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A prominent consumer watchdog group wants federal regulators to add even stronger warnings about the side effects of Invokana, Farxiga, Jardiance and similar diabetes drugs, which have been linked to a risk of serious and potentially life-threatening cases of diabetic ketoacidosis.
In a petition (PDF) filed with the FDA on June 24, Public Citizen calls for the agency to require the manufacturers of all sodium-glucose cotransporter-2 (SGLT-2) inhibitors to add a boxed warning, which would contraindicate use of the new-generation drug by Type 1 diabetics.
The group indicates that the warning should indicate Type 1 diabetics may face life-threatening risks from diabetic ketoacidosis associated with the medications. If added, the boxed warning would be the strongest label information the FDA can require a drug maker to place on approved medications.
Diabetic ketoacidosis (DKA) occurs when high levels of blood acids, known as ketones, build up in the body. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring hospitalization, urgent medical treatment, and potentially resulting in severe health consequences.
Although diabetic ketoacidosis is commonly associated with Yype 1 diabetes, it is not normally seen among patients diagnosed with type 2 diabetes, which is the type of diabetes Invokana and the other drugs are approved to treat. However, due to a lack of adequate warnings, Public Citizen indicates that Invokana, Farxiga, Jardiance and other SGLT-2 inhibitors are still often prescribed “off label” to Type 1 diabetics, who are often born with the disease.
“For several years, the FDA has become increasingly aware of serious life-threatening diabetic ketoacidosis caused by these drugs, when prescribed for Type 1 diabetes patients,” Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group who drafted the petition, said in a press release. “It’s long overdue, but the agency must explicitly oppose the use of these drugs for patients with Type 1 diabetes with a prominent boxed warning. Further delay guarantees additional, preventable drug-induced diabetic ketoacidosis for these patients.”
In December 2015, the FDA required drug makers to add new diabetic ketoacidosis warnings to Invokana and similar drugs, indicating the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting. However, the petition indicates that these prior warnings do not go far enough to alert doctors and consumers to the serious risk faced by Type 1 diabetics in particular.
Public Citizen notes that the FDA has received 550 reports of diabetic ketoacidosis in patients with Type 1 diabetes who were treated with SGLT-2 inhibitors. Of those reports, 411 cases resulted in hospitalization and 68 were considered life-threatening.
The group also noted that eight randomized, placebo-controlled clinical studies found Invokana and similar drugs increased the risk of diabetic ketoacidosis in Type 1 diabetics by a factor of three. As a result, the FDA has refused to approve the drugs for use by Type 1 diabetics, but doctors still often prescribe them “off-label”, which doctors are allowed to do.
Invokana Health Risks
Invokana (canagliflozin) was the first member of this new class of diabetes drugs, which work in a unique way by impacting some normal kidney functions. Other members of this class now include Invokamet, Jardiance, Farxiga, Xigduo and others, but Invokana has remained the biggest seller, amid aggressive marketing.
As more and more diabetics have switched to the new drug since it hit the market in 2013, a steady stream of Invokana lawsuits were filed in courts nationwide, and the FDA has required the drug maker to release several warning updates in recent years.
In June 2016, the FDA again required additional warnings about the link between kidney risks and Invokana and other drugs from its class, indicating that the medications may increase the risk of acute kidney injury and other severe health problems.
In May 2017, FDA required the makers of Invokana to specifically to add warnings about amputation risks, adding information to the drug label about the increased incidence of leg, foot and toe amputations. That warning was only required for Invokana, and manufacturers of other SGLT-2 inhibitors have suggested that Invokana leg and foot amputation problems were unique to that drug, maintaining that the same risks were not seen among users of their medications.
In August 2018, the FDA issued a drug safety communication about the risk of Fournier’s gangrene from Invokana, Invokamet and similar diabetes drugs. Incidents of the serious genital infections, also known as necrotizing fasciitis of the perineum, can result in the disintegration of flesh and can be life-threatening.
Following several years of litigation, Johnson & Johnson and Janssen have reached Invokana settlements to resolve most of the litigation previously filed over earlier failures to adequately warn about the diabetic ketoacidosis risk.