Update: Farxiga Litigation Centralized in New York
April 13, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits involving Farxiga and Xigduo XR be centralized for pretrial handling in the Southern District of New York. JPML agreed that the actions share factual questions arising from the allegations, thus implicating numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of Farxiga and Xigduo XR.
What’s the Problem?
The new type 2 diabetes medication Farxiga (generic: dapagliflozin) has recently been linked to serious side effects including diabetic ketoacidosis (DKA), acute kidney injury and urinary tract infections (UTIs).
What is Farxiga?
Farxiga is a sodium-glucose co-transporter-2 (SGLT2) inhibitor drug that helps control blood sugar levels in patients with type 2 diabetes. AstraZeneca, the company that makes Farxiga, originally applied for approval of the drug from the U.S. Food & Drug Administration (FDA) in 2012; however, the application was initially rejected over concerns about the medication’s potential effect on the liver. The second SGLT2 inhibitor, Invokana (generic: canagliflozin), was approved by the FDA in March 2013, and after additional studies, Farxiga was finally approved in January 2014.
Farxiga Side Effects
Serious side effects of Farxiga may include:
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Amputations of the foot, leg or toes
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Infections (Pyelonephritis)
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Bladder Cancer
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
- And more
The FDA on May 15, 2015, issued a Drug Safety Communication warning that SGLT2 inhibitor diabetes drugs had been linked to at least 20 reports of potentially fatal diabetic ketoacidosis. All cases required hospitalization or an emergency room visit to treat. As a result of these problems, the agency announced on December 4, 2015, that SGLT2 inhibitor labels would be changed to include a warning about ketoacidosis and serious urinary tract infections (UTIs).
The Institute for Safe Medication Practices (ISMP) on January 13, 2016, issued a QuarterWatch Report detailing injuries associated with SGLT2 inhibitors. The agency found that by the second half of 2015, at least 411,000 Farxiga prescriptions had been filled in the U.S., and 80 adverse events had been linked to the drug.
On February 25, 2016, the European Medicines Agency (EMA) reported on the occurrence of at least 100 cases of DKA in patients treated with SGLT2 inhibitors in Europe. “Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports, blood sugar levels were only moderately increased,” the agency said. “These uncharacteristic blood levels could delay diagnosis and treatment.”
Diabetic ketoacidosis is a serious complication of diabetes resulting from low insulin levels, which causes symptoms including:
- Rapid weight loss
- Nausea or vomiting
- Stomach pain
- Excessive thirst
- Fast and deep breathing
- Unusual sleepiness or tiredness
- Sweet smell to the breath
- Sweet or metallic taste in the mouth
- Different odour to urine or sweat
SGLT2 inhibitor labels were updated on June 14, 2016, to include information about the risk of acute kidney injury. From March 2013 to October 2015, at least 101 confirmable cases of the condition had been reported to the FDA in patients treated with the drugs. The agency cautioned that this number only includes submitted reports, and that there are likely additional cases of acute kidney injury associated with SGLT2 inhibitors of which it is unaware.
Farxiga was linked to at least 10 cases of bladder cancer during clinical trials. FDA has asked the manufacturer to warn physicians against prescribing Farxiga to high-risk patients, monitor rates of bladder cancer, and include warnings about this potential side effect on the product’s labeling.
2012 – Application for approval submitted and rejected
2012 – AstraZeneca submits application for approval of Farxiga to the U.S. Food & Drug Administration (FDA). The application is rejected over concerns about the drug’s effect on the liver.
2014 – Approved by the FDA
January 8, 2014 – Farxiga approved by the FDA to treat type 2 diabetes.
2015 – FDA Drug Safety Communication issued
May 5, 2015 – FDA Drug Safety Communication issued over increased risk of diabetic ketoacidosis with SGLT2 inhibitor diabetes drugs.
2015 – SGLT2 inhibitor labels updated
December 4, 2015 – SGLT2 inhibitor labels updated to include warning about ketoacidosis and urinary tract infections (UTIs).
2016 – Institute for Safe Medication Practices report issued
January 13, 2016 – The Institute for Safe Medication Practices (ISMP) issues its QuarterWatch report, finding that at least 80 adverse events had been linked to Farxiga during the second half of 2015 alone.
2016 – European Medicines Agency warning
February 25, 2016 – The European Medicines Agency (EMA) warns of at least 100 cases of diabetic ketoacidosis in patients treated with SGLT2 inhibitors.
2016 – Farxiga label updated
June 14, 2016 – Farxiga label updated to include acute kidney injury warning.
- “FDA NEWS RELEASE: FDA approves Farxiga to treat type 2 diabetes”. U.S. Food & Drug Administration (FDA). January 8, 2014.
- “FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood”. U.S. Food & Drug Administration (FDA). May 15, 2015.
- “SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections”. U.S. Food & Drug Administration (FDA). December 4, 2015.
- “QuarterWatch: Monitoring FDA MedWatch Reports”. Institute for Safe Medication Practices (ISMP). January 13, 2016.
- “EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes”. European Medicines Agency (EMA). February 25, 2016.
- “Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication – Strengthened Kidney Warnings”. U.S. Food & Drug Administration (FDA). June 14, 2016.
- “FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)”. U.S. Food & Drug Administration (FDA). June 14, 2016.