Jardiance is a medication used to treat type 2 diabetes. It acts to lower blood sugar and is prescribed to be used along with lifestyle changes like a healthier diet, getting more exercise, and losing weight. Jardiance was created and is now manufactured and marketed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Co. It was first approved by the U.S. Food and Drug Administration (FDA) for treatment of type 2 diabetes in 2011.
Although Jardiance has been proven effective at lowering blood sugar in certain patients and of reducing the risk of cardiovascular events in type 2 diabetes patients, this medication does not come without some serious risks. Like other drugs in its class, Jardiance has been linked to a serious condition called diabetic ketoacidosis. This can be life-threatening if not treated. This and other risks have been discovered after FDA approval, which means that the drug companies may have known about them and failed to adequately warn patients. If this is true, lawsuits may be successful against the drug makers and may help people recover monetary damages.
What is Jardiance?
Jardiance, generic name empagliflozin, is a drug approved by the FDA in 2011 to treat type 2 diabetes along with diet and exercise. It belongs to a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors. It is a newer class of drugs, which means that all the risks of taking these medications may not yet have been discovered. When the FDA approved Jardiance it required that the drug companies continue to conduct post-marketing studies to look at its safety in children and how it affects cardiovascular outcomes in all patients.
Jardiance is indicated to treat type 2 diabetes only. It is not indicated for type 1 diabetes, a condition in which a patient can no longer produce the hormone insulin and must inject it daily. In type 2 diabetes, patients may produce less insulin or become less sensitive to it. Without adequate insulin or good sensitivity to it, the result is dangerously high blood sugar levels. Over time this can lead to a number of serious complications like nerve damage, eye problems, blindness, kidney damage, and heart disease. Medications like Jardiance are designed to help people with type 2 diabetes maintain healthy blood sugar levels.
How it Works
As an SGLT2 inhibitor empagliflozin works by inhibiting this enzyme. SGLT2 is an enzyme in the kidneys that filters out glucose from the production of urine and sends it back into the bloodstream to be used for energy. This is fine in people with normal blood glucose levels, but in someone with type 2 diabetes it is better to excrete that excess glucose. By inhibiting SGLT2, Jardiance allows patients to excrete more glucose in the urine, which lowers blood sugar levels.
An often positive side effect of this action of Jardiance is that people taking it tend to lose weight. Because that excess sugar doesn’t go back into the blood stream, it is excreted and can’t contribute to extra weight gain. Losing weight is one way to combat type 2 diabetes. Although Jardiance is not supposed to be prescribed to aid weight loss, it has that effect for most people taking it.
The most common side effects of Jardiance are urinary tract infections and yeast infections. People taking the medication may also experience frequent urination, especially at night, and an increased thirst. This is because of the extra glucose being excreted in the urine. If you take Jardiance and experience symptoms of a yeast or urinary tract infection, report it to your doctor. These require additional treatment.
It is also possible to experience an allergic reaction to Jardiance, which may be severe and life-threatening. Signs of a reaction include mouth, throat, and face swelling, rashes, hives, and itchy skin, and trouble breathing and swallowing. These reactions can be life-threatening if not treated, so seek emergency medical attention if you see these signs.
Also possible with Jardiance is dehydration because of the increased urination. Patients are encouraged to drink more water to avoid this, but some will become dizzy or lightheaded because of taking the medication. Some patients may even faint. Additionally, the action in the kidneys means that in people with kidney damage or disease may suffer even more loss in kidney function or be more susceptible to dizziness and fainting.
Serious Urinary Tract Infections
Although urinary tract infections are listed as a common side effect of Jardiance, some believe that the warning is not emphasized enough. Some people may experience serious and debilitating infections that spread beyond the urinary tract and that require lengthy treatments to overcome. These infections may even be life-threatening.
The risk is serious enough that the FDA issued a special warning in 2015 regarding it. The warning stated that they had found 19 cases of blood infections that were life-threatening as well as very serious kidney infections in patients taking SGLT2 inhibitors like Jardiance. All of these cases started out as urinary tract infections and all people were hospitalized, some in intensive care. Along with the warning, the FDA required that the drug companies update their safety labels and continue post-marketing studies including investigations into infections for at least five years.
The FDA also issued a warning in 2015 that SGLT2 inhibitors like Jardiance could increase the risk of developing diabetic ketoacidosis, another life-threatening condition that requires treatment. Ketoacidosis occurs when the body does not have enough glucose to use for energy. To make up for this lack, the body starts digesting fat instead. As a result, a type of compound called a ketone builds up in the bloodstream, which causes the blood to become acidic. If left untreated, this can be fatal.
Early warning signs of ketoacidosis include thirst, dry mouth, frequent urination, and high measured blood sugar levels. Anyone taking Jardiance is urged to watch for these signs and to seek treatment if they are noticed. Later signs of ketoacidosis include nausea and vomiting, abdominal pain, fatigue, dry, flushed skin, confusion, a fruity odor on the breath, and difficulty breathing. Not eating enough can increase the risk for developing this serious condition.
Within one year, from 2013 to 2014, the FDA found 20 cases of reported ketoacidosis in its adverse events database. All cases seemed to be linked to SGLT2 inhibitors. The FDA issued a warning about the risk and urged patients and doctors to watch out for and to screen for signs of ketoacidosis. They have also required that the drug companies continue post-marketing studies investigating the condition in people taking Jardiance.
Lawsuits have been filed against drug companies that manufacture and market SGLT2 inhibitors, alleging that these companies knew about risks and did not communicate them adequately or knowingly marketed drugs that were known to be harmful. If you have suffered from serious infections or ketoacidosis from taking Jardiance, you could have a case against Boehringer Ingelheim and Eli Lilly. With a lawyer you could start a successful suit or join a class action suit to get the compensation you deserve.
- http://docs.boehringer-ingelheim.com/Prescribing Information/PIs/Jardiance/jardiance.pdf