Brand Names: Invokana, Invokamet
Generic Names: Canagliflozen, Canagliflozen and Metformin
Invokana is a new drug that recently gained approval by the FDA, in March of 2013, to improve glycemic control in adults with type 2 diabetes. If you have experienced injuries from taking Invokana, contact us today.
Function: Invokana is a new drug that recently gained approval by the FDA, in March of 2013, to improve glycemic control in adults with type 2 diabetes. In order to improve glycemic control, Invokana acts by interfering with transport and absorption of glucose (blood sugar) and sodium in the human blood supply. The inhibition of these critical mechanisms, results in the excretion of sugar through the kidneys instead of being readily metabolized.
Side Effects
Invokana can result in many side effects such as:
- Dehydration
- Urinary Tract Infections
- Kidney Issues
- Hyperkalemia (high amount of potassium in your blood)
- Hypoglycemia (low blood sugar)
- Serious allergic reaction
- Headache
FDA Warning
On May 15, 2015, the FDA issued a warning that type 2 diabetes medications may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones, which may require hospitalization.
Canagliflozen, the active ingredient in Invokana, was directly named in the FDA’s health advisement warning.
The warning did not recommend those taking Invokana to cease or change their diabetes medication without speaking to their healthcare provider, but it did recommend that healthcare providers discontinue the medication if ketoacidosis is confirmed.
If left untreated, ketoacidosis could result in organ failure and death.
Studies Reported
The FDA’s 2015 warning regarding type 2 diabetes medication was supported by an unusually high incidence of adverse events, reported by the FDA’s adverse event reporting system.
The database reported 20 cases of diabetic ketoacidosis in patients treated with this class of medication from March 2013 to June 2014. Since this time, the database has continued to receive additional reports of diabetic ketoacidosis in patients treated with SGLT2 inhibitors. The FDA has urged health care professionals to continue to report side effects involving SGLT2 inhibitors to the FDA MedWatch program.
Aside from the studies regarding the FDA’s 2015 health advisory warning, the FDA is also requiring five post marketing studies for Invokana: a cardiovascular outcomes trial; a pregnancy outcomes trial; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA).
Your Legal Options
If you were prescribed Invokana during the period it was on the market, you may be dealing with very serious physical health problems or a permanent condition that has greatly reduced your quality of life and general health.
If so, connect with our firm immediately so we can begin the process of seeking compensation for you. A full review of your situation is the first order of business and should occur without delay. Call Gruber Law for immediate assistance.
Sources:
- FDA: Invokana FDA Approval
- FDA: Invokana Medication Guide
- FDA: Invokana Health Advisory Warning
