Have you ever taken a medication and noticed a black box on the bottle with writing inside? If you do, you should pay close attention. The black box is how the Food and Drug Administration (FDA) warns consumers that there is a serious or life-threatening risk in taking the drug. Invokana (canagliflozin) is one of those drugs.
The decision to include a black box warning on Invokana was made in 2017 after a 2016 safety alert in which rates of amputation were higher in patients taking the medication compared to those taking a placebo. In fact, the risk of amputation was found to be twice as high in those people taking Invokana. Nearly 7 out of every 1,000 patients prescribed 100 milligrams of the drug had an elevated risk. A second trial proved the findings.
The FDA said, in a statement, “Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Infokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe the risk.”
The FDA has warned that the risk most often affects the toes and middle of the foot.
What Is Canagliflozin?
Canagliflozin is intended to be used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. It works in conjunction with the patient’s kidneys to remove excess sugar from the body through the urine. By itself, canagliflozin is known as Invokana. When it’s combined with metformin, it’s known as Invokamet.
When the drug was tested clinically, it seemed to work well. People who took it reached A1C levels of less than 7 percent. Unfortunately, people soon began being diagnosed with kidney issues linked to canagliflozin, and medical providers were advised to evaluate kidney health before prescribing the drug.
How Is Invokana Taken?
When a patient is prescribed Invokana, they should take it only once a day and before their first meal. Patients are typically told that they may experience lowered blood pressure while taking the medication and should alert their doctor if they become ill with diarrhea or vomiting. Patients should be sure to drink water regularly while taking the drug.
Invokana, patients are told, is only a single part of their treatment program after being diagnosed with type 2 diabetes. Invokana will be used in conjunction with things like diet and lifestyle changes as well as weight control and regular testing of blood sugar. Although there have been side effects and reactions in some patients, others have obtained positive results.
Side Effects of Invokana
Patients who are taking Invokana are advised to call their doctor if they experience any of the following side effects of the drug:
- The feeling that you may pass out
- Burning or pain during urination
- Any signs of a genital infection
- Pain, ulcers, infections or tenderness in the feet or legs
- Signs of high levels of potassium: slow heart rate, nausea, loss of movement, weakness
- Signs of dehydration
- Ketoacidosis — vomiting, nausea, stomach pain, trouble breathing
- Kidney problems: no or little urination, swelling in the lower extremities, shortness of breath
There are 775 drugs that are known to interact negatively with canagliflozin. It is extremely important that any patient with type 2 diabetes tells their medical professional about every medication they are on, including over-the-counter supplements.
Amputations: The Real Risk of Invokana
According to several studies, both by the FDA and by the European Medicines Agency (EMA), canagliflozin has been proven to increase the risk of lower limb amputations. For patients taking a placebo, the amputation rate was 2.8 per 1,000 patients. Those taking 100 mg of canagliflozin had an amputation rate of 6.2 per 1,000, while those taking 300 mg had an amputation rate of 5.5 per 1,000.
Medical experts are still unsure how or why canagliflozin causes these issues. What is clear, however, is that taking canagliflozin and other sodium glucose cotransporter 2 inhibitors increases the risk of needing an amputation for diabetic patients. As such, canagliflozin and other similar medicines now must carry a warning label in the US and the European Union.
Fighting Invokana’s Manufacturer in Court
In the past few years, many different lawsuits have been brought against Johnson & Johnson’s subsidiary company, Janssen Pharmaceuticals, due to the risk of Invokana. According to these lawsuits, the pharmaceutical company failed to conduct pre-market safety testing. Moreover, these lawsuits claim Janssen knew about the risks, but failed to properly warn doctors and patients.
In 2016, the US Judicial Panel on Multidistrict Litigation ordered all of the Invokana lawsuits be consolidated into a Multi-District Litigation in the United States District Court, District of New Jersey. This multi-district litigation will be an ongoing case throughout 2018. There are several upcoming court proceedings:
- March 8, 2018
- April 12,2018
- May 10, 2018
- June 7, 2018
- July 19, 2018
- August 23, 2018
- September 13, 2018
- October 11, 2018
- November 15, 2018
- December 13, 2018
You need to understand that to be a part of such a lawsuit, it is not enough to simply have taken the drug. To open a case against Janssen Pharmaceuticals, you must have suffered kidney injury, ketoacidosis, amputation or another injury directly related to or caused by canagliflozin. If a person was taking canagliflozin and passed away due to injuries or complications associated with the drug, their remaining family members may qualify to file a suit.
If you believe that you have suffered some sort of injury or condition as the result of taking Invokana, reach out to our team for a free consultation. We will review your medical information and the dates of your taking the medication compared to your injuries to help you determine whether or not your case qualifies to be part of the multi-district litigation. Reach out to our team in Charlotte today for more information about your legal options and appropriate next steps.