Following studies that found a risk of amputation with SGLT2 inhibitors including Jardiance and Farxiga, the manufacturers of these drugs are attempting to expand the FDA-approved uses for these medications.

While these medications are currently approved for the treatment and control of type-2 diabetes, the drug manufacturers are pushing for the medications to also be approved for the treatment of heart failure and kidney disease. Jardiance was previously approved in 2016 for reducing cardiovascular death. These medications may reduce the risk of developing heart disease, but that benefit may come at a serious cost.

Although type-2 diabetes treatment drugs such as SGLT2 inhibitors are popular with diabetics due to their positive side effects including weight loss and blood pressure improvement, these drugs may also cause a variety of serious side effects. For patients who have a history of peripheral artery disease, or who have previously suffered amputations, the risk of lower-limb amputation may be increased by SGLT2 inhibitors. While staying physically active and avoiding smoking cigarettes can help to reduce these risks, the drugs may still cause patients to experience negative side effects.

If the drugs are approved by the FDA for the treatment of these added conditions, thousands more Americans may be subject to the dangerous side effects associated with these drugs. As of April 2019, almost 40 lawsuits regarding Farxiga were pending in federal courts. Many of the plaintiffs in these lawsuits claim that the drug caused them to suffer complications serious enough to require foot or lower limb amputation.

Due to the serious risks including lower limb amputation associated with the SLGT2 class of diabetes drugs,  patients taking Farxiga may be wondering: is Farxiga safe?

Basics of Farxiga

Farxiga (also known by its generic name, dapagliflozin) is a type 2 diabetes drug used to lower blood sugar levels in patients. Farxiga was manufactured by AstraZeneca Pharmaceuticals and was approved by the U.S. Food and Drug Administration (FDA) in 2014.

Farxiga belongs to a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Other major SGLT2 inhibitors include Jardiance (empagliflozin) and Invokana and Invokamet (canagliflozin).

Farxiga Side Effects

While any medication will come with certain side effects, these risks must be acknowledged on the drug’s warning label so that patients and their doctors are able to properly weigh the risks and benefits of the drug.

In 2017, the FDA released a safety warning that two major clinical trials have linked the use of canagliflozin, a medication in the same class as Farxiga, with an increased risk of lower limb amputations of the toe, foot, knee, and leg.

According to recent research, SGLT2 inhibitors like Farxiga have been associated with an increased risk of lower limb amputation. Indeed, Scandinavian researchers reported that SGLT2 inhibitors placed patients at as much as twice the risk of lower limb amputation as patients taking other diabetes drugs. Previous clinical trials have associated canagliflozin, but not other SGLT2 inhibitors, with this increased risk.

In this new observational study, 61 percent of patients were on dapagliflozin (Farxiga), 38 percent on empagliflozin (Jardiance) and only 1 percent on canagliflozin (Invokana.) The study still found that patients taking these SGLT2 inhibitors faced approximately twice the risk of lower limb amputations as those taking other diabetes drugs.

In 2015, the FDA updated SGLT2 inhibitor labels to include the risk of diabetic ketoacidosis. In 2018, the FDA also warned about the risk of a flesh-eating infection of the genitals associated with SGLT2 inhibitors like Farxiga.

So, is Farxiga safe? The FDA has not yet issued an updated warning about Farxiga’s link with lower limb amputation, and researchers involved in this new study note that the relative risks of this drug should be weighed against its benefits and that the outcome may still be worth it.

Filing a Farxiga Lawsuit

More and more patients are coming forward with reports of major side effects after treatment with SGLT2 inhibitors like Farxiga. According to these lawsuits, drug manufacturers either knew or should have known about the risks associated with their SGLT2 inhibitors, including lower limb amputation.

However, lawsuits allege, these companies failed to adequately warn patients and the medical community about these risks, placing company profit over patient safety.

If you or someone you love has suffered from lower limb amputation or other serious side effects after taking Farxiga, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot undo the pain and suffering caused by major complications like amputation, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.