The risk of amputation has led to an Invokana warning on this popular diabetes drug. The U.S. Food and Drug Administration has stated that the high risk of amputation has prompted a new Invokana warning label.
These black box warnings will explain that patients may have a much higher risk of needing their feet or legs amputated.
An alert was first sent by the Food and Drug Administration over a year ago that those patients involved in clinical trials for Invokana were twice as likely to require amputations when compared with a placebo drug.
The final results from those two clinical trials ultimately led to an Invokana warning label to advise patients about the risks before they begin taking the drug.
Study Shows Higher Chance of Amputation for Invokana Users
Nearly six out of 1,000 patients on Invokana required an amputation within one year, even though the placebo’s numbers were 2.8 out of 1,000 patients. Many of the amputations that prompted the need for an Invokana warning label involved a toe or a foot, although some of these procedures also involved legs.
The FDA also identified that some of the patients involved in these research studies needed more than one amputation. Any patients who had previously had amputations prior to beginning the drug were most likely to require another one.
Invokana was one of the first in a class of medications known as an SGLT-2 inhibitor.
When it was initially brought on to the market, there were significant concerns about bone fractures and cardiovascular health.
The Invokana warning labels were already updated to disclose blood disorder risks and a higher chance of urinary tract infections.
Anyone who suddenly develops a side effect that causes harm or serious injury may be eligible to participate in a lawsuit, and a growing number of patients are taking action against the manufacturers of these allegedly dangerous medications.
A defective drug lawsuit may be the only way for an injured patient to recoup compensation for pain, suffering, and associated medical costs in their case.
Similar Drugs May Cause Same Side Effects
Other medications include Jardiance, Glyxambi, Xigduo, and Farxiga manufactured by AstraZeneca. Those patients who begin taking a medication without being fully aware of the risks may become surprised to suffer devastating side effects down the road.
Patients who have been negatively affected by a drug such as Invokana or have had to go through amputations unnecessarily may have grounds to participate in a lawsuit.
Many patients who have already had a foot, toe or other limb amputated may not immediately draw the connection between the use of Invokana and their requirement for an amputation.
Scheduling a consultation with the experienced attorney at McDonald Worley may be the only way for a patient who has been negatively affected to figure out their next steps and to move forward with a legal claim.