Invokana Diabetes Drug Increases Risk of Leg Amputations, FDA Says
Since its release into the market for the treatment of diabetes, Invokana has been linked to a number of frightening health risks. The drug was created by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, to maintain blood sugar levels for those with Type II diabetes. However, numerous lawsuits have since been filed against the creators of Invokana because of the dangerous side effects, leading to kidney failure, leg amputations, and even death.
Previous Health Risks
In 2015 the FDA issued a warning, linking Ivvokana to serious side effects, including ketoacidosis. Highly dangerous, and even deadly, ketoacidosis is the result of buildup of acid in the blood, caused by the body’s inability to regulate blood sugar. The FDA also warned that the drug could cause serious urinary tract infections, kidney damage and failure, pancreatitis, cardiovascular failure, low blood sugar, yeast infections, and decreased bone mineral density, which can lead to fractures. After the announcement, numerous lawsuits were filed across the U.S., including 73 cases of ketoacidosis and 19 cases of severe blood and kidney infections.
Medical Studies for Amputation Threats
Shortly thereafter, the European Medicines Agency started an investigation into Invokana, finding an increased risk of limb amputation. The FDA then mirrored the European examination with one of their own. The study that yielded this new information involved two clinical trials, both of which concluded that leg and food amputations were twice as likely to occur in patients treated with Invokana. The most common amputations were of the toe and middle of the foot, though some amputations of the leg, below and above the knee, were also reported. A few patients had to have both legs amputated.
On May 16, 2017, the FDA made their official announcement warning that Invokana causes an increased risk of leg and foot amputations. The boxed warning, the FDA declares, will soon be revised, to add this new warning to the growing list of negative side effects. If patients have a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, they are at a higher risk for health problems that could lead to amputations.
These new hazards have led the FDA to issue a “black box” warning, (their highest precaution), to encourage physicians and patients to watch for any serious side effects. The terrible irony of the situation is that Invokana is now causing the problems it was created to prevent, such as drastically low or high blood sugar levels.
Patients taking the drug should be on the lookout for the following symptoms in the legs and feet, as they may be the initial signs leading to amputation:
- Pain or tenderness
If you experience any negative side effects while taking Invokana, contact your doctor immediately or visit your nearest medical facility for treatment.
Get Legal Help
Our legal team at Schneider Hammers is currently accepting cases for those harmed by the dangerous drug, Invokana. We are investigating the fault of this drug and compiling legal evidence to better protect the victims harmed by this hazardous medication. Our firm’s ample resources and legal skills regarding personal injury cases better equip us to represent the injured to fight for their rights.
To read the warning released by the Food and Drug Administration (FDA), click here.
To get started building your personal injury case today, and contact Schneider Hammers in Atlanta, Georgia to schedule a confidential free consultation.