Health regulators have required Johnson & Johnson to add a new warning to its diabetes drug Invokana over increased risk for foot and leg amputations.
Higher Incidence Of Leg And Foot Amputations In Diabetic Patients Who Use Invokana
The U.S. Food and Drug Administration said on Tuesday that the final results from two clinical trials of the diabetes drug showed that leg and foot amputations were significantly higher in those who use it.
The FDA said that the trials showed amputations occurred about twice as often in type 2 diabetes patients who were treated with the medication also called canagliflozin, as those who were given placebo.
"The 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) - showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo," the FDA said in a statement.
The most common amputations in patients as observed in the trials were of the toe and middle of the foot. Amputations of the leg, below and above the knee also happened and some patients required more than one amputation.
The FDA said that the new warnings need to include a boxed warning, which is reserved for drugs with most serious possible adverse events.
Invokana belongs to a new class of drugs for type 2 diabetes known as SGLT-2 inhibitors, which works by removing excess blood sugar through the patient's urine. It is recommended for use by diabetic adults along with diet and exercise to reduce levels of blood sugar.
The federal health agency urged patients to inform their healthcare professionals if they develop sores or ulcers, new pain or tenderness, or infection in their legs and feet. Doctors, on the other hand, are advised to consider factors that can predispose patients to amputations before starting the treatment.
Risk factors include diabetic foot ulcers, peripheral vascular disease, and a history of amputations. Health care professionals are also urged to monitor patients who receive the drug for signs and symptoms and to discontinue the drug if complications occur.
Diabetes In United States
Figures from the U.S. Centers for Disease Control and Prevention showed that more than 29 million Americans have diabetes. The American Diabetes Association also revealed that black people have 1.7 higher chances of contracting diabetes compared with white people.
"Compared to the general population, African Americans are disproportionately affected by diabetes: 13.2 [percent] of all African Americans aged 20 years or older have diagnosed diabetes," ADA said.
The condition is known to hamper the body's ability to produce or respond to the hormone insulin, which leads to abnormal metabolism and increased blood glucose levels.
Diabetes, a lifestyle disease, is the seventh leading cause of death in the United States.The condition is associated with stroke, heart disease, blindness, and kidney failure. Signs and symptoms of diabetes include blurred vision, extreme fatigue, feeling thirsty, slow healing of minor wounds, and frequent need to urinate.