Johnson & Johnson’s Janssen Pharmaceuticals’ type 2 diabetes drug Invokana has taken some hits since March 2013 when it was approved for marketing in the U.S. by the Food and Drug Administration (FDA). Last May, the agency warned that the medication had been linked to cases of ketoacidosis, a serious condition in which too much acid builds up in the blood. Four months later, the FDA issued new warnings for Invokana over bone fracture risk and decreased bone density. Now, European regulators reviewing data from a large ongoing clinical trial say they found evidence that patients taking Invokana were more likely to have a toe amputated.
Type 2 diabetes is a chronic condition that can lead to other serious health issues including heart disease, kidney disease, cancer, dementia and amputations due to neuropathy. Those diagnosed with the condition must follow a strict diet for the rest of their lives. Many rely on medication, such as Invokana, to help regulate blood sugar levels in an effort to stave off complications. But these medications come with side effects.
Invokana is one of the newer type 2 diabetes drugs on the market, and new and emerging adverse reactions are just beginning to come to light. The recent discovery of increased toe amputations in Invokana patients has prompted the European Medicines Agency (EMA) to request additional data from Johnson & Johnson and Janssen to better determine if the drug puts users at greater risk for lower limb amputations.
The clinical trial reviewed by the EMA involved 4,000 patients with type 2 diabetes who have received the drug in either 100 mg or 300 mg daily doses of Invokana or a placebo. Researchers found that for every 1,000 patient years among patients taking the 100 mg dose, there were 7 cases of lower limb amputations.
The EMA is also considering asking for similar data from Astra Zeneca and Eli Lilly and Co.’s Farxiga and Boehringer Ingelheim’s Jardiance. Farxiga and Jardiance are in the same drug class as Invokana.
Source: Sonoran Weekly Review