Farxiga belongs to a new round of drugs developed by multiple drug companies to combat the type 2 diabetes epidemic in the U.S. and elsewhere. Bristol-Myers Squibb and AstraZeneca teamed up to create the medication called Farxiga, generic name dapagliflozin. Like other similar new medications for diabetes, Farxiga is supposed to help patients manage high blood sugar along with exercise and eating a healthy diet.
The U.S. Food and Drug Administration (FDA) approved Farxiga in 2014, so this is a very new drug on the market. The manufacturers hoped to have it approved a few years earlier, but the FDA refused citing lack of evidence on adverse events. Now, safety concerns about Farxiga are coming to light, including the potential for bladder cancer and heart disease. The FDA is requiring more long term testing to look into these risks, but in the meantime Farxiga remains on the market and may become the target of numerous lawsuits in the near future.
What is Farxiga?
Farxiga, or dapagliflozin, belongs to a class of drugs called sodium glucose transporter 2 (SGLT2) inhibitors. The FDA approved Farxiga to be used along with diet and exercise to lower blood sugar levels in patients struggling with type 2 diabetes. This is a chronic condition characterized by blood sugar being too high most of the time. If not brought under control, these high levels can lead to very serious complications like heart disease, nerve damage, and eye damage, even blindness.
Farxiga is not the first SGLT2 inhibitor to hit the market. These medications, including Johnson & Johnson’s Invokana, the first to be approved, have soared in popularity in the few years they have been on the market. Type 2 diabetes has reached near epidemic proportions and drug companies have taken advantage by developing these drugs to combat high blood sugar. Unfortunately, some risks and complications have been discovered as well, and lawsuits are being filed.
A lot of patients tolerate Farxiga and other SGLT2 inhibitors, but there are some side effects that have to be weighed against the benefits of using them to control blood sugar. Most commonly patients experience infections, including urinary tract and genital fungal connections. With more time on the market, more side effects are being discovered and some of them have the potential to be serious and even deadly. Patients have started filing lawsuits over these for older SGLT2 inhibitors, and those for Farxiga are probably not far behind.
Although Farxiga has not yet been implicated in increasing the risk for adverse cardiovascular events, other SGLT2 inhibitors have. Invokana is one of those, and when it was first approved the FDA required that it be put through more testing for safety and cardiovascular outcomes.
The FDA reviewed some of the initial results and found that the risk for having a stroke increased by 46 percent for those taking the SGLT2 inhibitor compared to those taking a placebo. Further analysis of the data found that the risk may be even higher for all cardiovascular events as more results come in. If even more results come in like this from the study, it could be proven that the drug companies harmed patients with a defective and unsafe product.
In 2015 the FDA warned that Farxiga and other SGLT2 inhibitors have the potential to cause diabetic ketoacidosis. This is a serious and potentially fatal illness that occurs when the body cannot access glucose as an energy source. When this happens, the body starts to metabolize fat, a byproduct of which is a compound called a ketone. Too much ketone in the blood acidifies it and the acidification can reach dangerous levels if ketoacidosis is not treated.
The warning for ketoacidosis is serious, because if a patient does not recognize the signs and get medical treatment, the acidity of the blood can lead to a coma, and even death. Eating too little and letting blood sugar levels drop too low increases the risk of experiencing ketoacidosis. Patients who have suffered from this condition because of the drug may be able to file Farxiga lawsuits to seek compensation.
In clinical trials conducted by Bristol-Myers Squibb and Pfizer for testing the safety and effectiveness of Farxiga, a troubling complication arose. There was some evidence of a significant, although not common side effect of bladder cancer. The researchers saw that there was an increase in the rate of bladder cancers in this group as opposed to people not taking the medication.
The risk was found to be significant enough that the drug is contraindicated for anyone with bladder cancer, with a history of bladder cancer, or even with a history of kidney damage or disease. As studies continue, more information may come to light explaining the risk and proving that patients have been harmed by the drug and may have a right to file lawsuits against the drug companies.
SGLT2 and Farxiga Lawsuits
While there have been no Farxiga lawsuits to date, this medication is still new and has the potential to lead to real legal action. Patients who have suffered because of diabetic ketoacidosis, bladder cancer, or cardiovascular events may have a case to make against Bristol-Myers Squibb and Pfizer. They may claim in lawsuits that the companies marketed products known to have serious risks, failed to communicate the risks, or even that they produced and promoted defective products.
The makers of other, earlier SGLT2 inhibitors are already facing lawsuits. Some of these are over ketoacidosis. The FDA only required that drug makers carry a warning on their product labels in 2015, a few years after many had been approved. Patients who suffered ketoacidosis before the labeling requirement went into effect are filing lawsuits and claiming that they should have been warned. There have also been suits filed against companies for kidney damage. If you think you have a case for a Farxiga lawsuit, it is important that you speak to a lawyer so you can learn what your rights are, what your chances are for winning compensation, and what you need to do next.