FDA Warns of Amputations Connected to Certain Diabetes Drugs

Posted by Firm Staff on Jun 15, 2017 10:48:27 AM
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Serious side effects, including leg, foot, and other amputation, have been associated with a new class of diabetes drugs known as SGLT-2 inhibitors. Accordingly, the FDA has required black boxed warnings for amputation risks for glucose-controlling medications such as Invokana.



Approved in 2013, Invokana is prescribed with the intention of lowering blood sugar levels in adults with type 2 diabetes. However, in May 2017 the FDA required the manufacturer of this diabetes drug to include a black box warning for leg, foot, and other amputation risks. This safety communication comes after the FDA strengthened warnings in 2015 for Invokana’s association with diabetic ketoacidosis and an increased risk of severe kidney complications.


Black boxed warnings are reserved for the most serious possible adverse events. Before a new drug hits the market, it is the responsibility of its manufacturer to ensure that proper testing is performed and any drug risks and alerts are made public. When these standards are not upheld, drug makers should be held accountable.


If you or a loved one has taken Invokana or another qualifying type 2 diabetes drug and experienced an amputation, contact The Law Offices of Foster & Houston. Call us today at 1-800-943-3071 or simply fill out the contact form.


For more information about SGLT-2 inhibitors, FDA warnings about these diabetes drugs, and severe symptoms to be aware of, visit our website.


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