Just months after launching an investigation of Invokana and amputations, a European regulator has announced that it will expand the scope of its probe to include a number of other SGLT2 inhibitor Type 2 diabetes medications. According to a report from MedScape.com, the European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has determined that the potential risk may extend to all additional medications in the class.
In addition to Invokana, SGLT2 inhibitors currently available in Europe include Invokamet (sold as Vokanamet), Farxiga, Xigduo XR and Jardiance. These medications lower blood sugar in Type 2 diabetics by inhibiting the absorption of glucose by the kidneys, thus allowing it to be eliminated from the body via urine.
In April, PRAC announced that it was investigating a potential link between canagliflozin (the active ingredient in Invokana and Invokamet) and lower limb amputations, mostly involving the toes. The safety review was launched after interim data from the Canagliflozin Cardiovascular Assessment Study (CANVAS) found that such amputations occurred nearly twice as often in patients treated with canagliflozin compared to those who received a placebo.
The U.S. Food & Drug Administration (FDA) announced a similar investigation for Invokana and Invokamet in May.
Invokana was approved by the FDA in March 2013, and was the first SGLT2 inhibitor to come to market. Since their introduction, these medications have been the subject of multiple FDA safety alerts. In December 2015, for example, the agency ordered the drug’s manufacturers to add new warnings to their product labels regarding the possible risk of ketoacidosis, as well as a potential association with serious urinary tract infections that could lead to kidney complications.
Just last month, the FDA announced that the labels for Invokana, Invokamet, Farxiga and Xiduo XR would be modified to strengthen existing warnings for kidney complications. According to the FDA’s Drug Safety Communication, the medications had been linked to more than 100 reports of acute kidney injury, the majority of which involved canagliflozin.
In September 2015, the FDA announced that the labels for Invokana and Invokamet would be updated to include information about a possible increased risk of bone fractures