After extensive studies and negative findings, the FDA issued a Black Box Warning for patients taking the type-2 diabetes medication, Invokana. As a result of the findings, the Black Box Warning and FDA Safety Alert now disclaims that users of Invokana double the risk of leg, foot and toe amputations. The final results of a study comparing Invokana users to placebo users show that the amputation risks are actually twice as high.
If you or a loved one had a toe amputation, foot amputation, leg amputation or even death while taking Invokana, you should Contact the Invokana Amputation Lawyers of Peiffer Wolf Carr & Kane for a FREE Consultation by filling out an online Contact Form or by calling 833-INVOKANA today. We are committed to fighting against Invokana, Janssen and Johnson & Johnson on behalf of those injured by Invokana. We believe that if you were hurt or injured by Invokana, you Deserve Compensation.
Invokana is a medication with the active ingredient canagliflozin, which is meant to treat type-2 diabetes. Invokana is supposed to reduce blood sugar by increasing the amount of sugar and glucose that is lost through urination. The active ingredient is supposed to block the absorption of sugar and glucose back into the bloodstream after being filtered through the kidneys. Then, the glucose and sugar will be excreted through urine.
Upon results from the CANVAS study, the FDA release a Safety Alert stating, “In CANVAS, the risk of lower limb amputations was 5.9 amputations per 1,000 patients per year for canagliflozin compared to 2.8 amputations per 1,000 patients per year for placebo. In CANVAS-R, the risk of lower limb amputations was 7.5 amputations per 1,000 patients per year for canagliflozin compared to 4.2 amputations per 1,000 patients per year for placebo.”
The findings in these studies triggered the FDA to issue the most severe “Black Box” warning label for Invokana. The final results from both studies confirm that Invokana may DOUBLE the risk of toe, foot, or leg amputation. The May 16, 2017 “Black Box” warning follows a prior safety alert issued in May of 2016 and stresses higher level of concern. The new warning requires that Invokana’s increased risk of amputation be printed at the top of prescribing information and enclosed in a thick black box. If you or a loved one had a toe amputation, foot amputation, leg amputation or even death while taking Invokana, please Contact the Invokana Lawsuit attorneys of Peiffer Wolf Carr & Kane for a FREE Consultation by filling out an online Contact Form or by calling 833-INVOKANA today.
FDA Safety Communications: Trial Data Summary
The FDA summarized its safety alert by stating, “An approximately two-fold increased risk of lower limb amputations associated with canagliflozin (Invokana) use was observed in two large, randomized, placebo-controlled trials evaluating patients with type 2 diabetes who had either established cardiovascular disease or were at risk for cardiovascular disease. These trials were CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus). Patients in the CANVAS and CANVAS-R trials were followed for an average of 5.7 and 2.1 years, respectively.”
The CANVAS and CANVAS-R trials were actually intended to observe and assess Invokana’s long-term effects on patients’ hearts. However, the observation period uncovered something worse: increased risk of toe, leg, and foot amputations. In fact, the occurrence was twice as often for patients taking Invokana, as compared to patients taking a placebo.
Patients were tracked and observed for five years, and the amputation occurrences per year were as follows:
7 out of 1,000 patients taking 100 mg. of Invokana daily
5 out of 1,000 patients taking 300 mg. of Invokana daily
3 out of 1,000 patients taking a placebo
Johnson & Johnson has repeatedly appeared in the headlines for issues with transvaginal mesh, metal hip implants, talcum powder cancer claims, and now Invokana. If you or a loved one had a toe amputation, foot amputation, leg amputation or even death while taking Invokana, please Contact the Invokana Lawsuit attorneys of Peiffer Wolf Carr & Kane for a FREE Consultation by filling out a Contact Form or by calling 833-INVOKANA today. We are ready to fight Janssen and Johnson & Johnson on your behalf. Join the Fight!