The 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, by all accounts, fairly successful when treating Type 2 diabetes. But they have produced their fair share of 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. While no deaths have been reported, there is no question that if these reports are accurate, these levels of blood acid could cause serious injury and death. Accordingly, plaintiffs’ lawyers are investigating whether there is a connection between these drugs and these high acid levels and, if so, whether these drug makers knew about these risks and simply failed to inform patients and doctors. If these dots are connected – and there is reason to think they might be – there are likely to be both serious injuries and lawsuits seeking compensation for those injuries.
The preceding paragraph was written some time ago. In May 2017, there are 230 lawsuits pending in a federal MDL in New Jersey.
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 in 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 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 the highest risk of ketoacidosis because their bodies do not produce insulin. As is such, 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 you miss 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 this potentially fatal side-effect 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 to go to the emergency room in the event that they experience any of the side effects listed above.
The FDA is not the only group concerned about this drug either. The Institute for Safe Medication Practices 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 as well. Bear 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. Some lawyers are also exploring a connection between heart attacks and these drugs.
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, lawsuits are likely to allege that the manufacturer of Invokana, Janssen, failed to warn about the risks of ketoacidosis. If you think you were affected, the best course of action is to contact an attorney.
One reason for the healthy skepticism about what the drug makers knew about these possible side effects is that diabetes drugs are a ridiculously lucrative source of profits for drug companies. So in the past, we have seen drugs rushed on to the market without the internal research necessary to make sure they are safe. Is that what happened here? This is what we need to find out.
There are not any settlements or verdicts to report from Invokana cases just yet given how recent some of these developments are. The settlement value of Invokana and Farxiga claims are still unknown because, as we have been saying, we do not have a complete handle on exactly what happened. Serious injury and death cases have the potential to be very large cases. It is early; this is a very new piece of litigation. But if you think you might have a claim, calling a lawyer now is just a good idea. Things may move quickly from here.