A British doctors’ group has released a new position statement calling on caregivers and patients to be aware of the potential for Invokana and other SGLT2 inhibitors to cause diabetic ketoacidosis, a potentially fatal condition. The new statement comes as hundreds of plaintiffs in the U.S. pursue Invokana lawsuits over this and other complications allegedly associated with its use.
In addition to Invokana, Type 2 diabetes drugs in the SGLT2 inhibitor class include Invokamet, Farxiga, Jardiance, Xigduo XR and Glyxambi. These drugs work by preventing the absorption of glucose by the kidneys, thus facilitating its removal from the body via urine. Since Invokana was first approved in 2013, use of the SGLT2 class has grown significantly. Just last year, the Institute for Safe Medicine Practices reported that the number of prescriptions dispensed had grown six-fold, from 336,000 in the first quarter of 2014 to more than 2 million in the final quarter of 2016.
Since coming to market, SGLT2 inhibitors have been the subject of multiple safety notices in the U.S. and abroad. In December 2015, the Food & Drug Administration (FDA) announced that the drug’s labels would be changed to reflect the potential for diabetic ketoacidosis, a serious condition caused by the build-up of toxic acids in the blood.
According to the Association of British Clinical Diabetologists (ABCD), the risk of ketoacidosis with SGLT2 inhibitors is relatively small, but its serious nature requires that doctors and patients be aware of risk factors associated with the condition. These include:
The statement notes that the majority of SGLT2 inhibitor patients who have experienced ketoacidosis suffered from adult-onset Type 1 diabetes. The medications should not be prescribed to these individuals. Type 2 diabetics with a severely impaired ability to produce insulin may also be at increased risk. The condition is also known to occur regardless of whether or not blood glucose levels are elevated.
The ACBD is recommending that SLT2 inhibitors be stopped in patients who develop ketoacidosis. The group also advises that treatment be suspended in individuals about to undergo surgery and who need to fast significantly before-hand, in those requiring emergency surgery, and those who have experienced extreme stress or trauma.
Patients taking SGLT2 inhibitors should avoid excessive alcohol intake or extremely low-calorie diets. Insulin reduction should be handled with care in those taking SGLT2 inhibitors if there is a risk that the patient may not be able to produce enough of their own insulin. Caregivers and patients should be aware of the symptoms associated with ketoacidosis, including abdominal pain, nausea, vomiting, fatigue, and labored breathing.
Hundreds of Invokana lawsuits are now pending in U.S. courts, all of which were filed on behalf of individuals who developed diabetic ketoacidosis, kidney problems and other complications allegedly related to use of the drug. Federal claims of this nature he been centralized in a multidistrict litigation now underway in the U.S. District Court, District of New Jersey.