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FDA Requires New Label for Invokana Foot and Leg Amputation Risks

FDA Requires New Label for Invokana Foot and Leg Amputation Risks

PillsFollowing the conclusion of two clinical trials, regulators with the Food and Drug Administration (FDA) have required Johnson & Johnson to add new warnings to the label of Invokana, a medication used to treat patients with Type 2 diabetes. The results of those trials found that patients taking Invokana, or canagliflozin, experienced foot and leg amputations at twice the rate as patients who were administered a placebo.

According to the FDA, Johnson & Johnson will now have to warn consumers about these risks using a boxed warning, the most serious warning available under FDA guidelines.

Invokana has made headlines in recent months and years over a number of lawsuits filed by consumers who took the medication and experienced a number of serious adverse health effects, including kidney failure, heart attack, and stroke. The medication has also been associated with ketoacidosis, a life-threatening condition that occurs when there isn’t enough insulin in the body. Invokana is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

The FDA has issued several other warnings regarding Invokana prior to the boxed warning for leg and foot amputations. This includes a revised warning in 2015 associating the drug with increased risks for ketoacidosis and serious urinary tract infections that may lead to damage or failure of the kidney.

Since Invokana has become a publicly available medication, there have been numerous reports of injuries and serious infections associated with the drug. As a result, many of these victims have filed lawsuits in an effort to hold Johnson & Johnson accountable for failing to ensure the safety of its products before making them available to the public.

At Biren Law Group, our personal injury attorneys dedicate their careers to fighting on behalf of the injured and the wronged, including those who have been harmed as a result of defective drugs and drug manufacturers that place profits over people. If you or someone you love has experienced adverse health effects after taking Invokana, you may have grounds to pursue a personal injury lawsuit. Our legal team is readily available to help you learn more about your rights and how we can help during a free consultation.

Contact us to speak with a member of our legal team.

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