Several Healthcare providers in California have decided to stop prescribing Invokana and Invokamet after the U.S. Food & Drug Administration (FDA) warned that their active ingredient – canagliflozin – had been linked to an increased risk for lower limb amputations.
According to KPBS in San Diego, physicians in the Sharp HealthCare system began switching patients from canagliflozin-containing medications after the FDA issued its warning in May. Type 2 diabetics with pre-existing risk factors, such as prior amputations, are being prescribed alternate drugs.
The Scripps Health system’s hospital pharmacy and therapeutics committee recently voted to remove canagliflozin from its list of drugs used for hospitalized patients. An endocrinologist on staff at Scripps Mercy told KPBS that his five-physician practice has removed all canagliflozin samples from its shelves and is no longer prescribing the medication.
Invokana (canagliflozin) was approved by the FDA in March 2013 and was the first SGLT2 inhibitor cleared by the agency to treat Type 2 diabetes. Invokamet (canagliflozin and metformin) was approved the following year.
In May, the FDA announced that a new Black Box Warning – the strongest possible safety notice – regarding a risk of lower limb amputations would be added to the labels for all canagliflozin-containing medications. The agency acted after final results from two clinical trials indicated that leg and foot amputations occurred about twice as often in canagliflozin patients compared to those treated with placebo. The most common amputations involved the toe and middle of the foot. However, leg amputations, below and above the knee, also occurred.
In December 2015, the FDA announced that the labels for all SGLT2 inhibitor drugs, including Invokana and Invokamet, would be updated to include information about diabetic ketoacidosis, a dangerous condition that can lead to diabetic coma or death when not recognized and treated appropriately.
The labels for Invokana, Invokamet and several other SGLT2 inhibitors were updated yet again in June 2016, after the medications were linked to more than 100 reports of acute kidney injury.
Court documents indicate that more than 280 Invokana and Invokamet lawsuits are now pending in a federal multidistrict litigation currently underway in the U.S. District Court, District of New Jersey, all of which were filed on behalf of individuals who allegedly suffered diabetic ketoacidosis or kidney damage due to treatment with the medications.
Hundreds of additional cases have been filed in various state courts around the country, including Pennsylvania, California and New Jersey, while several Invokana class action claims are pending in Canada.
The federal Invokana litigation is expected to convene a series of bellwether trials beginning in September 2018. These trials will act as test cases, and could provide insight into how juries might rule in similar legal claims involving the drugs.