The Food and Drug Administration (FDA) has recently expressed concern about a certain group of medications called SGLT2 Inhibitors. This category of drugs includes popular prescription medications such as Invokana and Farxiga. Although these drugs have been fairly 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 effects of which have landed some users in the ER.
The first trial in these case is expected in September 2018. In April 2017, the MDL panel also approved a Farxiga MDL.
Our law firm is investigating legal claims on behalf of Type 2 diabetes patients who were harmed as result of the use of Invokana (or Invokamet) or Farxiga. Do you believe you have a potential claim? Call us at 800-553-8082 or get a free online case consultation. Our attorneys can help you no matter where you are.SGLT2 Inhibitors
Invokana and Farxiga fall under an umbrella of a relatively new class of medications referred to as SGLT2 Inhibitors. 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 amount of glucose that is absorbed into the bloodstream.
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 easily 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 back 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.Side Effects
After the use of 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 serious complications. Generally, people with Type 1 Diabetes are at highest risk of ketoacidosis, because their bodies do not produce insulin. Further, the body uses fat cells as opposed to glucose for energy to make up 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 the use of 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, in the event that 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 a number of side-effects that were 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 serious allergic reactions were also reported. The utility of this drug is really starting to be questioned, especially considering that clinical trials showed that people on the drug have a higher risk of developing a fungal infection. Keep in mind, this does not even take into account 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 as 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, when a drug manufacturer is sued, it is 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. If you think you were affected, the best course of action is to contact an attorney.
There are not any settlements or verdicts to report from Invokana cases just yet, given how recent some of these developments are. Because of this, it may be difficult for you to tell whether you have a valid claim or not.Contact Us
The attorneys at Miller & Zois are reviewing Invokana and other SGLT2 Inhibitor lawsuits across the country. If you think that you have a potential case, give us a call at 800-553-8082 or get a free on-line case consultation. Our lawyers can provide the information that you need going forward.