Updated September 14, 2017.

Following reports of acute pancreatitis among people taking a type of diabetes medication, the U.S. Food and Drug Administration (FDA) said it is “evaluating the need for regulatory action” over the SGLT2 inhibitor class of drugs.

SGLT2 inhibitors are approved to attempt to control blood sugar in people with type 2 diabetes, when used along with diet and exercise. They prevent the kidneys from recirculating excess sugar into the bloodstream, instead causing it to be expelled via urine. Weitz & Luxenberg is already pursuing legal action against the makers of SGLT2 inhibitors for the drugs’ link to other health complications.

The FDA’s latest notice was revealed in a list of potential drug risks and safety concerns raised from a quarterly review of reports to the agency’s Adverse Event Reporting System (FAERS) between April and June 2016.

The review lists drugs, potential safety signals, and agency responses in cases where the “FDA has identified a potential safety issue” but has not yet concluded that a drug is responsible for the risk.

Acute Pancreatitis: Symptoms and Treatment

Acute pancreatitis almost always requires hospitalization for treatment. Most cases resolve in one to two weeks, but complications may require several months for recovery.

Symptoms of acute pancreatitis may include:

  • Severe, sudden upper abdominal pain
  • Nausea and vomiting
  • Fever
  • Circulation problems
  • Bloated stomach

A case report published in 2015 drew attention to a link between canagliflozin (Invokana) and pancreatitis, calling it “a rare side effect,” but concluding it was a “potentially serious complication of canagliflozin” and a second case report warned that while rare, “physicians must be aware of this potentially fatal adverse effect.”

Other SGLT2 Inhibitor Health Complications

Previously, the FDA has issued safety communications about Invokana and other SGLT2 inhibitors being linked to diabetic ketoacidosis and serious urinary tract infections leading to blood or kidney infections. The agency has also recently required warnings for some SGLT2 inhibitors and a risk of acute kidney injury and amputation.

Consult your doctor before stopping any prescribed medication.

Lawsuits filed against Invokana’s maker claim the company knew about potential dangers but did not properly warn patients and doctors about the risks. More than 50 lawsuits over Invokana were combined into a multidistrict litigation (MDL) in New Jersey, in December 2016. There are now more than five hundred cases pending. Weitz & Luxenberg has also filed claims in the New Jersey Superior Court.

How Weitz & Luxenberg Can Help

Weitz & Luxenberg’s Drug & Medical Device Unit Practice Group Co-Chair Ellen Relkin says the firm is interested in hearing from people who have required hospitalization after taking Invokana or other SGLT2 inhibitors. The firm has several lawsuits already underway involving these drugs and a strong track record in handling complex medical lawsuits.

Ms. Relkin has been appointed to the Executive Committee of the Plaintiffs’ Steering Committee (PSC) in the In Re: Invokana (Canagliflozin) Products Liability Litigation pending in the U.S. District Court for the District of New Jersey (MDL 2750 Case Management Order #2).

The PSC is a committee of experienced attorneys responsible for working on strategic decision-making on behalf of all plaintiffs in the nationwide litigation. As a member of the Executive Committee, Ms. Relkin performs vital and exclusive functions, which include initiating and coordinating all pretrial discovery on behalf of plaintiffs in all actions which are coordinated with the MDL, and advocating on behalf of all plaintiffs.

Additionally, on July 13, 2017, Ms. Relkin was appointed by the Honorable Lorna G. Schofield as Co-Lead Counsel and Danielle Gold of Weitz & Luxenberg was appointed as Plaintiffs’ Liaison Counsel in the In Re: Farxiga (Dapagliflozin) Products Liability Litigation Multidistrict Litigation venued in the Southern District of New York.

Ms. Relkin was part of a team that won a $13.5 million verdict for a client in one of the early Vioxx trials, and was court-appointed lead counsel and played key roles in negotiating more than $5 billion worth of settlements for all plaintiffs in lawsuits involving faulty hip implants.

While a past record is no guarantee of future success, talking with an experienced attorney may help you explore your legal options. Call us at (877) 566-0055 or contact us using the form on this page for a free consultation.

  1. U.S. Food and Drug Administration. (2016, October 5). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) List from April to June 2016. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm523358.htm
  2. U.S. Food and Drug Administration. (2016, October 5). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) List from April to June 2016. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm523358.htm
  3. U.S. Food and Drug Administration. (2017, March 31). Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm
  4. U.S. National Library of Medicine. (n.d.). Acute Pancreatitis. Retrieved from https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022858/
  5. U.S. National Library of Medicine. (n.d.). Acute Pancreatitis. Retrieved from https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022858/
  6. Chowdhary, M., et al. (2015, June 26). Canagliflozin-induced Pancreatitis: A Rare Side Effect of a New Drug. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489815/
  7. Srivali, N., et al. (2015, June - August). Acute Pancreatitis in the Use of Canagliflozin: A Rare Side-Effect of the Novel Therapy for Type 2 Diabetes Mellitus. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513334/
  8. U.S. Food and Drug Administration. (2015, December 4). FDA Drug Safety Communication: FDA revises Labels of SGLT2 Inhibitors for Diabetes to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
  9. U.S. Food and Drug Administration. (2016, June 14). FDA Drug Safety Communication: FDA Strengthens Kidney Warnings for Diabetes Medicines Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR) Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm
  10. U.S. Food and Drug Administration. (2016, June 14). Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm
  11. U.S. Food and Drug Administration. (2016, August 2). Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) Between April – June, 2015. Retrieved from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm484292.htm
  12. United States Judicial Panel on Multidistrict Litigation. (2016, December 7). In re: Invokana (Canagliflozin) Products Liability Litigation. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2750-Initial_Transfer-12-16.pdf

Get the Help You Need Today

Free Case Review