Invokana (canagliflozin), is a medication to help people with type-2 diabetes control their blood-sugar levels. When it was approved by the FDA in 2013, Invokana was the first drug in a new class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs help prevent hyperglycemia (high blood-sugar levels) by helping the patient’s kidneys remove excess sugar from the body through the urine.
Following 9 clinical trials involving over 10,000 patients, improvement was seen in blood sugar control and blood sugar levels and so the FDA approved this particular class of drug. The FDA approval then allowed the drug companies, including the manufacturer of Invokana, to launch aggressive marketing campaigns aimed at those physicians treating type 2 diabetes.
It is estimated that 29 million Americans have diabetes. Of these, over 90% have type 2 diabetes. The market for any new drug claiming to control this widespread disease is obvious and it was rushed onto the market. It turned out to be a windfall for Johnson & Johnson earning over $250 million in the first three months of 2015.
Invokana holds the number one position in sales of this drug but it is now becoming evident that this drug causes a life threatening condition in some patients. The Invokana lawsuit is a result of damages to patients who were not warned of the risks of using Invokana which so far involve developing acidosis or serious urinary tract infections.
Problems with Invokana
In May 2015, the FDA warned that these treatments may put patients at risk for a serious health condition known as ketoacidosis, which may cause diabetic comas or death. Ketoacidosis is a condition where the blood becomes too acidic due to the buildup of ketones. Ketones are a byproduct of burning fat for cellular energy rather than using blood sugar (glucose). In a non diabetic person, producing ketones due to diet and exercise is a great way to lose weight. However in a person with diabetes, a buildup of ketones can quickly be life threatening.
Throughout the United States, some people who have used Invokana to control their blood sugar levels have developed diabetic ketoacidosis or DKA. While there is no official Invokana recall yet, the medical harm caused by Invokana is documented and patients affected are owed financial compensation for their pain and suffering.
Increased Risk of Genital Infections and Fournier’s Gangrene
The FDA has received several reports of Fournier’s Gangrene or necrotizing fasciitis cases linked to popular sodium-glucose cotransporter-2 (SGLT2) Inhibitors including Invokana, Jardiance, Farxiga, and Streglatro.
Fournier’s gangrene is a rare, at times life-threatening, bacterial infection that affects the genital area. The bacteria enter the body through a cut and can spread quickly to affect the scrotum (including the testicles), penis, or perineum. For women, the perineum is the area between the anus and vulva. For men, the perineum is between the scrotum and anus. This type of necrotizing fasciitis, also known as flesh-eating bacteria, not only infects the genital tissue, causing it to die, but can also spread and stretch to affect the thighs, stomach, and chest.
Over a five-year period, the FDA identified 12 cases of Fournier’s gangrene linked to SGLT2 inhibitors. Reports show seven men and five women have contracted the genital infection and all 12 patients had to be hospitalized for surgical procedures to remove infected tissue. Several required multiple surgeries, leading to serious disfigurement of their genitalia and genital area. One patient died due to the infection.
As stated above, SGLT2 inhibitors, such as Invokana, were first approved in 2013 and are prescribed to lower blood sugar in adults with type-2 diabetes. FDA-approved SGLT2 inhibitors that are linked to Fournier’s Gangrene Johnson & Johnson’s Invokana, Eli Lilly & Co’s Jardiance, and medications from Bristol-Myers Squibb, Astra Zeneca Plc, Merck & Co and Pfizer Inc.
If you or a loved one has developed a genital infection such as Fournier Gangrene while taking Invokana or other SGLT2 inhibitors, Meyers & Flowers can help you explore your legal options.
Increased Risk of Amputations
Two recent clinical trials (May 18, 2016 ) were conducted with the medication Invokana. As mentioned earlier, this drug is used to lower the blood sugar levels in your system by making the kidneys remove sugar from the body via urine. Through these trials it was found that patients using a canagliflozin such as Invokana vs the patients using a placebo with an in inactive treatment agent, were twice as likely to need a form of amputation. The amputations of the toe and middle of the foot were some of the most common; however, amputations involving the leg, both below and above the knee, had also occurred. Some patients also had more than one amputation, involving both of the limbs.
