In May 2015, the Food and Drug Administration (FDA) issued a warning about diabetes treatments that used canagliflozin, dapagliflozin, and empagliflozin, including Invokana and Invokamet. The FDA reported that these drugs may cause a condition called ketoacidosis. This condition occurs when the body produces high levels of blood acids called ketones. Too many ketones in the blood stream could require hospitalization and could ultimately lead to death in rare cases.
Invokana was developed by Johnson & Johnson as a treatment for Type 2 diabetes. It is an oral medication that is generally only used when diabetes cannot be controlled through other means, like diet and exercise. It is not used to treat those with Type 1 diabetes or other related problems.
It triggers the kidneys to release excess blood glucose through the urine, decreasing blood sugar. This is an alteration of the normal function and processes of the kidney. This specific type of diabetes treatment is known as SGLT2 (sodium-glucose co-transporter 2) inhibitors. As of 2013, they are only FDA approved for use in those with Type 2 diabetes.
Other similar medications include:
- Xigduo XR
The FDA is continuing to evaluate the situation.
Invokana and Ketoacidosis
The most serious side effect of Invokana or Invokamet is ketoacidosis. This condition occurs when there is too much acid in the blood. Signs of this condition according to the FDA include:
- Difficulty breathing
- Unusual fatigue or sleepiness
- Abdominal pain
Symptoms can develop in as little as two weeks after taking the medication. Once the blood has become too acidic, it can take a very short amount of time for symptoms to appear—usually within 24 hours. Those over age 75 are more likely to experience these side effects.
If you have these symptoms, speak with your doctor as soon as possible. However, the FDA warns that you should not discontinue taking any prescribed medication until speaking with a medical professional.
The European Medicines Agency (EMA) has also begun to review Invokana and similar medications. This review was specifically requested by the European Commission after reports of diabetic ketoacidosis. All 101 worldwide reports as of May 19, 2015 were serious and required hospitalization.
They noted that although “normal” diabetic ketoacidosis is usually associated with high blood sugar levels, these cases did not involve higher-than-normal levels. This can make the condition more difficult to diagnosis.
Other Invokana Side Effects
In addition to ketoacidosis, Invokana and Invokamet have also been associated with other serious side effects. According to a study conducted by the Institute for Safe Medication Practices, there were 457 serious adverse reports within the first year that Invokana was released. These included:
- 54 instances of kidney failure or impairment
- 54 cases of dehydration and fluid imbalance
- 11 instances of kidney stones
- 50 cases of urinary tract infection
- 52 cases of abnormal or other weight loss
They also identified 50 cases that involved two types of hypersensitivity. These either involved a rapid swelling of the tongue, lips, face, or throat, or skin rashes and welts. Fungal infections were also relatively high.
Testing on animals showed that long-term use could result in kidney damage, kidney and testicular cancer, and bone abnormalities. It does not appear that Invokana has been tested for its long-term adverse effects in humans at this point, however.
Invokana lawsuits are beginning to appear throughout the country. They are alleging that the companies marketing and selling Invokana and similar medications have:
- Not adequately informed the public about the dangerous side effects of the medication
- Improperly marketed the medication
- Concealed knowledge about the risks in order to avoid decreased sales
- Created or manufactured a dangerous or defective drug
- Known or should have known about the potential serious side effects
A consumer group called Public Citizen also objected to the drugs’ FDA approval in 2013. They argued that the drug had not yet undergone enough testing to be considered safe for use.
The FDA specifically stated that its usual testing process may not be sufficient to fully test the potential adverse effects of Invokana. Instead, it allowed manufacturers to sell the drug with explicit instructions to keep a close watch on negative side effects. The FDA requested a final report in 2023—ten years after the drug was approved for sale.
A doctor for Public Citizen unambiguously cited the increased risk for many of the negative side effects that have appeared following use. Public Citizen placed Invokana and similar drugs on their personal “Do Not Use” list.
Public Citizen also argued that the drug was inappropriately being labeled as a way to help those with diabetes reduce their weight as well. They argued that the FDA had not approved them for weight loss and the company was leading the public to believe that the drug was safe for this use through its misleading labeling practices. They had similar complaints about the drugs’ use for reducing blood pressure.
How to Hire an Invokana Lawyer
Speak to a medical professional immediately if you start seeing signs of the serious negative side effects of Invokana and related medications. Quick action may prevent kidney failure or ketoacidosis.
If you or a loved one has been injured after using Invokana or a similar drug, then you may be entitled to compensation. An Invokana lawsuit could help you pay for medical bills, pain and suffering, lost wages, and any other harm that this drug imposed on you and your family.
The Invokana investigation is still ongoing. Another benefit of an Invokana lawsuit is that sharing your story with the millions of other people who take this drug can save lives. Your stories of harms can force the manufacturer to warn of negative side effects or force them to alter the drug so it is safer for the public. Responsible companies will immediately recall the drug completely until further testing can be carried out, but this is rarely done unless they are forced. You can help.
Call The Dixon Injury Firm at 855-55-BAD-DRUG (855-552-2337). We will provide a free consultation to discuss your unique situation. Don’t face these negative side effects alone. Call today.