Just three years after its approval, the Type 2 diabetes medication, Invokana (canagliflozin), multiple warnings and safety alerts have already been issued due to serious concerns about the potential risks of the medication. Two recent events including FDA approval of Invokamet CR, a long-acting form of the combination drug that includes Invokana as one of the ingredients and recent changes in labeling to a similar drug, may increase the chance that more people will be harmed by the medication.
Since its approval, Invokana has caused a number of safety issues including an increased potential for kidney injury, a higher-than-normal rate of diabetic ketoacidosis, an increased rate of limb amputations and perhaps, more troubling, an increased risk of cardiovascular injury like heart attack or stroke. The approval of Invokamet CR and labeling changes approved for a similar drug, Jardiance, may add to the risks of Invokana.
FDA approvals affecting Invokana
Invokana was approved in November of 2013 over objections of a consumer advocacy group, Public Citizen who still lists the medication on their “Do Not Use” list. Despite growing evidence of increased risks for severe injury, manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, submitted and received an August 2014 approval of Invokamet, a combination drug containing Invokana and another anti-diabetic, metformin.
The company has continued with the Invokana line even though evidence regarding serious injury continues to mount, and in received approval for an extended-release version Invokamet XR in late September of 2016. This approval was received after a May 2016 FDA safety alert was issued which strengthened warnings about Invokana’s increased risk of kidney injury and required changes to the prescribing information on the medication. Multiple patients have been hospitalized and may have required hospitalization for renal failure and chronic kidney disease that occurred after Invokana was started.
In addition to the threat of kidney injury, Invokana was previously the subject of a May 2015 warning which indicated a link to a higher than expected rate of diabetic ketoacidosis. Other warnings have been issued for increased potential for bone fractures, a greater risk of the need for amputation of the extremities and to an increase in the incidence of cardiovascular events including heart attack and stroke
Unfortunately, confusion over heart attack potential may be on the horizon, putting more patients at risk. Another member of the SGLT2, Jardiance (empagliflozin) has received December 2016 approval to list a decreased risk of heart attack as part of its prescribing information but Invokana is not included in this approval.
Some professionals may be concerned that confusion may develop over Jardiance’s approval to list a decreased cardiac risk when Invokana, a member of the same medication class may increase heart attack risk. Careful attention must be paid to a patient’s cardiac history and patients should be advised to discuss all of their medical issues with their physician.
Johnson & Johnson’s continued push for Invokana and its progenitors Invokamet and Invokamet XR also means the more patients will be taking the medication and will potentially be under threat of serious adverse events after taking one of the Invokana line of medications.
Invokana’s manufacturer, Janssen and its parent company, Johnson & Johnson are already facing hundreds of lawsuits for serious injuries related to the medication’s use. These new developments may increase the numbers of Invokana lawsuits.
If you or a loved one have suffered from severe side effects after taking Invokana, you may be eligible for compensation through an Invokana lawsuit. Past medical injury lawsuits have resulted in settlements to cover medical costs, lost wages, and pain and suffering. Though each case is different, some patients receive settlement awards reaching into the tens or hundreds of thousands or even millions of dollars.