The story behind Invokana is very similar to Januvia, Accutane, Byetta, and other dangerous drugs.
Millions of Americans suffer from Type 2 Diabetes. As the disease spread in the early 2000s, anti-diabetes drugs were at a premium. So, when Invokana (Canagliflozin) became available in 2013, many people hailed it as a miracle drug. Janssen Pharmaceuticals Johnson & Johnson division, aggressively marketed Invokana as a cutting-edge way to control diabetes and lose weight. Before long, the company had sold billions of dollars worth of Invokana worldwide.
But along the way, it appears that the company took dangerous shortcuts. In 2015, the Food and Drug Administration warned of possible serious complications, including diabetic ketoacidosis, bone fractures, and urinary tract infections. Later warnings included possible amputations and, in August 2018, Fournier’s Gangrene. As a result, Invokana sales have tumbled almost 30 percent, and Janssen faces some 1,100 liability lawsuits.
These lawsuits seek compensation for actual losses, as well as punitive damages. The complex legal and factual issues involved demand highly-experienced representation. The professional team at Napoli Law has the credentials to handle these cases. We represent victims of dangerous drugs on a nationwide basis, so we have the resources that these cases require. More importantly, the big pharmaceutical companies do not scare Paul J. Napoli and his colleagues. They will not back down. Instead, they will fight to the end to get the compensation and justice you deserve.
Is Invokana a Dangerous Drug?
Doctors were excited about Invokana because it inhibited subtype 2 sodium-glucose transport proteins. After several years of success in Europe, Canagliflozin was the first FDA-approved SGLT2 inhibitor.
SGLT2 proteins reabsorb about 90 percent of the body’s glucose. Invokana blocks these transporters, enabling patients to pass over 100 grams of blood sugar per day through their urine. That means the excess blood sugar never enters the kidneys.
As a bonus, SGLT2 inhibitors, a class which also includes Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Invokamet, Invokamet XR, Farxiga, Synjardy XR, Steglatro, Segluromet and Steglujan, carry a very low risk of hypoglycemia (low blood sugar).
Issues with the drug approval system magnified problems with the drug itself. It costs an average of $2.5 billion just to bring a new drug to market. At the same time, Congress has slashed the length of drug patents. So, companies like Janssen must sell a lot of product in a short amount of time to show a healthy profit. They aggressively market these drugs and sometimes bury negative information.
The Infuse Bone Graft is a good example of an aggressive marketing campaign that went off the rails. To boost sales, Medtronic encouraged doctors to use the drug in experimental ways. The company sponsored lavish retreats for doctors and may have even falsified safety information.
As for Invokana, Janssen was not able to bury negative information for long. It soon came to light, but not before this dangerous drug seriously injured thousands of patients.
Invokana Side Effects, Round One
At the onset, Janssen acknowledged that Canagliflozin was risky. However, the company insisted that side effects were generally mild to moderate. They included things like thirst, high cholesterol levels, low blood pressure, and increased urination.
But the company did not tell patients the whole story. It put profits before people. In 2015, the FDA issued warnings for:
- Diabetic Ketoacidosis: Invokana does nothing to correct insulin imbalances in the body. When insulin production is low, the body produces highly-acidic ketones, leading to DKA. This disease often causes swelling of the brain, along with dangerously-low potassium and blood sugar levels. According to the FDA, Invokana-induced DKA quite often requires extensive hospital stays and is sometimes fatal.
- Bone Fractures: Many anti-diabetes medications have been linked to osteoporosis and weak bones. With regard to Invokana, that link was even stronger. Despite this evidence, the FDA approved Invokana. Two years later, it ordered Janssen to update the label and include the risk of serious fractures.
Other 2015 changes included an enhanced warning about urinary tract infections. It seems that the UTI risk was much greater, and much more serious, that Janssen first acknowledged.
Invokana Side Effects, Round 2
The FDA hardly ever recalls drugs. Recalls put the agency in a very bad position. No one, including bureaucrats at the FDA, likes to admit that they made mistakes. So, Janssen continued to sell Invokana and continued to insist that the drug was safe.
This denial and stay-the-course strategy worked, at least for a while. But shortly thereafter, in 2017 and 2018, new and even more sinister dangers became apparent, including:
- Amputation: Diabetes is one of the leading causes of amputations in the United States, especially in the lower extremities. Some doctor speculate that the SGLT2 inhibitors cause blood to pool in the feet and toes. That significantly increases the risk of amputation. This risk is especially troubling because Invokana is supposed to ease the effects of diabetes instead of making them worse.
- Fournier’s Gangrene: When Invokana first hit the shelves, Janssen admitted risk of bacterial genital infections. But the actual risk is much higher than the company admitted. Necrotizing fasciitis usually begins in the perineum (area between the genitals and anus) because of a cut. It is almost always either extremely serious or fatal. Before Invokana, thirty years of anti-diabetes drugs produced six of these cases. After using Invokana for just three months, twelve people developed Fournier’s Gangrene. All of them required emergency long-term hospitalization.
Legally, victims have two basic options to get the compensation they deserve.
Manufacturers are strictly liable for damages if the products they sell are unsafe. Victims in these cases need only prove cause. If there is a link between Invokana and your serious illness, Janssen may be legally responsible.
Negligence is another common theory. It is all too obvious that Janssen knew about Invokana’s risks yet sold the drug anyway. Such behavior clearly demonstrates a lack of care. In New York, all pharmaceutical negligence and strict liability cases are a bit easier to win. New York courts have victim-friendly rules on expert witnesses and other procedural matters.
Invokana causes serious side effects and Janssen knew about them before it began selling this dangerous drug. For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. Attorneys can connect victims with doctors, even if they have no money or insurance.