FDA Requires Invokana Black Box Warning For Increased Risk of Leg/Foot Amputations

162017_132140396847214_292624_nThe FDA issued a safety alert on May 16, 2017 regarding Invokana (canagliflozin), a medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. after the final results from two clinical studies showed an increased risk of leg and foot amputations associated with the drug. The FDA is requiring a Boxed Warning regarding the risks.

The two clinical trials showed that leg and foot amputations occurred about twice as often in patients treated with Invokana (canagliflozin) compared to patients treated with placebo. The studies further found that amputations of the toe and middle of the foot were the most common amputations but amputations involving the leg, below and above the knee also occurred. Some patients had more than one amputation, and some patients had amputations involving both limbs.

Invokana is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that works by lowering blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

The FDA safety alert warns patients taking Invokana to notify their health care professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet. The FDA safety alert further advises that health care professionals should consider factors that may predispose patients to the need for amputations such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, before prescribing Invokana, and that they should monitor patients taking Invokana for the signs and symptoms of complications and discontinue its use if these complications occur.

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One of the clinical studies found that over a year’s time, the risk of amputation for patients in the trial were equivalent to 5.9 out of every 1,000 patients treated with Invokana, compared to 2.8 out of every 1,000 patients treated with placebo.

The other clinical study found that over a year’s time, the risk of amputation for patients in the trial were equivalent to 7.5 out of every 1,000 patients treated with Invokana, compared to 4.2 out of every 1,000 patients treated with placebo.

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Invokana is contraindicated for patients with a history of a serious hypersensitivity reaction to Invokana, such as anaphylaxis or angioedema, and for patients with severe renal impairment, end-stage renal disease, or patients on dialysis. Invokana is not recommended for patients with type 1 diabetes or for treatment of patients with diabetic ketoacidosis.

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This entry was posted on Thursday, June 15th, 2017 at 5:15 am. Both comments and pings are currently closed.

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