The U.S. Food and Drug Administration (FDA) is requiring a black-box warning for Janssen Pharmaceuticals’ diabetes medications Invokana and Invokamet. The FDA said the drugs can increase the risk of patients needing to have their legs or feet amputated and that the drugs must have this very strong warning.
The FDA had first sent out an alert a year ago that patients in clinical trials for the drugs were twice as likely to need amputations as those on a placebo. Now the FDA, on May 16, issued the final results from two clinical trials. Canagliflozin, which the Johnson & Johnson unit sells as Invokana, Invokamet and Invokamet XR, is used to treat Type 2 diabetes. The tests revealed the following:
• According to the first clinical trial, known as CANVAS, 5.9 out of 1,000 patients on the drug needed an amputation over a year, while the placebo’s numbers were 2.8 out of 1,000 patients.
• The second trial, CANVAS-R, showed 7.5 out of 1,000 patients needed an amputation when on the drug compared to 4.2 on the placebo.
Most of the amputations involved the foot or a toe, with some others involving legs, the FDA said, adding that some patients needed more than one amputation. The FDA said in a safety communication:
Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Janssen said in a statement that patients who had amputations before starting the drug were most likely to need another one.
Invokana was the first in a class of drugs known as sodium-glucose cotransporter 2, (SGLT2) inhibitors. The drug 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 and Boehringer Ingelheim GmbH and Eli Lilly and Co.’s Jardiance and Glyxambi.
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