Invokana is a daily pill used with a proper diet and exercise program that is designed to reduce blood sugar significantly. It is the only type 2 diabetes medication that has been approved to lower the risk of three major cardiovascular conditions in adults with type 2 diabetes with existing cardiovascular disease.
Patients with type 1 diabetes have been prescribed Invokana; however, it was done as an ‘off-label’ prescription meaning the drug has not met clinical trials for this group of patients. Doctors are allowed to prescribe Invokana to their patients with type 1 diabetes, but extra precautions should be taken regarding individual risk factors.
Introduction of Invokana
Invokana (the generic name is Canagliflozin) was approved by the FDA (Federal Drug Administration) in March of 2013 as an oral medication for type 2 diabetes.
- Type 2 Diabetes
People with type 2 diabetes have a hard time turning carbohydrates found in foods into energy. The result is sugar building up in the blood. Over time, it increases the risk of blindness, heart disease, organ damage, nerve damage, and other severe health conditions. It can strike any age group, and early symptoms are difficult to detect as they begin extremely mild.
Those who have type 2 diabetes often are unaware as the disease has no symptoms. When they begin to appear, it causes increased thirst, dry mouth, frequent urination, and an increased appetite. The condition can also cause increased weight gain or loss. Other symptoms that can develop from higher blood sugar levels are blurred vision, fatigue, and headaches.
Type 2 diabetes is not detected, in most cases, until health conditions send up red flags such as sores and cuts taking a long time to heal, frequent urinary tract infections or yeast infections, or noticeably itchy skin in the groin area.
This form of diabetes can damage nerves and blood vessels in the genitals and can lead to loss of feeling, making it difficult to have an orgasm. Women will often suffer a dry vaginal area, and there is an increased risk of developing some form of sexual trouble in both men and women.
Invokana helps patients improve blood sugar levels, control high blood pressure, and lose weight. By controlling blood sugar, it helps to prevent kidney damage, nerve problems, loss of limbs, blindness, and sexual function issues. When diabetes is controlled, it lessens one's risk of stroke or heart attack. Invokana increases the removal of sugar in your kidneys.
How to Use Invokana
Invokana is a prescription medication and comes with a medication guide provided by your pharmacist. Before you begin a medication program, you should read the material presented, and ask your pharmacist or doctor if you have any questions not answered in the guide.
The medication is taken orally as directed and is usually set up on a once-a-day dosage. It should be taken before your first meal of the day, and taken the same time each day.
Any changes in your health after beginning your medication should be reported to your physician immediately.
It is recommended that a dosage of 100mg be the starting point for Invokana prescriptions. Dosages may be increased to 300mg if a patient can tolerate the 100mg dose. This drug should not be taken if you are pregnant unless the benefits from taking it outweigh the potential risk of harm to the fetus. It is also not recommended for women who are breastfeeding. If you are breastfeeding your baby, talk to your doctor regarding the potential risks this drug carries for your child.
How Invokana Works Against Diabetes
A person with type 2 diabetes, means their body is not producing enough insulin, or it is not using it properly. When this happens, glucose or blood sugar levels increase, which can lead to health complications, such as nerve problems, heart disease, kidney damage, and more.
Invokana stops glucose and does not allow kidneys to reabsorb this substance. When this blockage occurs, it raises the amount of glucose urinated and thus lowers the amount of glucose in the blood. This medication is known as an SGLT2 (selective sodium glucose co-transporter inhibitor) and works differently than other diabetes drugs.
Some of the diabetes medication on the market lowers the amount of glucose made in the liver, and others stimulate the pancreas to release more insulin, and still, others work in different ways.
Invokana is not expected to replace other diabetes medications on the market, but doctors at the Harvard Medical School are expecting it to be the first choice doctors choose when medication is needed to treat their type 2 diabetes patients.
Studies on Invokana Use
A study was conducted on patients taking Invokana by itself, and other studies were performed where patients used it in conjunction with another drug known as Metformin.
Metformin is a prescription medication, also known as a biguanide. This drug lowers the amount of sugar in the blood of patients with diabetes. Metformin decreases the amount of sugar produced in the liver and also increases the sensitivity of muscle cells to insulin. This process allows the cells to be able to remove sugar from the blood. This drug has also shown it can slow the absorption of sugars in the intestines.
Metformin is often prescribed as a treatment for type 2 diabetes for patients who are overweight or medically obese. It is recommended when exercise and diet programs fail to control blood glucose levels.
In the studies where patients took Invokana by itself, results showed they lost an average of eight-and-half pounds over a twenty-six week period, and those taking both drugs lost an average of nine pounds in the same time frame. Patients were also tested for their blood sugar levels, which showed was reduced by 7% whether Invokana was taken alone or with Metformin.
When compared to other medications such as Amaryl (glimepiride) or Januvia (sitagliptin), Invokana worked much better according to the study. This medicine reduces the amount of sugar in a person’s urine, which can often lead to yeast infections and urinary tract infections. A downside to Invokana is that it increases sugar in the urine, which could lead to a yeast or urinary tract infection.
