Startling new Food and Drug Administration warnings about amputations and kidney failure suffered by type 2 diabetes patients using Invokana are triggering thousands of Invokana claims and lawsuits.
The FDA said amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs.
Victims of Invokana side effects may be able to seek compensation for injuries through Injuryhelpdesk.com, which provides references to a nationwide network of attorneys.
Free consultations are available for eligible Invokana victims seeking legal representation from attorneys who specialize in such cases and have successfully filed lawsuits based on the side effects of dangerous medications.
The FDA issued a Drug Safety Communication in May, 2017, after serious concerns were raised over Invokana side effects based on new data from two large clinical trials.
“The agency has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations,” the FDA said in a warning to the public.
“We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.”
The FDA noted that results of one clinical trial showed that over the course of a year 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.
In addition to seeking the free Invokana legal consultations offered through Injuryhelpdesk.com it is very important that Invokana patients notify their health care professionals immediately if new pain or tenderness, sores or ulcers, or infections develop in legs or feet.
“Talk to your health care professional if you have questions or concerns,” the FDA warns. “Do not stop taking your diabetes medicine without first talking to your health care professional.
Invokana, a product of the pharmaceutical giant Johnson & Johnson, targets diabetes 2 patients, and was first in the latest class of diabetes drugs called SGLT2 inhibitors.
The Invokana amputations and kidney failures form the basis of the thousands of Invokana lawsuits that have been filed so far and legal experts expect many more to be filed, including those filed by lawyers through references from Injuryhelpdesk.com .
According to court filings so far, the allegations against Johnson & Johnson in Invokana lawsuits include:
- The company failed to thoroughly research the amputation and kidney failure side effects of the medication.
- The medication is defective and a danger to the health of type 2 diabetes patients.
- The company was aware of these dangerous side effects and hid them from government regulators and the public.
- The company was negligent in its manufacturing of the drug.
- The company falsely marketed Invokana as safe.
Invokana has been a giant source of income for Johnson & Johnson. according to Forbes magazine Invokana’s revenue jumped from $586 million in 2014 to $1.31 billion in 2015 and added another $100 million in incremental sales in 2016.
The FDA also instructed health care professionals to consider factors that may predispose patients to the need for amputations before prescribing Invokana.
These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, the FDA said.
The agency said that if untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Invokana is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors and lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.
The FDA said final results from two clinical trials – 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, which is an inactive treatment. The CANVAS trial showed that over a year’s time, the risk of amputation for patients in the trial were equivalent to:
Invokana lawsuits are now being consolidated into what may become a class action status and there may be time limits involved to preserve the legal rights of Invokana victims.
For those victims seeking information about their Invokana legal rights, organizations such as Injuryhelpdesk.com are available to provide quick references to a nationwide network of attorneys who specialize in such cases and have successfully filed related claims and lawsuits.