Invokana, generic name canagliflozin, belongs to a newer class of drugs used to treat type 2 diabetes. Invokana was the first in the class of sodium glucose transporter 2 (SGLT2) inhibitors to be approved by the U.S. Food and Drug Administration. It is made by Johnson & Johnson and was approved in 2013. Since then more drugs under the same class have been developed by other companies and approved by the FDA for use in treating type 2 diabetes along with diet and exercise changes.
Because Invokana and other SGLT2 inhibitors are so new, not all of their safety concerns have been fully realized or proven. There is serious concern that this medication may increase the risk of having a cardiovascular event, bone fractures, and a serious and life-threatening condition called diabetic ketoacidosis. If you have taken Invokana and suffered from any of the side effects, you may be able to join one of the lawsuits that against the manufacturer.
What is Invokana?
Invokana is a medication used to treat type 2 diabetes. It belongs to the class of drugs called sodium glucose transporter 2 inhibitors and is indicated for treatment along with important lifestyle changes like eating a healthier diet, exercising more, and losing weight. Although it is not intended to aid weight loss, Invokana may help patients lose more weight if they are already taking steps to do so. Invokana may also be used in conjunction with other medications.
How Invokana Treats Type 2 Diabetes
Type 2 diabetes is a condition in which the body either produces less insulin than it needs or has become less sensitive to insulin. Insulin is a hormone that is produced and excreted by the pancreas in response to high levels of glucose, or sugar, in the blood. Chronically high blood sugar levels can cause serious complications over the long-term. These include heart disease, nerve damage, eye problems, kidney damage and stroke. Lifestyle changes and medications can help patients with this type of diabetes maintain healthy blood glucose levels.
Invokana works to regulate glucose in the blood by inhibiting or stopping SGLT2, a protein in the kidneys that is responsible for sending sugar back into the blood stream. Invokana blocks this protein, which in turn blocks the reabsorption of glucose into the blood. More glucose gets excreted through the urine instead. This helps lower blood sugar levels and also explains why the medication can help with weight loss as well.
Side Effects
The most common side effects of Invokana are increased and frequent urination, urinary tract infections, and yeast infections. The infections can be treated, so patients should report these to their doctors. Other side effects that are fairly common and which should go away as the body gets used to the medication include dry mouth, increased thirst, and constipation. Any side effects that do not go away should be reported.
Diabetic Ketoacidosis
One of the controversies surrounding this new medication is the possibility that it can cause a very serious and life-threatening condition called ketoacidosis. In 2015 the FDA announced that any SGLT2 inhibitor could cause the condition. It is a complication of diabetes and occurs when the body does not have enough glucose to consume for energy.
Without access to glucose, the body turns to fat to break down and get energy. The problem with this is that a byproduct called ketones builds up in the blood and makes it dangerously acidic. If you take any of these medications, look for the early signs of ketoacidosis and report them right away so you can be treated. These include extreme thirst, dry mouth, and frequent urination. As the condition progresses without being treated, you may experience flushed skin, abdominal cramping, nausea, vomiting, fatigue, confusion, an odor of fruit on your breath, and trouble breathing.
If you do take Invokana or another SGLT2, you can increase your risk of developing ketoacidosis by not eating enough or on a regular schedule. This, along with the medication, can make your glucose levels drop to dangerous levels and turn into ketoacidosis.
Bone Fractures
In 2015 the FDA also issued a warning about Invokana regarding bone fractures. The medicine already came with a warning that it could increase the risk of developing a fracture, but the FDA wanted to strengthen that warning. They found new information about how Invokana may decrease the mineral density of the bones, which in turn can weaken them and lead to fractures. Research into this issue is ongoing, but the FDA cautions that anyone using this drug be aware of the risk and of other factors that may lead to a bone fracture.
Heart and Kidney Problems
When the FDA approved Invokana it required that the company continue with post-market studies. One focus of the studies was to be the risk of adverse cardiovascular events while taking Invokana. There is little information yet, but there is some concern that this drug may increase the risk of fluid retention and edema, which can lead to congestive heart failure.
This is especially a risk for elderly patients, people taking diuretics, and anyone with kidney problems. The medication is contraindicated for anyone with severe kidney problems, as it may worsen them or increase the risk of fluid buildup. Invokana may also cause hypokalemia, a high level of potassium in the blood, which can cause heart arrhythmias.
Bladder Cancer
Although Invokana has not yet been implicated in any cases of bladder cancer, other SGLT2 inhibitors have. Because all of these drugs are so new, there could be many safety concerns that have yet to be discovered. If one of these medications increases the risks of bladder cancer, as seems to be the case with Farxiga and Xigduo, Invokana may come with this risk as well. These other SGLT2 inhibitors are not indicated for use in people with a history of bladder disease or cancer.
Lawsuits
If you have been taking Invokana and suffered from side effects without adequate warning about the risks, you may be able to make a case and start a lawsuit. Lawsuits already in place against Johnson & Johnson claim that the company did not warn patients or doctors about the risks, that they manufactured a defective drug, that they misrepresented the facts about risks and benefits, and that they were negligent in cases of ketoacidosis, heart failure, kidney damage, and other problems.
Sources
- https://www.nlm.nih.gov/medlineplus/druginfo/meds/a613033.html
- http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm
- https://www.invokanahcp.com/prescribing-information.pdf
- http://www.nytimes.com/2013/03/30/business/invokana-wins-fda-approval-for-diabetes-treatment.html
- http://www.mayoclinic.org/diseases-conditions/diabetic-ketoacidosis/basics/definition/con-20026470
- http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm