FDA Warns Amputation Risk Among Patients Taking Invokana
The diabetes drugs Invokana® and Invokamet® were met with praise when they were released a few years ago, hailed as the first FDA-approved drugs to significantly lower the levels of A1C, a measure of a patient’s average level of blood sugar or glucose. A recent alert from the agency now warns patients who take these drugs that they may be at an increased risk for leg and foot amputations as a result of the medications’ side effects.
Invokana® Side Effects
The alert was issued following the release of preliminary data from the ongoing CANVAS clinical trial of about 4,500 patients with diabetes which was initiated in 2009. Patients enrolled in CANVAS were randomly chosen to receive a placebo of Invokana® each day during the trial period. After one year, the researchers found about seven out of 1,000 patients taking Invokana® required an amputation compared to about three out of 1,000 in the placebo group.
Both Invokana® and Invokamet® contain an agent called canagliflozin, which helps lower blood sugar by removing more glucose through the urine. The drug’s manufacturer, Janssen Pharmaceuticals, has warned the drug mechanism increases urine output, and therefore can cause dehydration and lower levels of blood volume, which in turn can lead to circulation issues and, ultimately, amputation. Although the drug is too recent to have reliable long-term safety data, so far the FDA has warned of several potential Invokana® side effects including an increased risk of bone fractures, kidney failures, infections, and sepsis, in addition to the current alert regarding amputations.
In its alert, the FDA urged patients taking Invokana® to pay special attention to any changes or issues developing in their feet or legs, including pain, tender areas, sores or infections, and notify their doctors immediately if they notice these or any other changes.
Diabetes and Amputation Risks
About 15 % of people with diabetes will develop a foot ulcer at some point, according to the American Podiatric Medical Association, and as many as a quarter of those people will require an amputation as a result of damage to the circulatory and nervous systems. At the Foot & Ankle Clinic, Dr. Sigal offers patients with diabetes the most advanced diagnostic and care options to help each patient understand their risks and prevent long-term damage to their feet. Our clinical trials aim to help those with diabetes reduce their risk of amputations and other diabetes-related issues, allowing them to live a healthier, more functional life. If you’re concerned about Invokana® side effects or if you’d like to learn more about the clinic and Dr. Sigal, call our office at (213)365-0793 and schedule your consultation today.