Why does Invokana cause Amputations?
Why does Invokana cause Amputations?
FDA SAFETY ALERT: INVOKANA LINKED TO AMPUTATION RISKS
Type-2 diabetes is a terrible disease affecting millions of Americans. There are many drugs that are used to treat type-2 diabetes including the newer class of medications, Invokana and Invokamet.
What is Invokana?
Invokana (canagliflozin) made by Johnson and Johnson and its subsidiary unit Janssen Pharmaceuticals was released in March 2013. Invokana is a new class of diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.
SGLT2 drugs work by affecting normal kidney functions to increase the release of sugar or glucose into the urine. SGLT2 class of drugs includes Invokamet, Jardiance, Farxiga, Xigduo, and others, but Invokana the leader of the pack with blockbuster sales.
Over the last few years, many diabetic patients have switched to Invokana, from other diabetic medications such as Avandia (linked to cardiovascular side effects) and Actos (linked to bladder cancer).
Now serious Invokana side effects have been discovered including Invokana amputation risks, diabetic ketoacidosis, kidney failure, heart attacks and other catastrophic injuries.
Invokana Black Box Amputation Warning
Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.
A black-box warning was issued by the FDA in May of 2017, the warning is the most serious safety alert given by the FDA. The black box warning requires the manufacturers to add information about amputation risks at the top of the labeling surrounded by a thick, black border.
During clinical studies, researchers found that patients given Invokana had double the risk of amputation compared to those taking a placebo or a sugar pill.
FDA Warns Doctors
Health care professionals should, before starting Invokana consider predisposing factors for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving Invokana for the signs and symptoms described above and discontinue Invokana if these complications occur.
FDA Invokana Diabetic Ketoacidosis, Kidney Failure Warnings
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana, highlighting that the medication significantly increases the risk of this potentially deadly condition.
Patients were advised by the FDA to stop taking Invokana and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.
The FDA warning included data about severe urinary tract infections from Invokana use.
In June 2016, the FDA required additional label warnings about the link between Invokana and kidney failure risks, highlighting that the medication may increase the risk of acute kidney injury.
Invokana doubles Amputation risk according to studies
Based on new data from two large clinical trials, the FDA in May 2017 concluded that the type 2 diabetes medicines Invokana, Invokamet, Invokamet XR caused an increased risk of leg and foot amputations.
The FDA is requiring new warnings, including their most prominent Boxed Warning, to be added to the Invokana drug labels to describe this risk.
Invokana Federal Multidistrict Litigation
Since December 2016, all federally-filed Invokana injury lawsuits have been consolidated as part of the federal Invokana multidistrict litigation (MDL), which is centralized before U.S. District Judge Brian Martinotti in the District of New Jersey to coordinate discovery and pretrial proceedings.
How can Dr. Shezad Malik Law Firm help?
If you or someone you know succumbed to an Invokana Ketoacidosis, leg amputations or kidney failure from taking Invokana for the treatment of their type 2 diabetes, please call us for further information at 888-210-9693.
Dr. Shezad Malik Law Firm is investigating and accepting Invokana Ketoacidosis, leg amputations or kidney failure injury cases from Invokana for the treatment of their type 2 diabetes. FREE CASE REVIEW