Farxiga is a medication used to treat type 2 diabetes in conjunction with lifestyle changes like a healthier diet and exercise. Bristol-Myers Squibb and AstraZeneca teamed up to create Farxiga, which belongs to a newer class of drugs used to treat this type of diabetes. The U.S. Food and Drug Administration (FDA) approved Farxiga in 2014 after rejecting approval in 2011 on the grounds that there was not yet enough data and that there were some possible adverse events to explore further.
As a new drug, the long-term safety concerns are not fully understood, but most often Farxiga causes certain infections as a side effect. There is some evidence that there may be some more serious risks of taking the drug, including bladder cancer, adverse cardiovascular events, and diabetic ketoacidosis. The FDA is requiring more follow up studies to determine the long-term effects of using Farxiga.
What is Farxiga?
The generic name for Farxiga is dapagliflozin. It is a sodium-glucose transporter 2 (SGLT2) inhibitor and in a class of drugs called gliflozins. Approved by the FDA to treat type 2 diabetes, it is supposed to be used in conjunction with exercise and dietary changes to combat the disease. It is not indicated for the treatment of type 1 diabetes.
The first drug in this new class of medications for type 2 diabetes to be approved was Invokana, from Johnson & Johnson. It was first approved in 2013, so this entire class of drugs is new to the marketplace and new to researchers, doctors, and patients. Since the first one was approved, others have come along, including Farxiga, and the FDA has issued warnings as more research uncover some of the risks of using SGLT2 inhibitors.
How Farxiga Works
Farxiga and other drugs in its class work by inhibiting the reabsorption of glucose in the blood. Type 2 diabetes is a disease of glucose and insulin. Glucose is sugar and when levels of it in the blood get too high, it can cause serious complications. In a health person, the pancreas excretes the hormone insulin in response to high blood glucose levels. This controls glucose in the blood and keeps it at normal, healthy levels.
If you have type 2 diabetes, either your pancreas has stopped producing enough insulin or your body has become insensitive to insulin and your blood glucose levels no longer respond to it. Farxiga acts to lower blood glucose levels by inhibiting SGLT2. This prevents glucose from being reabsorbed into the blood from the kidneys. The result is that more glucose is excreted in the urine and blood glucose levels go down.
As more long-term research is conducted on Farxiga, more side effects and adverse events may be reported. For now, based only on the original clinical trials, the most common side effects are listed as certain infections. These include genital fungal infections and urinary tract infections. Other possible side effects are dizziness and light-headedness. Patients on Farxiga should be warned of the signs of infections and should report any to a doctor. These infections may require treatment.
The clinical trials for Farxiga showed some evidence that bladder cancer could be a potential side effect of use. In one of the trials, researchers saw an increase in the rate of this type of cancer, and so the label for Farxiga warns against using the medication in anyone with a history of bladder cancer, with current bladder cancer, or with kidney damage or disease.
Low Blood Pressure and Weight Loss
Other possible effects of Farxiga are weight loss and lower blood pressure. Both of these can be positive effects, but can also be harmful in certain people or if they are extreme. The medication lowers blood pressure by expelling fluids from the body as urine. Anyone with kidney damage, who is already taking diuretics, or who is elderly may experience a dangerous drop in blood pressure, called hypotension when taking Farxiga. Anyone at risk for hypotension should be evaluated before using the medication and should be monitored for signs of dangerously low blood pressure.
The FDA issued a warning in 2015 that any SGLT2 medication could cause a serious condition called diabetic ketoacidosis. This condition occurs as a complication of diabetes when the body can’t use glucose for energy. Instead it turns to fat and the breakdown of fat produces dangerous levels of chemicals called ketones. This acidifies the blood to a dangerous degree.
Anyone taking Farxiga should be aware of the signs of ketoacidosis and seek emergency medical treatment. Early signs include dry mouth, extreme thirst, and frequent urination. If left untreated, more symptoms will develop: fatigue, fruity breath, flushed skin, abdominal pain, nausea, and vomiting, confusion, and difficulty breathing.
Certain situations or conditions can increase the risk of experiencing ketoacidosis. These include not eating enough or not eating regularly. This can cause blood sugar levels to drop dangerously, especially while on a medication like Farxiga which actively lowers glucose levels in the blood. Ketoacidosis can be treated, but if left untreated, consequences can be serious, including a coma.
Farxiga, SGLT2s, and Lawsuits
Because the medications in the SGLT2 class are so new, all of the risks of taking them may not yet have been fully communicated. This means patients may suffer. Fortunately, the FDA has required that Bristol-Myers Squibb and AstraZeneca perform more clinical trials, even though the medication has been approved for use. One study ongoing is called DECLARE-TIMI 58 and involves over 17,000 patients who will be studied for between four and five years. The researchers are specifically looking for liver damage, cardiovascular risks, and cancer.
If you have taken Farxiga and you have experienced adverse events that have had lasting consequences for your health, you may have a case for a lawsuit. Some individuals have already filed lawsuits, claiming the manufacturers did not do enough to warn patients of some of the serious risks of the medication, like bladder cancer and infections. With the right representation on your side, you could make a case to get the compensation that will help you get your life back together after illness.