Pittsburgh Invokana Lawsuit
Patients with type 2 diabetes who are taking the drug Invokana (canagliflozin) should be particularly cautious about symptoms like nausea and vomiting, difficulty breathing, abdominal pain, confusion, and unusual fatigue. These may signal a dangerous condition called diabetic ketoacidosis (DKA), which can lead to hospitalization, coma, and even death. If you or a family member have suffered as a result of taking the medication Invokana, you may be entitled to recover compensation for you or your loved one’s physical and emotional suffering. Contact an experienced Invokana lawyer to learn whether you are eligible to file an Invokana lawsuit and recover the compensation.
The FDA recently issued a safety communication alerting both patients and doctors to the risk of DKA, and also required manufacturer Janssen Pharmaceuticals and parent company Johnson & Johnson (J&J) to add new warnings to the product labels. They’ve also required the most serious boxed warning to alert users to the risk for leg and foot amputations.
Pittsburgh residents who have taken Invokana and suffered DKA or other serious side effects requiring hospitalization are advised to speak to the Invokana attorneys at Chaffin Luhana immediately. Evidence shows that manufacturers were aware of certain risks associated with the drug that they failed to adequately communicate to the public. If your life has been turned upside down by this medication, please contact us today for a free initial consultation.
The FDA Warns About Invokana Ketoacidosis
Invokana has been on the market since March 2013, when the FDA approved it for the treatment of type 2 diabetes. It is one of a new class of drugs called “sodium-glucose co-transporter 2 (SGLT2)” inhibitors. These drugs work to lower blood sugar levels by actually inhibiting the kidneys from absorbing glucose, which causes more of it to be flushed out of the body through urine. Other medications in the same class include Farxiga, Glyxambi, Jardiance, and Xigduo XR.
On May 15, 2015, the FDA warned that these drugs could increase the risk of DKA, a condition in which the body produces too many “ketones.” Ketones are blood acids produced when the body burns fat instead of glucose for fuel. The condition is often a sign that there is not enough insulin for the body to draw adequate glucose from the blood into the cells, so it turns to fat instead. This is only a problem if high levels of ketones accumulate in the blood—which causes it to become too acidic.
Patients with type 1 diabetes are usually the ones most at risk for DKA, because they often lack sufficient insulin levels. Those with type 2 diabetes typically have enough insulin, but their bodies can’t use it like they should.
This explains why the FDA became alarmed when they received 20 reports of patients with type 2 diabetes suffering DKA. It didn’t make sense. These 20 patients were also taking SGLT2 inhibitors.
Why would the drug lead to this dangerous condition?
Scientists believe it has something to do with how these drugs interrupt normal kidney function. It is the kidneys, along with the respiratory system, that usually keeps the body’s pH level in balance. They are the organs that flush the ketones out. If there is a buildup of ketones in the body, it must be that the kidneys aren’t able to do their job.
Symptoms of DKA include those mentioned above: difficulty breathing, nausea, and vomiting, abdominal pain, etc. Other early signs that DKA is occurring may include dry mouth and thirst, frequent urination, high blood glucose levels, and high blood ketone levels.
DKA can lead to serious complications, including:
- Cerebral edema
After completing their safety review, the FDA issued another drug safety communication on December 4, 2015, stating that they were requiring the manufacturers to add warnings about DKA to the product labels. They noted that between March 2013 and May 2015, they identified 73 cases of the condition in patients type 1 or type 2 diabetes treated with Invokana and similar SGLT2 inhibitors, and added there were likely additional cases that weren’t reported.
Patients suffering from Invokana-related DKA often have blood glucose levels below those typically expected for the condition. The FDA suggested that patients watch for symptoms like nausea and vomiting, tiredness, abdominal pain, and trouble breathing. They added that patients with these symptoms should stop taking the drug immediately and seek medical attention.
Invokana Increases Risk of Urinary Tract Infections and Other Side Effects
DKA is only one of many potential side effects associated with Invokana. Within just a year of its release, the medication was linked with 457 reports of problems. According to the Institute for Safe Medication Practices (ISMP) QuarterWatch report, these included:
- Kidney failure or impairment
- Dehydration and fluid imbalances
- Kidney stones
- Urinary tract infections
- Allergic reactions
- Abnormal or other weight loss
In fact, as part of the December 2015 FDA drug safety communication, the FDA also required the manufacturers to add warnings concerning the risk for serious urinary tract infections.
The authors of the ISMP report expressed their doubts about Invokana, stating: “Also, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.”