Invokana will make a person use the bathroom more frequently, which could be a problem for women with incontinence or men who have an enlarged prostate. There are other possible side effects patients need to be aware of before taking Invokana.
Possible Side Effects from Invokana
Common side effects from taking Invokana include a yeast infection of the penis, vaginal yeast infection, along with changes in urination including having to urinate in more significant amounts, at night, and much more often. Other issues can arise from this medication:
Ketoacidosis is an increased level of ketones in the blood or urine. These disease has happened in patients with type 1 or type 2 diabetes, who have been taking Invokana. Ketoacidosis is a serious disease and has to be treated in the hospital as there is a high risk of death.
Ketoacidosis is possible with Invokana even if you have a blood sugar level of less than 250mg. Patients on this medication who experience stomach-area pain, vomiting, nausea, trouble breathing, or tiredness should stop taking it immediately and call your doctor.
Invokana has been reported to cause dehydration in some patients, which leads to dizziness, lightheadedness, fainting, and weakness. These symptoms are noticeable when the patient stands up. There is a higher risk of dehydration if you have low blood pressure, if you are taking medications to lower your blood pressure, are on a low sodium diet, or have kidney problems. The risk is also increased for those over the age of 65 or older.
- Balanitis or Balanoposthitis (Yeast Infection of the Penis)
Invokana has been reported to cause a yeast infection in the penis, which means the skin around the man’s penis becomes infected. Symptoms of these side effects include swelling of the penis, itching, and redness in the area. Other signs of infection are a foul-smelling discharge from the penis, a rash, or pain in the skin surrounding the penis.
The diabetes medication, Invokana, has been reported to increase a patient’s risk of lower-limb amputations. These amputations involve the removal of part of the foot or toe, and there have also been amputations involving the leg below or above the knee. There have even been patients who had more than one amputation involving both sides of their body.
A patient is at an increased risk of lower-limb amputation if their medical history includes a previous amputation, suffer from heart disease, or have a risk of developing heart disease, have damage to the nerves in the leg, have had diabetic foot ulcers, or have blocked or narrowed blood vessels in the leg.
Safety Announcement From FDA-
In May of 2017, the FDA reviewed two large clinical trials and concluded Invokana (canagliflozin) met the requirements to include a prominent Boxed Warning to describe amputation risks of taking this medication.
Their findings showed patients taking Invokana (canagliflozin) are to contact their healthcare physician immediately if they see signs of tenderness, pain, ulcers or sores, or any form of infection in their feet or legs.
They provided information to healthcare officials to consider health conditions before starting patients on Invokana that may have predisposed medical history that puts them at risk for amputations. The factors they need to look for include neuropathy, foot ulcers caused by diabetes, and peripheral vascular disease. They are to monitor patients receiving this medication for symptoms and signs described and discontinue Invokana if any of these complications develop.
The two clinical trials showed foot, and leg amputations happened about twice as often in patients treated with Invokana (canagliflozin) compared to those treated with a placebo.
- Vaginal Yeast Infection
Invokana has been reported to cause a vaginal yeast infection. This infection causes white or yellowish vaginal discharge, vaginal itching, and vaginal odor.
- Hyperkalemia- A high amount of potassium can develop in your blood.
- Injury to Kidneys- People who have taken Invokana reported sudden kidney injury. Symptoms they developed include a decrease in their liquid or food intake, being unreasonably sick, or unable to keep food down.
- Necrotizing Fasciitis- This disease is rare, but can occur in men or women taking Invokana. It is a severe bacterial infection that will destroy tissue under the skin in the area between and around the genitals and anus. Developing necrotizing fasciitis often requires hospitalization to treat, and may take several surgeries to remove affected tissues. This infection can lead to death.
- Fractures- Patients taking Invokana have reported a high incident of broken bones. Speak with your doctor concerning the increased risk of breaking bones before starting this medication.
Who is Not a Good Candidate for Invokana?
Patients should not consider Invokana if they are allergic to canagliflozin or any of the ingredients in Invokana:
- Active ingredients found in Invokana include hydroxypropyl cellulose, magnesium, croscarmellose sodium, lactose anhydrous, and microcrystalline cellulose. The magnesium contained in this drug vegetable-sourced. To finish the tablets, they are coated with a commercial film-coating that contains titanium dioxide, iron oxide yellow E172, and polyvinyl alcohol.
Allergic reactions may include red raised patches on the skin, rash, and swelling of the throat, tongue, lips, and face that can lead to difficulty in swallowing or breathing. Patients who are on a dialysis machine for kidney treatments should also not use this medication.
