Warnings and Precautions for Invokana (Canagliflozin)
Written By: Rheingold, Giuffra, Ruffo & Plotkin, LLP,
Invokana has now been associated with several amputations. As of May 2017, the FDA has sounded the alarm by adding warnings for this severe side effect. As observed in the Canagliflozin Cardiovascular Assessment Study (CANVAS) and the CANVAS renal-end-points trial (CANVAS-R), “two large, randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular disease or were at risk for cardiovascular disease”, and the risk of amputation is highest for patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Invokana is a blockbuster diabetes drug, and it was already under FDA observation for the deadly side effect of ketoacidosis. Amputations have occurred at the toes, midfoot, legs, lower limbs, and the area above or below the knees. The most common medical scenarios which may necessitate amputation are lower limb infections, gangrene, and diabetic foot ulcers. It is advised patients are informed of the risks associated with Invokana and are counseled about how essential it is to maintain regular foot care.
There are several other life-threatening and adverse reactions which may also result from the use of this drug. These include lower limb amputations, hypotension, ketoacidosis, acute kidney injury and impairment in renal function, hyperkalemia, urosepsis, pyelonephritis, genital mycotic infections, and hypoglycemia with concomitant use with insulin and insulin secretagogues.
The FDA states it is crucial for patients receiving Invokana to be monitored by their doctors for signs and symptoms of infection, new pain, tenderness, sores, and ulcers involving the lower limbs. The risk for complications is increased with the use of this drug. Risk factors in patient history that may influence the need for amputations should be considered prior to taking Invokana. However, even if one considers these risks and monitors for symptoms of health complications, the risk of amputation and other consequences is still tangible.
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By: Queenie Cheng