There is no question that Janssen was aware of at least some of these potential complications. In the clinical trials submitted to the FDA to garner approval for the drug, 14 percent of women and nearly 4 percent of men developed fungal infections at rates 4-6 times those in patients taking other diabetes drugs. Researchers believe that the excess glucose in the urine increases risk for these types of infections since the glucose provides a food source for the microorganisms.
A 2013 article in Forbes magazine addressed this concern. Author Matthew Herper quoted Lawrence Biegelson of Wells Fargo Securities, who argued that Invokana may be tough to market: “[W]e have modest expectations for Invokana and the SGLT-2 class because the drug and class are associated with a relatively high rate of genital infections which will limit uptake in our view.”
Some doctors are also concerned about the long-term effects of the drugs on the kidneys. The FDA noted in their review that the long-term consequences of canagliflozin on the kidneys were unknown and that it was “prudent to assume” that the slightly reduced kidney function seen in the studies “places patients at increased risk for clinically significant episodes of acute kidney injury.”
Invokana May Increase Risk of Cardiovascular Problems
During the process of FDA review of the studies involving Invokana, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, expressed his concerns about the drug and its potential to increase the risk of heart attacks and other cardiovascular problems.
The doctor testified in front of an FDA advisory committee, in which he urged the panel to think twice before approving Invokana for use in diabetics. The drug could increase the risk of low blood pressure symptoms and cardiac events, he stated, in addition to genital and urinary infections.
“The fact that the drug works by a uniquely new mechanism to lower blood sugar has not spared of a whole set of unique new risks,” he said. “The FDA has previously made too many mistakes in approving drugs, including those for diabetes, with no unique clinical benefits and unique risks. The agency shouldn’t approve this one.”
In the end, the panel voted 10 to 5 to approve the drug, as clinical trials showed it improved blood sugar levels, but even some who voted “yes” expressed concerns about the potentially serious side effects, including elevated stroke risk, an increased risk of heart attack and other cardiovascular problems in the first 30 days of treatment, and an increased risk of higher LDL “bad” cholesterol levels.
With respect to the trial cited by the FDA reviewer, the FDA concluded that “any imbalance in results during the first 30 days or the trial” in question “may be attributable to chance or may have been caused by an early increase in the risk of MACE [major adverse cardiovascular events]-plus associated with canagliflozin among subjects with high background cardiovascular risk.” The FDA went on to note that “There was no evidence of an increased risk of MACE-plus associated with canagliflozin after 30 days” in the trial.
Invokana Linked to Increased Risk of Amputations
The results of two large clinical trials also showed that Invokana could significantly increase the risk of leg and foot amputations. Final results indicated that patients taking the Invokana suffered from amputations about twice as often as patients treated with an (inactive) placebo.
The most common amputations were those of the toe and the middle of the foot, though amputations of the leg also occurred. Some patients had to go through more than one amputation, in some instances involving both limbs.
On May 16, 2017, the FDA released another drug safety communication alerting doctors and patients to the risk of amputations. They advised doctors to consider factors that may put patients at a higher risk, including peripheral vascular disease, neuropathy, prior amputation, and diabetic foot ulcers.
Patients taking Invokana were warned to report symptoms including sores or ulcers, infections, and new pain or tenderness in the legs and feet to their doctors immediately.
Types of Injuries that May Affect Pittsburgh Patients Taking Invokana
In addition to the effects listed above, some studies have also indicated that drugs like Invokana may fall far short of their promises. A 2014 study, for instance, reported that dapagliflozin, another SGLT2 inhibitor, increased glucose excretion in the urine and lowered fasting blood sugar levels, but also increased the body’s production of glucose and increased glucagon levels. (Glucagon is a hormone that raises blood sugar.) These increases offset about half the amount of blood sugar flushed away because of the drug.
A second study published a month earlier showed similar results, leading researchers to conclude that the body was compensating for the drug’s activity by releasing more glucose into the bloodstream.
Altogether, the types of injuries that may result from taking Invokana include:
- allergic reactions
- yeast infections
- urinary tract infections
- kidney stones
- decreased kidney function/kidney failure
- increased LDL “bad” cholesterol
- heart attack
- dehydration and fluid imbalances
- foot and leg amputations
Your Pittsburgh Invokana Lawyer Can Help
If you or a loved one suffered ketoacidosis, cardiovascular problems, amputation, urinary tract infections, or other serious injuries after taking Invokana, the Pittsburgh attorneys at Chaffin Luhana LLP can help you or your loved one file an Invokana lawsuit. We understand that manufacturers like Janssen and Bayer are responsible for making sure their products are safe before releasing them on the market. They are also responsible for making sure doctors and patients are well aware of the risks before prescribing or taking their drugs.
Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, western Pennsylvania, and Eastern Ohio, and will give you an initial consultation for free. Contact us today.