Amputation warning to be added to type 2 diabetes drugs sold in Europe

diabetes illus250x03 Amputation warning to be added to type 2 diabetes drugs sold in EuropeEurope’s Committee for Medicinal Products for Human Use (CHMP) announced it is endorsing the European Medicine Agency (EMA) Pharmacovigiliance risk Assessment Committee (PRAC) recommendations to add new warnings to the labels to a class of type 2 diabetes drugs called SGLT2 inhibitors alerting users to an increased risk for lower limb amputations, mostly affecting the toes.

The recommendations will be sent to the European Commission for a final legally binding decision that will stand for all drugs in the class sold throughout the European Union.

The EMA issued a statement stating, “Patients taking these medicines are reminded to check their feet regularly and follow their doctor’s advice on routine preventative foot care. They should also tell their doctor if they notice any wounds or discoloration, or if their feet are tender or painful.”

The warning would apply to the SGLT2 inhibitors canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga/Forxiga, Xigduo XR), and empagliflozin (Jardiance). Invokana was the first SGLT2 to hit the market, in 2013.

A review of CANVAS study data revealed an increased risk of lower limb amputations, particularly of the foot and toe, in patients treated with Invokana. The EMA launched an investigation, later expanding its probe to include all SGLT2 inhibitors.

The U.S. Food and Drug Administration (FDA) followed suit, launching an investigation into the claims with Invokana and Invokamet, but did not expand to include other drugs in the class. The FDA has yet to announce if it will require any regulatory actions such as new warnings added to the drug’s label.

Invokana and other SGLT2 inhibitors also have been linked to an increased risk of acute kidney injury and ketoacidosis, a serious condition in which too much acid builds up in the blood.

Source: Regulatory Affairs Professional Society