Products Liability
The Food and Drug Administration (FDA) expressed concern about a particular group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been relatively successful when treating Type 2 diabetes, they have produced side effects. Specifically, users of drugs such as Invokana are now reporting high levels of blood acid, the results of which have landed some users in the ER.
The result has been an MDL class action style lawsuit in the Invokana cases, with over 230 lawsuits as of May 2017.
The first trial in these cases was expected in September 2018. In April 2017, the MDL panel also approved a Farxiga MDL. In October 2018, Johnson & Johnson agreed to pay settlement compensation to most of the 1,000 Invokana lawsuits filed in the MDL class action. There are only 85 cases still “active” in the MDL in January 2023.
SGLT2 Inhibitors
Invokana and Farxiga fall under an umbrella of a relatively new class of medications referred to as SGLT2 Inhibitors. SGLT2 inhibitors are a class of medications that are used for the treatment of type 2 diabetes. These drugs block the reabsorption of glucose in the kidneys. This leads to an increase in glucose excretion in the urine which, in turn, leads to a decrease in blood glucose levels and improved glycemic control.
The FDA considers this a fairly novel group of drugs and has only approved two medications within the class: Canagliflozin (Invokana) and Dapagliflozin (Farxiga). Both drugs are intended to treat Type 2 Diabetes by inhibiting the glucose absorbed into the bloodstream. So these medications lower blood-sugar levels via the kidneys. Excess sugar is excreted in the user’s urine.
Someone with Type 2 Diabetes typically produces and transports more glucose in their blood than a person who does not have diabetes. This prevents glucose from being excreted from the body as quickly as it should, resulting in hyperglycemia (high blood sugar levels). SGLT2 Inhibitors work to ensure that the proper amount of glucose is excreted from the body, thus stabilizing blood sugar levels. Invokana was one of the first SGLT2 inhibitors to be approved by the FDA in March of 2013, with Farxiga receiving approval approximately one year later. As with many diabetes treatments, diet and exercise are recommended to reap the full benefits of the drug.
Invokana Side Effects
After the drug became more widespread, some users of Invokana began to experience ketoacidosis. This condition is essentially a buildup of acid in the blood, which can lead to severe complications. Generally, people with Type 1 Diabetes are at the highest risk of ketoacidosis because their bodies do not produce insulin. Further, the body uses fat cells instead of glucose for energy to compensate for the lack of insulin. This process produces ketones, which also build up when the body is sick, stressed, or if one misses a meal. In the end, an excess of ketones can disrupt the body’s entire chemical balance, leading to symptoms such as vomiting, nausea, confusion, fatigue, abdominal pain, and difficulty breathing.
On May 5, 2015, the FDA officially issued a warning regarding the potentially fatal side effects of SGLT2 Inhibitors. The warning noted that around 20 cases of acidosis or ketoacidosis were identified by the FDA, all of which required the patients to seek emergency medical attention. While no deaths have been reported from SGLT2 Inhibitors, untreated ketoacidosis can lead to coma and even death. This is why it is so crucial for people on drugs, such as Invokana and Farxiga go to the emergency room if they experience any of the side effects listed above.
The FDA isn’t the only group concerned about this drug either. The Institute for Safe Medication Practices helped shed some light on several side effects associated with Invokana. Most of them involved potential kidney issues such as kidney failure and impairment; severe dehydration; kidney stones; and urinary tract infections. But severe allergic reactions were also reported. The utility of this drug is starting to be questioned, especially considering that clinical trials showed that people on the pill have a higher risk of developing a fungal infection. Keep in mind this does not even consider the long-term animal tests that showed a correlation between the medication in Invokana and certain types of cancer.
Do you know how else is taking the risks of Invokana more seriously? Health Canada. This Canadian version of the FDA in September 2017 forced Janssen to send a “Dear Doctor” notification of risk letter to prescribing doctors of Invokana about the possible risk of lower limb amputations.
Invokana Lawsuits
Just because a drug causes harmful side effects does not mean that everyone affected by those side effects has a legal claim against the manufacturer. Typically, a drug manufacturer is sued because they failed to warn or tried to conceal the hidden dangers behind their drug. In this instance, lawyers are pursuing claims against the manufacturer of Invokana, claiming that they failed to warn about the risks of ketoacidosis.