FDA Confirms Invokana and Invokamet Lead to Amputations in Some Patients. The United States Food and Drug Administration (FDA) issued a warning to users of the popular Type-2 diabetes drug Invokana and Invokamet (referred to collectively as Invokana) that taking the medication could ultimately lead to amputations of the lower extremities. The company that makes Invokana, Janssen Pharmaceuticals, Inc., is a subsidiary of Johnson & Johnson. Janssen never warned patients that they could lose their feet and legs solely because they took this medication. Janssen now includes a warning to that effect on the packaging of Invokana, but for some patients who received the drug without being warned, it is too late.
Parker Waichman LLP represents people who were injured by large pharmaceutical companies like Janssen and Johnson & Johnson. These patients took the medication believing it would help them. Instead, the medicine maimed them. Parker Waichman’s exemplary drug defect attorneys have earned the reputation as zealous advocates of their clients’ rights. Time is of the essence. Therefore, you should contact Parker Waichman today if you or a loved one took the Type-2 diabetes drug Invokana and suffered permanent damage from the drug.
What Is Invokana?
Invokana is the brand name for the diabetes drug canagliflozin.Janssen Pharmaceuticals designed the drug as a method of people who suffer from Type-2 diabetes to control their blood sugar. The medication helps the kidneys remove sugar from a diabetic’s blood by passing it through the kidneys and out of the body through urination. By contrast, the more traditional diabetes drugs increase insulin levels in the body. Adjusting a person’s insulin levels can lead to hypoglycemia. Hypoglycemia is a very dangerous, and potentially life-threatening condition. Furthermore, eliminating excess sugar from the body helps reduce the risk of kidney failure, loss of vision, and stroke.Johnson& Johnson recommend taking this drug in conjunction with diet and exercise to control diabetes.
Johnson & Johnson, the parent company of Janssen Pharmaceuticals, received FDA approval to market the medication in 2013. Now, over 1 million people — out of the 26 million people diagnosed with Type-2 diabetes — use Invokana to treat their diabetes. While once touted as a medication from which people with diabetes could reap enormous success, many people suffer from debilitating side effects such as amputation and diabetic ketoacidosis, among others, from taking Invokana. Many of those unfortunate people have filed lawsuits against Johnson & Johnson claiming that the company failed to warn them about the possibility of losing a limb and other side effects. Additionally, the plaintiffs alleged that the drug is not as effective as Janssen and Johnson & Johnson claim.
In May of 2016, the FDA issued a communication about the recently discovered potential health risks from taking Invokana. However, the FDA first became aware of the possible health risks from diabetic ketoacidosis in May of 2015. Diabetic ketoacidosis occurs when there is an insufficient amount of insulin in the body to interact with sugar to produce energy for the body. When insulin levels plummet, the body begins burning fat as fuel, and the by-product is called ketones. Ketones continue to build in the bloodstream until the ketones poison the body.
There are numerous symptoms of diabetic ketoacidosis. They are:
- Excessive thirst,
- Uncontrolled urination,
- Sweet-smelling breath,
- Stomach pain, and
In May of 2016, the FDA learned that Invokana could lead to amputations of the lower extremities. The FDA indicated that it was following two long-term trials for evidence that taking Invokana has a direct correlation with amputations of the toes, feet, and legs. At this time, the FDA announced that it had not reached a conclusion as to whether the drugs directly lead to amputations.
Notwithstanding the lack of correlation, the FDA issued warnings to diabetic patients currently taking Invokana. The FDA cautioned that patients should not stop taking their medication without their physician’s approval. Ceasing the prescription without an alternative in place has many potential costly risks such as kidney failure and possibly death. However, the FDA strongly warned patients to seek medical help if they sensed pain, infections, ulcers, or soreness in their feet while taking Invokana.
The FDA had cause for concern in May of 2016. The two trials which were on-going at the time preliminarily suggested that Invokana raises the threat of amputation of the toes, feet, and legs contrasted with a population only taking a placebo. The trials yielded the following interim results:
- 3 out of every 1,000 people taking a placebo had an amputation;
- 5 out of every 1,000 people taking 300mg every day of Invokana had an amputation; and
- 7 out of every 1,000 people taking 100mg every day of Invokana had an amputation.
The tests continued. In May of 2017, the FDA issued a “black box warning” for Invokana. A black box warning is the strongest-worded warning the FDA requires a pharmaceutical company to make. The company must affix the warning to the outside of their packaging, so it is visible to people. It cannot be buried in the fine print of a tri-fold booklet hidden in the packaging.
The two clinical trials reached their completion. The FDA made its decision to require a black box warning for Invokana based on the results of the trials. The results indicated that people taking Invokana and either had acardiovascular disease or were likely to developcardiovasculardisease were twice more likely to require an amputation while taking Invokana than a placebo. Amputations of the entire leg or a portion of the leg were infrequent. Some patients did require the amputation of both limbs. However, the most common amputation was from the mid-foot to the toes.
The FDA issued warnings to patients taking Invokana. The FDA cautioned that anyone who observes new pain, swelling, ulcers, sores, soreness, tenderness, in the legs and feet. Again, the FDA advised patients to continue to take their medication as directed but speak with their doctor immediately about their concerns.
The FDA announced that physicians should evaluate their patients to see if Invokana is the appropriate medication for them. The FDA recommended to physicians that they should not prescribe this medicine to their patients if their patients were candidates for cardiovascular disease or had cardiovascular disease.
Multi-district litigation (MDL) is currently on-going in the United States District Court for the District of New Jersey involving Invokana. Other cases are pending in different courts through the U.S. as well. For example, those cases pending in the Eastern District of Pennsylvania were included in the New Jersey MDL, increasing the total number of claims to well over 200.
These cases are proceeding through the discovery phase. The court scheduled a bellwether trial for September of 2018. The purpose of a bellwethertrial is to demonstrate to the court and the parties how the other cases might go if they went to trial. A bellwether case is a representative case of the entire group. It is not a class action lawsuit at this time because the injured parties are readily identifiable and all suffered various injuries.
Turn to Parker Waichman LLP if You or Your Family Member Suffered Injuries or Illness After Taking Invokana
Call Parker Waichman LLP to schedule a free, no-obligation consultation to discuss your rights if you or someone you love is suffering from the side effects of taking Invokana. You can fill out our online form if it is more convenient than calling.You might be entitled to a financial award but time is of the essence. Therefore, you must call Parker Waichman LLP today at 1-800-YOURLAWYER (1-800-968-7529) and speak with one of our experienced drug defects attorneys about your rights.
Legal Help for Victims of the SGLT2 Inhibitor-Related Amputation
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If you or someone you know suffered amputation following use of a SGLT2 Type 2 diabetes drug, you may have valuable legal rights, including filing an Invokana amputation lawsuit. For a free lawsuit evaluation with a personal injury attorney, please fill complete our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.
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