On May 18, 2016, the FDA issued a safety communication that warns of increased risk of leg and foot amputations with Invokana and Invokamet. These drugs are marketed by Janssen Pharmaceuticals (a division of Johnson & Johnson) and contain the SGLT2 inhibitor canagliflozin. SGLT2 inhibitors are used to treat Type 2 diabetes by causing the kidneys to remove excess glucose from the body through the urine.
The safety warning is based on analysis of an ongoing clinical study which showed “amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo…” The study is sponsored by Janssen (the manufacturer of the drugs) and is aimed at assessing major adverse cardiovascular events with canagliflozin, as well as evaluating its overall safety. As early as March 2016, Janssen informed the European Medicine Agency (EMA) – the EU equivalent to the FDA – about the increased risk of lower limb amputations. The increased risk “was seen early in the [Janssen-sponsored] study” and “was observed independent of predisposing risk factors.”
The FDA warning also urges patients to notify their doctors immediately “if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.” Infections and ulcerations affecting the lower limbs can lead to amputations.
The FDA is currently investigating this newest and potentially serious safety issue associated with Invokana/Invokamet and is planning to provide additional information in the future. The Agency has already issued two prior warnings and has approved safety updates to the labels of all SGLT2 inhibitors alerting about other serious risks, such as ketoacidosis and urinary tract infections (urosepsis and pyelonephritis).
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If you have suffered from one of these serious conditions after taking Invokana or other SGLT2 inhibitors, our experienced defective pharmaceutical lawyers at Kaiser Gornick LLP can help you explore your options for recovering compensation. We are a leading product liability litigation firm that has successfully recovered hundreds of millions of dollars for clients against big companies and pharmaceutical giants. Start your case on a no recovery, no fee basis.