What Your Doctor Should Know When Prescribing Invokana
Your doctor needs to know your full medical history before prescribing Invokana. Information you should make sure they are aware of is if you have had an amputation, have any history of heart disease, or at risk of developing heart disease. It is also important that your physician is aware of:
- Kidney problems
- Liver problems
- History of urinary tract infections
- Problems with urination
- A low sodium diet if you are currently on one
- Diabetic foot ulcers
- Damage to the nerves of the leg
- Scheduled surgery of any type
- Loss of appetite due to an illness
- Any changes in your diet
- Pancreas problems
- Any alcohol use
- Any allergic reactions you may have
- Any other serious medical conditions
- A pregnancy, or if you are planning on becoming pregnant
- If you are breastfeeding
- Any medications you are currently taking including over-the-counter supplements
How Other Drugs May Interact with Invokana
The interaction of medications can affect how certain medicines work in your body. Not only will it affect how well the medicine works, but it can also increase the risk of side effects. The information listed here is an example of how some drugs will interact with Invokana and is not a full list of all medicines. Consult with your physician before starting this medicine if the medication you are taking is not listed to be sure you are not at risk for serious side effects.
Certain medicines such as rifampin, rifabutin, phenobarbital, phenytoin, and ritonavir can affect the removal of Invokana from your body and will, therefore, change how it works in your body. Beta-blocker medications such as glaucoma eye drops, metoprolol, propranolol can prevent the pounding/fast heartbeat associated with your blood sugar levels dropping too low. When these symptoms are masked, you do not feel the warning signs you need to be aware of are happening with your levels.
The medication, Invokana is going to make any urine test you take to show positive for glucose. You should make laboratory personnel aware as well as all doctors you work with that you are on this medication if you are required to take a urine test.
Are There any Lawsuits Against Invokana?
Invokana has many serious risks, and some of them are deadly, and some have life-altering effects such as amputations. Few of the drug’s side effects are as drastic and shocking as those surrounding the loss of a limb. It is difficult for patients to imagine that the small tablet dose of Invokana, which is taken orally could be responsible for this life-altering risk.
Some patients who have taken the prescription of Invokana have ended up losing a toe. This amputation is the most common side effect, and some patients have even lost two or more toes. A body can adjust to missing a toe over time; however, it is a difficult process. Missing a toe makes riding a bike, running, and other physical activities hard to complete.
How much losing a toe will affect your life depends on which toe is lost. For example, the big toe has a much larger role in how you walk and run than the little toe or one of the middle toes. No matter which toe is lost, it is a condition you have to live with for the rest of your life.
These amputation results from taking Invokana are one of the reasons this medication is receiving so much legal attention. From the beginning, the FDA, even though giving its approval for this drug, worried about potentially severe side effects for patients taking Invokana. The year following the approval saw hundreds of reports concerning adverse side effects. Many of the lawsuits surrounding Invokana are also concerning kidney damage, heart disease, and other life-threatening conditions in addition to the amputation results.
In December of 2016, the United States Judicial Panel on Multidistrict Litigation required the Invokana cases to be consolidated into a Multi-District Litigation (MDL 2750). The claim for these cases was that Johnson and Johnson, along with its subsidiary company, Janssen Pharmaceuticals, were not correctly conducting pre-market safety tests on Invokana. The case went on to state, the company was aware of the potential dangers, yet failed to warn doctors or patients of the possible severe medical complications and side effects associated with this medication.
- Mass Tort is a civil action that encompasses numerous plaintiffs against a few or even one defendant. The losses suffered from the plaintiffs are a result of the defendant’s causing these losses through similar or same harmful actions such as a medical device or prescription medication.
A mass tort normally involves causes of action across the country, and are not necessarily class action. Class action suits have varying characteristics that are required to meet specific criteria. A mass tort attempts to reduce the number of cases in the court system.
A mass tort is brought on by many people who suffer similar injuries on a large scale by either a defective product or defective drug. These mass tort actions are filed on behalf of the plaintiff in either a Federal or State Court. A petition to file in Federal Court forms a Multi-District Litigation (MDL) which is a federal legal process that is intended to speed the process of multiple complex cases.
The MDL for Invokana was formed in 2016 with the trials set to begin in 2018, and at this time it seems both sides are involved in a serious settlement discussion. These discussions may result in a ‘confidential settlement amount.’
Trial for this litigation was scheduled to begin in September of 2018 and consisted of twelve chosen cases (six selected by the plaintiffs and six chosen by the defendant) who had taken Invokana and developed severe side effects. Six plaintiffs who were selected had developed diabetic ketoacidosis, and another six had developed kidney damage. These plaintiffs were Group A Bellwether cases. The courts ordered the parties to select cases that showed a good faith belief and were robustly discovered and ready to be taken to trial.
Additionally, Group B Bellwether cases were established from patients who had developed cardiovascular injuries such as strokes or heart attacks. The courts requested there be six cases chosen, three from the plaintiffs and three from the defendants. Amputation cases at that time had not yet been given a trial date.
Find a Mass Tort Near Me
If you have suffered from severe side effects of Invokana such as an amputation, kidney damage, or serious heart condition, contact Consumer Alert Now at 800-511-0747. It might be possible for you to become part of a mass tort to help with medical expenses or receive other compensation for medical conditions you are suffering. Contact us today and talk to one of our representatives about how we can help you through this challenging medical experience.