Diabetes Meds Raise Risk Of Amputations. According to the European Medicines Agency (EMA), patients with diabetes who take Invokana, or other sodium-glucose cotransporter-2 (SGLT2) inhibitors may have an increased risk of lower limb amputations, especially the toes.
Diabetes medications cited include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empgliflozin). The EMA advised in a statement released in February, “Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful.”
Updated Diabetes Medication Warnings
In the European Union (EU), the warning on Invokana and other diabetes medications will be updated to include a potential increased risk of toe amputations. The European Commission asked the EMA to conduct a review of Invokana in April 2016. In July, the review was expanded to include other SGLT2 inhibitors. The review includes AstraZeneca’s Ebymect, Edistride, Xigduo and Foxiga, Janssen Pharmaceutical’s Invokana, and Vokanamet., Eli Lilly and Beohringer Ingelheim’s Jardiance, and Boehringer’s Synjardy.
“An increase in lower limb amputations has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines,” the EMA stated.
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In two clinical trials, CANVAS and CANVAS-R, studies, participants were patients at high risk of heart problems and involved comparing canigliflozin with a placebo. In this study, researchers found the rate of lower limb amputation to be 7 in 1,000 patient-years in patients taking 1000mg of Invokana daily and 5 in 1,000 patient-years in patients taking 300mg daily. Comparatively, the rate was 3 in 1,000 patient-years with a placebo. Patient-years means members of a population who have been affected by a certain condition (years of treatment with a given drug). There were approximately 4,300 patients enrolled in the study.
The CANVAS-R Study found the rate of lower limb amputation to be 8 in 1,000 patient-years with Invokana compared to 4 in 1,000 patient-years with a placebo, as of September 2016. There were more than 5,800 patients participating in the study.
The EMA noted, “The incidence of lower limb amputation given above for both CANVAS and CANVAS-R are based on interim data, and final incidence rates will depend on analysis of the final study datasets.” The studies are ongoing.
Invokana Ketoacidosis Lawsuits
Janssen Pharmaceuticals, a Johnson & Johnson (J&J) subsidiary, and Mitsubishi Tanabe are already involved in product liability lawsuits over Invokana. Plaintiffs allege that the Type 2 diabetes drug causes a condition called ketoacidosis, where the blood becomes too acidic. Plaintiffs allege that the companies neglected to sufficiently warn of the risks associated with the drugs.
Invokana ketoacidosis lawsuits have been consolidated into a federal multidistrict litigation (MDL) in New Jersey before U.S. District Judge Brian R. Martinotti. An MDL is frequently created by the U.S. Judicial Panel on Multidistrict Litigation (JPML) and is the consolidation of cases with similar complaints that are transferred to one court before one judge. This has the effect of streamlining the process, lessening court costs, resulting in a faster outcome, and is generally more efficient.
In the Invokana MDL, plaintiffs similarly allege that the medication caused ketoacidosis, kidney damage, and related injuries and that the drug companies failed to warn of the risks. At least 126 Invokana ketoacidosis lawsuits have been transferred since the MDL consolidation in December 2016.
FDA Warnings Concerning Invokana and other SGLT2 Inhibitors
In 2014, the U.S. Food and Drug Administration (FDA) approved Invokana. In patients with diabetes, the body is not able to properly break down sugar for energy. When sugar cannot be utilized, the body resorts instead to fat for energy. This results in the production of ketone bodies, which accumulate in the blood and makes the blood more acidic.
The FDA’s adverse event reporting database shows that patients taking Invokana are more likely to suffer from diabetic ketoacidosis (DKA) than are those taking non-SGLT2 diabetes drugs. Signs of ketoacidosis, according to the Mayo Clinic are, excessive thirst, frequent urination, nausea and vomiting, abdominal pain, shortness of breath, fruity-scented breath, and confusion.
In May 2015, the FDA updated the warning label on SGLT2 inhibitors to warn of ketoacidosis. The label update affected Farxiga, Jardiance, and three combination products that include an SGLT2 inhibitor with metformin: Invokamet, Xigduo XR and Glyxambi. Between March 2013 and June 2014, regulators reported 20 cases of ketoacidosis linked to an SGLT2 inhibitor. Hospitalization was necessary in all cases.
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