The U.S Food and Drug Administration said on Tuesday that there is the need that Johnson & Johnson (J&J) add some new precautions to its diabetes drug, Invokana, about the possibility of foot and leg amputation.
How did this come?
Type 2 diabetics were put to the test and were treated with J&J’s product, Invokana, otherwise known as Canagliflozin, it was recorded that foot and leg amputation occurred as twice as those treated with placebo. This was made known by FDA in an announcement published on its website. FDA on its post said that the precaution includes a boxed warning, kept for the most important possible contrary events.
FDA recorded that results from a clinical trial portrayed that the probability of diabetics treated with Invokana over the years was about 5.9 out of 100, unlike the case of Placebo which showed that about 2.8 out of 1000 people living with diabetes face the risk of foot or leg amputation.
Sequel to the first trial, a second test showed that with Invokana, the risk of amputation was about 7.5 out of every 100 patients, and in the case of Placebo, about 4.2 out of every 1000 patients.
What is Invokana?
Invokana is a drug by J&J that falls under the somewhat new class of type 2 diabetes medication known as SGLT-2 inhibitors. These set of medications help to remove excess sugar in the blood via urine. Other drugs that fall in this class are Farxiga by AstraZeneca Plc, Eli Lilly, and Co’s Jardiance.
The FDA emphasized that although amputation of the leg, above and below the knee occurred, the surgical removal of the middle of the foot and the toe were rampant. Then again, if type 2 diabetes is left untreated, it could deteriorate to heart and kidney problems.