FDA Black Box Warning Singles Out Invokana Risks
While there are other drugs in the same class as Invokana, such as Empagliflozin and Dapagliflozin, the FDA warning has not been extended to these. The singling out of Invokana was based upon the results of the CANVAS study which did not support the increased risk of amputation for the users of other drugs in this class (86% of the reported amputations had been using Invokana/Canagliflozin).
Europe Follows in Warning Against Invokana Safety and Risks
The FDA was not alone in issuing safety alerts against the drug. The European Medicines Agency (EMA) has also taken a stand in issuing Invokana amputation warnings.
The EMA is a similar regulatory agency to the FDA, with a mission to evaluate drugs and medicines, to study their benefits and dangers and ensure access to safe, beneficial medicines to the community of the European Union. In early 2016, the EMA announced its investigation in the risk of Canaglifozin-related lower limb amputation. Then in 2017, the EMA issued a warning in regard to the increased amputation risk factor associated with the use of this drug and stated that this warning should accompany all prescribing information.
In the UK it is the MHRA (Medicines and Healthcare Products Regulatory Agency) that is tasked with the regulation of drugs, medicines and devices for use in the UK. The MHRA has also added an advice on the increased risk of lower limb amputation among Invokana users in its drug safety updates.
What Is Invokana? What Is a SGLT-2 Inhibitor?
Invokana is a diabetes drug. In simple terms, a Type II diabetic cannot process the glucose in their blood stream effectively. One of the key processes in a healthy individual that regulates sugar levels in the body, takes place in the kidneys. This process involves what you might call “gatekeepers” or a Sodium-Glucose-Cotransporter (Shortened to SGLT-2). One action of SGLT-2 is to transport glucose back into the bloodstream and the body. In fact, almost all the sugar/glucose that filters through the kidneys is reabsorbed into the blood stream by a SGLT-2.
Invokana, or Canagliflozin, is a type of drug called a SGLT-2 Inhibitor. How does Invokana work? Very simply, the Invokana diabetes process restricts the action of sugar being reabsorbed into the blood from the kidneys. Instead, the sugar passes into the urine and out of the blood. The result is that blood sugar levels drop and, along with diet and exercise, the SGLT-2 Inhibitors can help to control Type II Diabetes.
What Are the Side Effects of Invokana and SGLT-2 Inhibitors?
According to the FDA website, there are multiple Invokana side effects beyond the risk of amputation. As listed these include:
- A decrease in blood pressure
- Invokana ketoacidosis, a potentially life-threatening condition where acid builds up in the blood
- Kidney complications and issues
- Increased levels of potassium in the blood, hyperkalemia, which can cause serious heart-rate disruptions
- Painful bladder and urinary tract infections
- Hypoglycemia, or low blood sugar, when taken with other diabetes medications
- Yeast infections, genital mycotic infections, with a higher rate of occurrence in female patients
- Increased risk of fractures and bone breaks
- Raised cholesterol, both LDL and HDL
The most common Invokana side effects are the lowering of blood sugar, vaginal thrush (yeast) type infections in women, candidal balanitis (inflammation of the penis due to yeast infections) as well as constipation, increased passage of urine—particularly at night and feeling thirsty or sick.
Update on the Invokana Lawsuits
To date, in the U.S., there have been over 1,000 lawsuits filed against Johnson & Johnson and their subsidiary Janssen Pharmaceuticals, the manufacturer of Invokana, regarding the drug’s dangerous side effects. The number is growing across the country, with the majority of cases being filed in federal courts.
In September of 2015, an Invokana class action suit was filed in Nova Scotia, Canada against Janssen Pharmaceuticals. The suit claims that Invokana poses severe risks, even death, as the result of kidney failure. Furthermore, they claim that this drug has led to over $1 billion in damage to Invokana users in Canada. The class action suit seeks to have the drug removed from the market due to its risks and that the manufacturer, Janssen, failed to adequately test the drug for safety and that they were negligent in warning patients.
Currently, none of these have come to trial. However, in May of 2017, the US District Court for New Jersey organized over 200 cases into multidistrict litigation as MDL 2750. This bellwether or MDL case has moved forward and is scheduled for a trial date in September 2018. This process can then efficiently pave the road for future litigation and compensation. An MDL process is increasingly the path followed to handle medical device and drug defects.
While we have yet to see any completed Invokana lawsuits, there is ample reason for plaintiffs to discover more about your rights and potential case as soon as possible. As is often the case in these lawsuits, the pharmaceutical companies may seek to settle such cases out-of-court and to avoid trial. To protect your rights, you should be legally represented.
Multi-Billion Dollar Settlement for Diabetes Drug, Actos
Individuals that have suffered as the result of taking Invokana for diabetes have good reason to hope for compensation based upon recent settlements involving similar drugs. For example, in 2015, a Japanese drug manufacturer settled lawsuits connected to their Type II diabetes drug, Actos, in the amount of $2.4 billion. This drug was linked to cases of bladder cancer.
In fact, one U.S. individual was awarded a multibillion-dollar settlement related to Actos bladder cancer pain and suffering. The settlement was later reduced to $38 million but still represents a very sizeable compensation.
Finding an Invokana Amputation Lawyer
At Baum Hedlund, our personal injury attorneys are here to help those that have suffered physical, emotional and financial loss as the result of using pharmaceuticals like Invokana. We know that your interests are best served by maximizing the compensation that you could receive from an Invokana lawsuit, as well as delivering a strong message to pharmaceutical companies such as Johnson & Johnson.
Keeping us all safe and protected against unnecessary pain and suffering is best achieved by insisting that consumers are fully informed of the dangers and risks involved with taking drug products. Misinformation and the failure to inform cannot be tolerated and these cases serve to not only bring restitution to the individual, but to curb these corporate abuses.
How to Join the Invokana Amputation and Ketoacidosis Lawsuit?
Baum Hedlund is here to look to your rights and to help you to better understand your potential case and your options. We offer free no-obligation Invokana amputation lawsuit consultations.
Our mission is to protect your rights and we are here to help. Please fill out our contact form or contact us directly by calling toll-free (800) 827-0087.
Baum Hedlund is proud to be working with the top law firms in the country, leading the Invokana amputation litigation.