The U.S. Food and Drug Administration (FDA) has ordered Johnson & Johnson to add new warnings to its diabetes drug Invokana regarding the risk of foot and leg amputations. According to a news report, final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana (generic name: canagliflozin) as those given a placebo. The warnings include a boxed warning, which is reserved for the most serious possible adverse events. If you or a loved one has experienced an injury as a result of taking Invokana, do not hesitate to contact an experienced Invokana lawyer to help you.
What Is Canagliflozin?
Canagliflozin is a prescription drug, used along with diet and exercise to lower blood sugar in patients with type 2 diabetes. It is in a class known as sodium-glucose cotransporter-2 inhibitor or SGLT2. It works in the kidneys to remove sugar from the body via the urine. As a single medicine, it is known as Invokana. When it is combined with the diabetes drug metformin, it becomes Invokamet. In 2016, the FDA issued warnings about possible kidney injury associated with the medication calling for doctors to evaluate patients’ kidney function before taking the drug.
How Great Is The Risk Of Amputation When Taking Invokana?
The FDA noted that results of one clinical trial showed over the course of a year that the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000 compared with 2.8 out of 1,000 for patients given a placebo. A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana, compared with 4.2 out of every 1,000 patients given a placebo. The agency said amputations of toe and middle of the foot were most common, but amputations involving the leg, both below and above the knee also occurred.
It is important that patients are aware of these risks. Being aware of problems in the extremities is particularly important. The FDA advises those who are on the drug to contact their healthcare provider immediately if they notice new pain, tenderness, sores, ulcers or infections in the legs or feet. It is important not to stop taking medicine for diabetes or other conditions without first consulting with your doctor about the potential benefits and risks. Some people at a higher risk include anyone who had a prior amputation and those with nerve issues, peripheral vascular disease or foot ulcers.
Call Our Firm Today!
If you have suffered serious side effects as a result of taking Invokana, talk to an experienced lawyer about seeking and obtaining compensation for damages such as medical expenses, lost income and pain and suffering. Our personal injury law firm is working with some of the most experienced Invokana lawyers around the country who handle these cases regularly. We charge no legal fee unless you receive the settlement or award you are entitled to. Call us toll-free at 1-800-992-6878 for a no-cost consultation and case assessment.