Tagged Articles

toe amputations 2 articles

EMA expands toe amputation risk investigation to other SGLT2 inhibitors

The European Medicines Agency (EMA) has extended the scope of its investigation into the risk of lower limb amputations with the type 2 diabetes drugs Invokana and Invokamet to include other drugs in the class. Invokana and Invokamet contain the active ingredient canagliflozin, which is in a class called sodium glucose cotransporter 2 (SGLT2) inhibitors. The EMA’s investigation will now also focus on other SGLT2 inhibitors such as dapagliflozin (which includes the brand names Farxiga and Xigduo XR) and empagliflozin (which includes the brand name Jardiance). The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) launched a safety review on canagliflozin in ... Read More

FDA: Invokana, Invokamet linked to foot, toe amputations

People who take the type 2 diabetes medication Invokana or Invokamet, both of which contain the active drug ingredient canagliflozin, are at an increased risk of foot amputations, mostly affecting the toes, the Food and Drug Administration (FDA) warned. The Safety Alert comes just weeks after the European Medicines Agency (EMA) announced that it was conducting an investigation into reports of lower limb amputations, specifically toe amputations, with the drug. The FDA said that results from an ongoing clinical trial found an increased risk of foot and toe amputations in patients treated with Invokana and Invokamet. The agency said it ... Read More