The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is asking Johnson & Johnson and its subsidiary Janssen Pharmaceuticals to provide more information to help in its ongoing investigation into whether the companies’ top selling diabetes drug Invokana increases the likelihood of lower-limb amputations.
The investigation was triggered by the ongoing clinical trial Canagliflozin Cardiovascular Assessment Study (CANVAS) involving about 4,000 type 2 diabetics. (Canagliflozin is the chemical name for Invokana.) Patients in the CANVAS study were given either 100 mg or 300 mg of Invokana daily or a placebo. The study showed that in every 1,000 patient-years among those taking the 100 mg of Invokana, there were seven cases of lower-limb amputations.
AstraZeneca plc and Eli Lilly and Co, makers of Farxiga, and Boehringer Ingelheim, maker of Jardiance, may also be asked to provide data, as those drugs are in the same class as Invokana. The U.S. Food and Drug Administration (FDA) is currently conducting a classwide investigation into lower limb amputation risk, specifically foot and toe amputations.
Invokana has had a checkered past in the three years since it hit the market in both the U.S. and the U.K. Since its approval, Janssen has had to update the drug’s safety label to include new or stronger warnings for serious urinary tract infections, ketoacidosis, bone mineral loss, bone fractures, and acute kidney injury.
Both the FDA and the EMA will be announcing the results of their individual findings on amputation risk once their investigations are complete.
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