The U.S. Food and Drug Administration has issued a third set of warnings about serious adverse events that may occur after taking the antidiabetic medication, Invokana. The first warning had been issued in May of 2015, with the third safety announcement coming less than 7 months later, in December of 2015.
The May 2015 warning was prompted after the agency received 20 serious adverse event reports of severe diabetic ketoacidosis which required hospitalization occurring in patients who had taken Invokana or similar medications. In October, the agency required that Invokana’s manufacturer add information about the potential for bone fracture due to decreasing bone density in elderly patients.
The most recent December safety announcement increased the urgency of the original ketoacidosis warning, indicating that the FDA had received an additional 53 ketoacidosis reports for a total of 73 serious ketoacidosis occurrences requiring hospitalization.
In addition to the increased number of ketoacidosis reports, the FDA stated that they have received notification of 19 severe urinary tract infection events of urosepsis or pyelonephritis which required hospitalization. Some of these patients experienced kidney failure and required dialysis.
As part of the announcement, the agency stated that manufacturers of SGLT2 medications, including Invokana, have been required to include additional ketoacidosis and urinary tract warnings on prescribing information and labeling of the medications. They are also mandating that manufacturers conduct additional post-marketing studies over a 5-year period, regarding the increased risk and long-term safety of the medications. The FDA has encouraged that all adverse events regarding Invokana and SGLT2 inhibitors be reported to the agency using the MedWatch system.
Invokana is not the only antidiabetic medication facing scrutiny. Other member of the SGLT2 inhibitor class including Farxiga and Jardiance, as well as combinations Invokamet, Xigduo XR and Glyxambi are under similar constraints and several other types of diabetes medication have recently come under fire due to serious side effects.
Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, are facing hundreds of Invokana lawsuits due to serious injury caused by Invokana. Patients who have been injured may be eligible for compensation for medical costs, lost wages and pain and suffering.
Invokana was estimated at $1.2 billion in sales last year.
Food and Drug Administration, (15 May 2015), Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood, U.S. Food and Drug Administration, accessed on 10 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm475463.htm
Food and Drug Administration, (10 September 2015), FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density, U.S. Food and Drug Administration, U.S. Food and Drug Administration, accessed on 10 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm461449.htm
Food and Drug Administration, (04 December 2015), Drug Safety Communication: FDA revised labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infection, U.S. Food and Drug Administration, U.S. Food and Drug Administration, accessed on 10 February 2015 http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm