health condition in the United States. Yet, many new medications raise serious questions. We are closely following legal and medical developments related to Invokana. We are investigating potential claims on behalf of Alabama patients who suffered injury while prescribed these medications. If you or a loved one has taken Invokana and suffered serious injury, please contact the Blackwell Law Firm. We would be happy to discuss your potential claim or provide additional information. We also encourage you to read our blog posts discussing these drugs.