The FDA has recently concluded that type 2 diabetes medicine canaglifozin (such as Invokana, Invokamet XR and Invokamet) causes an increased risk of foot and leg amputations. Because of this, these medications are now required to display this increased risk in a prominent boxed warning label on their bottles.
If you or a loved one have been affected by the mislabeling and harm of this medication, our Chicago Invokana lawyers are here to help. Contact us today so we can help get you the compensation and justice you deserve.
FDA issues additional warnings to diabetics taking Invokana, Inokamet
The Food and Drug Administration (FDA) has recently strengthened its warning for diabetics taking Invokana, Invokamet (canagliflozin).
According to a June 14, 2016, FDA statement, from March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases* of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use.
This new warning adds to previous warnings from the FDA. In the past, the government agency stated canagliflozin, a sodium-glucose cotransporter-2 (SGLT2) drug, may cause an increased the risk of developing ketoacidosis. For patients taking Invokana this can result in the dangerous, at times, life-threatening condition, occurring as the body produces unnaturally high levels of blood acids. Ketoacidosis may then lead to hospitalizations, kidney damage, diabetic coma or even death.
Meyers & Flowers continues to fight for the rights of Invokana patients who have experienced ketoacidosis and their families.
Invokana investigations are ongoing
In a drug safety announcement, the FDA said it was investigating reports that certain type 2 diabetes drugs caused a serious medical condition known as ketoacidosis. According to the American Diabetes Association, ketoacidosis – also known as acidosis or diabetic ketoacidosis (DKA) – is a condition that causes the body to produce excessive levels of blood acids, or ketones, and can lead to diabetic coma and even death.
The FDA’s investigation reportedly came after the agency reviewed 20 adverse event reports from patients who were seriously injured or hospitalized for the condition after taking type 2 diabetes drugs, including Invokana and Invokamet. These drugs belong to a class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, which have been FDA approved to lower blood sugar in adults with type 2 diabetes. This is part of the reason we launched an Invokana lawsuit.
Meyers & Flowers attorneys are dedicated to getting meaningful compensation for people who have been injured by medical devices and drugs. We don’t allow our clients to be intimidated by the damage response team of lawyers who defend the drug companies when their products harm the public. Our clients are protected from the details so they can concentrate on recovering from the damage caused by Invokana and Invokamet.
An Invokana lawsuit will seek to obtain financial compensation for hospital costs, rehabilitation, medication, pain and suffering and in some cases mental suffering. Being injured by a drug can have effects that reach far into the future. If you have experienced harm caused by Invokana our experienced team of medical device injury attorneys will thoroughly outline any current or future damages suffered as a result of using Invokana whether or not it is subject of an FDA recall.
In the FDA’s announcement, the agency warned patients that they should seek immediate medical attention if they experience any symptoms of ketoacidosis, including:
- Difficulty breathing
- Abdominal pain
- Unusual fatigue or sleepiness
The Food and Drug Administration’s recent safety review of Invokana resulted in new warnings for diabetics taking the medication. Meyers & Flowers wants you to know what the new warnings mean if you or a loved one have taken Invokana?
How we can help
At the law offices of Meyers & Flowers in Chicago, we have the expertise and experience to pursue litigation against large medical firms. Our long record of excellence includes million-dollar awards on behalf of clients harmed by medical device failure. This is why we should be your Invokana Lawyer.
If you have been prescribed Invokana and are seeking legal recourse, we can help. We also can help if you have a family member that passed away as a result of taking Invokana. Your first step is a free consultation with our law professionals to discover if you have a case. It costs nothing to find out your options, and you pay no fees until we win your case. Please call us today to find out more.