In the News: Drug Safety May 18, 2017
FDA issues a safety warning related to diabetes medicine CANAGLIFLOZIN (Invokana, Invokamet, Invokamet XR)
On March 16, 2017, the Food and Drug Administration (FDA) issued a Drug Safety Announcement related to the diabetes medicine CANAGLIFLOZIN based on data from two large clinical trials. CANAGLIFLOZIN is used to treat individuals with type 2 diabetes and is sold under the brand names Invokana, Invokamet, and Invokamet XR.
According to the FDA announcement, the new clinical trial data shows that patients taking the drug CANAGLIFLOZIN were at an increased risk of leg and foot amputations. Specifically, the studies showed that leg and foot amputations occurred about twice as often in patients treated with CANAGLIFLOZIN compared to patients treated with placebo, which is an inactive treatment.
In the study, the most common amputation was the toe and middle of the foot, although some patients required amputations further up their leg, both above and below the knee. There was also patients that required multiple amputations, and others that required some level of amputation on both legs.
The FDA advises patients that are currently taking CANAGLIFLOZIN to speak with their healthcare provider about any concerns or before they stop taking CANAGLIFLOZIN. If you have diabetes and are currently prescribed CANAGLIFLOZIN, you should speak with your healthcare provider before you stop taking CANAGLIFLOZIN. Most importantly, if you are taking CANAGLIFLOZIN and develop new pain or tenderness sores or ulcers, or infections in your legs or feet you should immediately notify the physician to discuss the possible risk.
If you are a physician that prescribes CANAGLIFLOZIN to patients for the treatment of individuals with type 2 diabetes the FDA recommends that you review your prescribing practices. Before giving the drug to patients, it is important to be informed of your patient’s medical history. The FDA warns the increased risk of amputation related to CANAGLIFLOZIN is more common in patients with a medical history that includes prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. If you have considered and discussed the risk with your patient and decided to prescribe CANAGLIFLOZIN, patients should be closely monitored for potential complications.
The FDA ask that patients and healthcare providers report any issues related to CANAGLIFLOZIN.
To read the FDA Safety Announcement or Report an issue follow the link below: