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What Are SGLT-2 Inhibitors?

Those who suffer from Type 2 diabetes have bodies that do not produce a sufficient amount of insulin. The lack of insulin means that blood glucose remains at high levels, building up in the bloodstream. Higher blood sugar levels have a variety of health effects, including kidney damage and heart disease.

Patients suffering from Type 2 diabetes need to find ways to counteract the effects of insufficient insulin. One way to achieve this is by administering an SGLT-2 inhibitor to keep the kidneys from reabsorbing glucose into the blood. If the drug works as intended, an SGLT-2 inhibitor can contribute to a lowering of blood sugar levels.

How SGLT-2 Inhibitors Work

Reabsorption of glucose into the kidneys requires certain facilitators and conditions to occur. One thing that aids in this absorption is SGLT-2. This is a protein that is found in the kidneys that acts as a transporter. It is responsible for nearly all of the glucose reabsorption. Thus, a medication that can act against the SGLT and its role in this process can help lower blood sugar.

The specific mechanism whereby an SGLT-2 inhibitor works is by targeting this protein. SGLT-2 inhibitors go after the transporter that brings the glucose into the blood. When that happens, glucose is not reabsorbed into the bloodstream. Instead, it exits the body through urine.

SGLT-2 Inhibitors Linked to Complications

A new class of drugs has been created that target the kidneys and help control blood glucose levels in patients with diabetes, but some patients are reporting harmful side effects.

Side Effects of SGLT-2 Inhibitors

  • Increased risk of amputation
  • Kidney damage
  • Diabetic ketoacidosis
  • Fournier Gangrene

SGLT-2 Inhibitor Medications & Manufacturers

  • Invokana (Janssen Pharmaceutical)
  • Farxiga (AstraZeneca)
  • Jardiance (Boehringer Ingelheim)
  • Glyxambi (Boehringer Ingelheim)
  • Synjardy (Boehringer Ingelheim)
  • Xigduo XR (AstraZeneca)

Who is Eligible to File a Lawsuit

Patients who took an SGLT-2 inhibitor prior to the FDA warning and suffered an injury may be eligible to file a lawsuit.

Lawsuits Against SGLT-2 Manufacturers

Patients who have experienced harmful side effects after taking an SGLT-2 Inhibitor can file claims against the makers of these drugs to compensate them for the injuries that they have suffered. Plaintiffs can receive payment for not only medical bills, but also for lost wages and pain and suffering. Given the severity of the negative effects of these medications, compensation for pain and suffering can be high.

Many of these lawsuits have yet to be filed. SGLT-2 inhibitors are still a relatively new class of drugs, having initially been approved by the FDA in 2013. This means that many patients may still experience side effects or are still within the statute of limitations that places time limitations on when they can file their suit. Many of the patients who have suffered harm after taking these drugs experience them shortly after beginning the drug regimen.

Even though some Invokana lawsuits have been settled by Johnson & Johnson, there are still hundreds of lawsuits relating to Invokana that are still outstanding in federal court. The plaintiffs are also filing cases against the manufacturer in state court. For example, there are many cases pending in Pennsylvania,  a jurisdiction where juries may make large awards to plaintiffs.

There have also been numerous cases against Boehringer Ingelheim and Eli Lilly for harm suffered by those taking Jardiance. Many of these cases are still being filed since the FDA did not issue any warnings about the medication until last year. These cases are still open and have not yet been settled or litigated. Much of the research and studies about Jardiance and Farxiga are still being released. This will likely be a growing area for lawsuits, especially as these medications are now taking market share from Invokana.

As of 2018, there were over 1,000 lawsuits filed against Janssen for Invokana injuries. The lawsuits were part of multi-district litigation in federal court in New Jersey, where the company is headquartered. At the time, Johnson & Johnson entered into a settlement agreement covering most of the lawsuits that were filed against it. While the amount of the settlement has not been released, it is likely that the damages were substantial, especially in light of other settlements involving Type 2 diabetes drugmakers that reached billions of dollars. The settlement established a fund to compensate those who were injured by the drug. It’s likely the companies will also settle the lawsuits pending in Pennsylvania and California state courts.

May 2015

The FDA issued a warning about SGLT2 inhibitors being linked to a potentially fatal condition called ketoacidosis.

September 2015

The FDA revised the warning label for Invokana to include the potential risks of bone fractures and decreased bone density.

December 2015

The first lawsuit was filed in Philadelphia, PA against Johnson & Johnson and Janssen Pharmaceuticals over their drug Invokana. Since then, other cases have been filed in Philadelphia, PA and in other courts.

August 2018

The FDA issued a warning about the risk of severe infections of the genitals with SGLT-2 inhibitors. The infection is commonly known as Fournier’s Gangrene.

October 2018

Johnson and Johnson and their subsidiary Janssen agreed to pay a settlement to resolve most of the 1,000 lawsuits filed against them in a New Jersey multidistrict litigation. The settlement amount was agreed to be confidential between the plaintiffs and defendants.

References

FDA. “FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”, U.S. Food & Drug Administration. Accessed May 30, 2019.

Mayo Clinic. “Canagliflozin (Oral Route)”, Mayo Clinic. Accessed May 30, 2019.

Mahakpreet Singh and Anoop Kumar. “Risks Associated with SGLT2 Inhibitors: An Overview.”, Curr Drug Saf. Accessed May 30, 2019.

MedicineNet. “What are SGLT2 inhibitors?”, MedicineNet. Accessed May 30, 2019.

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