Patients in a clinical trial studying Janssen Pharmaceuticals’ diabetes drugs Invokana and Invokamet were roughly twice as likely to undergo amputations as patients taking a placebo, the U.S. Food and Drug Administration reported last month. The FDA said in a safety alert that the equivalent of five of every 1,000 patients taking a 300-milligram daily dose of the active ingredient canagliflozin needed amputations. In addition, the equivalent of seven of every 1,000 patients taking a 100-milligram daily dose needed amputations, compared with only three of every 1,000 patients taking a placebo. The amputations affected toes, feet and legs.
FDA officials said they are working to determine whether canagliflozin really does elevate the risk of amputation, and that patients shouldn’t stop taking the drug without first consulting a doctor. The agency said:
Patients taking [canagliflozin] should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.
Canagliflozin is the only active ingredient in Invokana and is combined with another active ingredient, metformin, in Invokamet. Invokana and Invokamet were approved in 2013 and 2014, respectively, and are used to control blood sugar levels in patients with Type 2 diabetes. The trial, which is examining how canagliflozin affects cardiovascular health, has followed patients for 4.5 years and is expected to continue. A similar clinical trial that has followed patients for nine months hasn’t found the same elevated risks of amputation, the FDA said.
In a statement, Janssen officials said they “remain confident that canagliflozin is an important treatment option for people with Type 2 diabetes.” The uptick in amputations has not been observed in a dozen other Phase III and Phase IV trials or in postmarketing safety reports, the company officials added. Admittedly, there is a risk of amputations for diabetics because the disease can cause nerve damage and impair blood circulation. The Mayo Clinic confirms that. However, the FDA report gives cause for concern.
Invokana was the first in a class of drugs known as sodium-glucose cotransporter 2, or SGLT2, inhibitors. It was approved amid concerns about cardiovascular health and bone safety, and the FDA has since updated Invokana’s and Invokamet’s warning labels to reflect risks of bone fractures. The drugs’ labels – as well as the labels of other SGLT2 inhibitors – have also been revised to disclose risks of a blood disorder and urinary tract infections.
Other drugs in the class include AstraZeneca PLC’s Farxiga and Xigduo XR, dapagliflozin and a dapagliflozin-metformin combination respectively, and Boehringer Ingelheim GmbH and Eli Lillyand Co.’s Jardiance and Glyxambi, empagliflozin and an empagliflozin-linagliptin combo respectively.
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