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FDA Alert: Invokana foot amputations

Clinical trial shows increased risk of foot and leg amputations while taking Invokana

FDA investigating possible link between drug and foot amputationsThe Food and Drug Administration recently released a Drug Safety Communication alerting patients about an interim clinical trial that shows patients taking Invokana were twice as likely to undergo a foot or leg amputation while taking Invokana, compared to a placebo. This announcement is just the latest in a series of safety alerts made by the FDA concerning the type 2 diabetes drug Invokana (canagliflozin).

While the FDA has not definitively said whether or not Invokana increases the risk of toe, foot, and leg amputation, it none the less has issues the Safety Alert and will investigate the situation. The FDA warns patients experiencing any “new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

According to the FDA, the interim study shows the risk to patients taking the diabetes drug increased substantially. The risk of amputation of the feet or leg equated to:

  • 7 out of every 1,000 patients treated with 100 mg daily of canagliflozin
  • 5 out of every 1,000 patients treated with 300 mg daily of canagliflozin
  • 3 out of every 1,000 patients treated with placebo

Invokana amputation lawsuits

Patients across the country have already filed Invokana injury lawsuits alleging canagliflozin caused severe kidney and renal damage, heart attack, stroke, and bone fractures. An Invokana class action lawsuit was also filed in Canada, alleging the drug put thousands of patients at risk of severe injury.

If you or a loved one suffered a serious injury while taking Invokana, contact The Cochran Firm, D.C. for an absolutely free legal consultation about your case. Our experienced team of Invokana injury lawyers prepared to help you and your family get the compensation you deserve.

Call us at 202-682-5800 during business hours or at 1-800-THE FIRM (843-3476) to reach us 24 hours a day, seven days a week. You may also fill out an online contact form' with information about your case and a legal representative will contact you back.


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The Cochran Firm handles Medical Malpractice, Catastrophic Personal Injuries, Motor Vehicle Accidents & Wrongful Death Claims for clients throughout the United States of America. The information on this website does not constitute legal advice nor form an attorney-client relationship. Please contact The Cochran Firm today to schedule a free consultation.
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