What is Invokana?
Serious Side Effects Before FDA Approval
Certain side effects of using Invokana appeared before its manufacturer even received approval. Those included heart attack, stroke and kidney damage. The FDA approved the drug anyway. It reasoned that long-term studies would be performed to learn more about the drug’s safety.
The Dangers of Invokana’s Side Effects
In 2015, a female user of Invokana in California filed a lawsuit against the drug’s manufacturer after being hospitalized for ketoacidosis. That single case has now mushroomed into more than 1,100 other cases across the United States. New cases are expected to be filed. Ketoacidosis isn’t the only adverse issue involving Invokana. Other lawsuits have raised issues involving leg, foot and toe amputations, kidney damage, pancreatitis, blood clots, strokes, heart attacks and fractures due to decreased bone density. None of these possible side effects of the medication were disclosed prior to its release. Here are just some of the signs to watch for. See your doctor or go to an emergency room if you’re taking Invokana and experiencing one or more of the following symptoms:
- Abdominal pain
- Low blood pressure
- Low blood sugar
- Urinary tract infection
- Unusual fatigue
The Black Box Warning
An initial safety alert was published by the FDA in May of 2016. It advised that Invokana users have an increased risk of the need for foot or leg amputations. In 2017, the FDA issued a second alert in the form of a black box label warning advising that Invokana users faced nearly double the risk of such amputations of diabetic patients who didn’t take the drug. A black box warning is the highest level of alert that is required by the FDA for medications that are manufactured and sold in the United States.
FDA Guidelines for Invokana Users
Invokana has not been recalled by the FDA, but it has issued the following guidelines for those who are using the drug:
- See your doctor right away if you develop new pain, soreness, ulcers or infections in your feet and legs.
- Speak with your doctor before you stop taking any medications for diabetes.
- Those with a history of amputation, peripheral vascular disease, neuropathy or foot ulcers should be aware that they’re at a higher risk of amputation if they continue to use Invokana.
Common Lawsuit Allegations
The pending lawsuits against Invokana’s manufacturer allege that it could have done more to warn consumers about the drug’s risks. Rather than doing that, Janssen advertised that the drug was safe for diabetics. It even advertised that the Invokana might be effective for losing weight, reducing blood pressure and improving overall cardiovascular function. Patients who have allegedly been affected have countered by stating that they never would have taken the drug if they had known of the increased possibility of amputation or other severe side effects on a timely basis. They further allege that by virtue of the manufacturer’s failure to provide proper warnings, they were precluded from making an informed decision about using the drug.
Federal Multidistrict Litigation
A small minority of the Invokana lawsuits have been filed in state courts across the country. About 90 percent of them have been filed in the various federal district courts. For purposes of convenience and fairness, when a large number of federal lawsuits are filed against a drug manufacturer, they are often combined into a single group of cases and handled as multidistrict litigation. This is something different than a class action. The Invokana cases have been organized into federal multidistrict litigation in New Jersey. The first federal Invokana trial is set for September of 2018.
The statute of limitations is an issue that can arise in any case, but there still might be time for you to file your Invokana lawsuit. Companies like Johnson & Johnson and Janssen Pharmaceuticals have retained highly trained and experienced defense attorneys to litigate claims and lawsuits against them. You deserve the same quality of representation from your lawyers. If you are in Louisville or any other part of Kentucky or Indiana, contact us today.