The Food and Drug Administration (FDA) has concluded that canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, carries an increased risk for leg and foot amputations.
The new Boxed Warning, the strongest label the FDA can place on a prescription medication, will now inform patients about the risk of amputation from canagliflozin. According to final results from the CANVAS and CANVAS-R trials, leg and foot amputations occurred about twice as often in patients taking canagliflozin compared with patients taking placebo. Patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy were found to be at greatest risk; clinicians should consider these risk factors prior to initiating treatment with canagliflozin.
The FDA noted that most of the reports involve toes and the middle foot, but leg amputations above and below the knee occurred in the trials, as well as people who had multiple toes or both legs amputated.
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This information is an update to the May 18, 2016 MedWatch safety alert.
Leerink analyst Seamus Fernandez expects Lilly to benefit from an influx of Invokana patients transitioning to one of its diabetes meds, Jardiance.
Invokana is part of a class of diabetes drugs known as SGLT-2 inhibitors, which cause the kidneys to remove sugar from the body through urine and thereby lower blood sugar levels in patients with diabetes. It can cause hypotension, ketoacidosis, kidney problems, a large amount of potassium in the blood, urinary infections, high cholesterol, yeast infections, bone fractures, and low blood sugar if combined with other drugs for treating diabetes. The Canvas-R trial began in October 2013. Despite the increased risk of amputation, patients should not stop treatment for type 2 diabetes without discussing options with their providers, according to the release.
Canagliflozin use is associated with increased risk of toe, foot, and leg amputations. "We believe a dramatic impact on the class is unlikely", he said, noting that the company's situation "could be further mitigated by a directionally positive result" from the outcomes studies on CV risk reduction.