FDA Issues Warning for Invokana Due to Drug’s Doubling Risk of Amputation
People across the nation who suffer from Type 2 Diabetes will likely receive a prescription from their treating physician for Invokana, Invokamet, or Invokamet XR to manage the disease. All of these drugs are SGLT2 inhibitors. In other words, they work to lower a patient’;s blood sugars. In fact, Invokana was the first prescription drug of a new treatment using SGLT2 inhibitors for patients with Type 2 diabetes. SGLT2 inhibitors force the kidneys to release more sugar into the urine in order to lower a patient’;s blood sugar levels.
The U.S. Food & Drug Administration first approved Invokana in March of 2013. A clinical study revealed that patients on SGLT2 inhibitors were at double the risk of developing ketoacidosis. Ketoacidosis is a life-threatening medical condition that happens when a patient’;s blood becomes too acidic. In fact, after more than 70 cases of the condition were reported to the FDA, the agency issued safety alerts on the drugs. Some patients taking Invokana suffered more than one amputation; a percentage of them required amputations in both limbs.
If you have been injured by Invokana, don’t hesitate to contact Farah & Farah immediately for assistance. We have decades of experience helping clients who have been hurt by dangerous pharmaceuticals and our aggressive legal team will help ensure you are able to recover the compensation that you deserve.
New FDA Safety Alerts in 2017
In May of 2017, two independent studies conducted by Johnson & Johnson’;s Janssen Pharmaceuticals revealed the risk of amputations were as much as double for those patients taking Invokana compared to those who were merely taking a placebo. The results of these studies, named CANVAS and CANVAS-R, were what prompted the FDA to require a black-box label, the most prominent type of warning label, noting the increased risk of amputations on the labels for Invokana, Invokamet, and Invokamet XR. While there are other SGLT2 inhibitors on the market (namely, Farxiga and Jardiance) the high amputation risk seems to only be linked to Invokana. The study’;s authors claim the benefits of the drugs – which include a reduced risk of non-fatal heart attacks and strokes, as well as fatal ones – outweigh the amputation risks. Notably, the issuance of a black-box label warning is the strongest type of warning required by the FDA; it signals physicians and patients that the prescription drug may lead to serious health risks and problems.
Other Medical Risks
The FDA previously required labels to contain warnings that indicate Invokana, Invokamet, and Invokamet XR increase the risk of ketoacidosis, acute kidney injury, kidney failure. The FDA notes patients taking these medications should immediately notify their healthcare provider if they develop new tenderness or pain, infections, or sores or ulcers in the legs or feet. Moreover, health care professionals should consider factors that may predispose a patient with Type 2 Diabetes to the need for amputations. Some factors include peripheral vascular disease, neuropathy, diabetic foot ulcers, or a history of prior amputations.
The FDA also received reports possibly linking these pharmaceutical drugs to a form of acute pancreatitis. While the most common causes of pancreatitis are heavy alcohol consumption or gallbladder stones, some medications can cause it, as well. Pancreatitis happens when the pancreas, which is the organ responsible for creating insulin, suddenly swells up and becomes inflamed. This medical condition is very painful and approximately 10 percent of patients who develop pancreatitis die as a result. The most common symptoms of pancreatitis include rapid pulse, swollen abdomen, nausea, vomiting, and fever. Typically, a patient suffering from pancreatitis requires hospitalization and antibiotics, as well as a liquid diet in order to recuperate from the medical condition.
Research has also linked Invokana to kidney and urinary tract infections that may lead to blood infections.
Pharmaceutical Drugs Litigation
Product liability cases based on pharmaceutical drug-related injuries are quite similar to other product liability claims alleging defects. The difference, however, is that pharmaceutical drug-related injury claims have special features that other product liability claims to not.
Paralleling the three general categories of claims in defective product liability cases, pharmaceutical drug-related claims allege one (or more) of three basic things: defectively manufactured pharmaceutical drugs, improperly marketed pharmaceutical drugs, or inherently dangerous pharmaceutical drugs. Claims alleging manufacturing defects claim the drug was somehow tainted or improperly manufactured. In other words, a mistake occurred at some point between the factory and when the drug was received. Claims alleging dangerous side effects allege that even though the pharmaceutical drug was properly manufactured and was received by the consumer without issue, the drug is inherently dangerous and caused harm. Claims alleging a marketing defect refer to the pharmaceutical drug’s labeling, instructions for use, warnings of side effects or recommendation regarding the product. A pharmaceutical drug litigation claim may involve one or more of these allegations as the basis for the lawsuit.
There are several potential defendants who can be named in a pharmaceutical drug product liability case. Typically everyone in the “chain of distribution” of the pharmaceutical drug should be considered. The “chain of distribution” is the path the pharmaceutical drug takes from manufacturer to the consumer. In short, potential defendants may include the: manufacturer, testing laboratory, pharmaceutical sales representative, physician, hospital or clinic, and pharmacy.
Mass tort lawsuits – which often involve dangerous drugs as well as defective pharmaceutical devices – are filed by individuals. Accordingly, unlike class action lawsuits, even if a defective pharmaceutical drug or device injured thousands of patients, each individually injured person must file his or her own lawsuit in order to receive compensation. A class action is filed by one person or a group of people on behalf of a larger number of people all of whom have suffered a similar physical or financial harm.
Anyone who has been injured by a dangerous pharmaceutical is encouraged to reach out to the legal team at Farah & Farah immediately for help. We will work aggressively on your behalf and put our decades of experience to work for you to help ensure you are able to recover the compensation to which you are rightfully entitled.
How Farah & Farah Can Help with Your Invokana Case
If you have been injured, it’s smart to turn to the team at Farah & Farah. For one, our case results help demonstrate our commitment to serving injured victims in the area; specifically, we have achieved the following over our decades of service:
- $5,000,000 Settlement — Against Hospital Medical Malpractice; Brain Injury sustained while a patient in Emergency Room.
- $3,400,000 Verdict — Truck Accident; Rear end collision by moving truck, results in Herniated Disc and extended pain management to deal with the injuries.
- $3,300,000 Verdict — Maritime Case. Pleasure boat collision with a barge.
- $2,500,000 Settlement — Automobile struck by Pickup Truck.
- $2,500,000 Verdict — Auto Accident; young lady suffered neck injuries and obtained pain management.
- $2,400,000 Verdict — Car Accident, injured driver unable to return to work.
Ultimately, over the course of our work, we have secured over $1 billion for our injured clients, which has helped them move forward with their lives. Don’t put your case in the hands of an inexperienced attorney. Reach out to us today to learn how we can assist you and fight for the compensation that you deserve.
Contact a Florida Lawyer About Your Pharmaceutical Drug Lawsuit
Pharmaceutical companies are tasked with conducting extensive testing prior to releasing a new medication to the market for use by the public. Nonetheless, it can take several years for side effects of these drugs to negatively affect patients taking these pharmaceutical drugs. Contact the knowledgeable Invokana side effect attorneys at Farah & Farah. Our belief is that big pharmaceutical drug companies should be held accountable for putting consumers at risk of illness, injury or even death due to their defective drugs. Protecting the rights of consumers since 1979, these skilled lawyers will fight to obtain the compensation to which you or your loved one is entitled.