Recent Invokamet News & Information
Information about the risk of amputations from Invokamet and Invokana was first disclosed in May 2016, when the FDA issued another drug safety communication about early results from a clinical trial, which identified a large number of amputated legs and feet, particularly involving the toes.
The first Invokana lawsuits were filed in mid-2015, and several hundred cases were ultimately brought nationwide involving individuals hospitalized due to ketoacidosis, who required leg or foot amputation, or suffered kidney failure.
What Is Invokamet?
Invokamet is the combination of the generic medications Canagliflozin and Metformin. The purpose of Invokamet is to regulate high levels of blood sugar for those with type two diabetes. The drug is intended to be taken in combination with a program of a healthy diet and proper exercise. Controlling these high levels of blood sugar through dietary and other habits as well as through medication can help to prevent loss of appendages/limbs, nerve problems, sexual function issues, blindness, and kidney damage. Properly controlling one's diabetes can also reduce the risk of stroke or heart attack.
Invokamet is used to help restore the body's appropriate response to insulin that humans naturally produce. The medication also serves to improve the kidney’s ability to remove sugar, decreases the liver's production of sugar, and decreases the amount of sugar that the intestines and stomach let into the body. If Invokamet is prescribed to you, read and follow the prescription’s medication guide carefully. If your pharmacist provides you with a Patient Information Leaflet, read it before beginning the medication as well as every time you have the prescription refilled. Contact your pharmacist or doctor if any questions or concerns arise regarding Invokamet.
This oral medicine should be taken as your doctor directs you to, which is usually twice daily with meals. For best results, schedule consistent times during the day to take Invokamet, and do so regularly. Staying very hydrated will also result in the best effects (unless your doctor instructs you to do otherwise). Consult with your pharmacist and doctor regarding all other prescription and nonprescription drugs as well as homeopathic or herbal products in order to reduce any possible side effects that could result in combining Invokamet with other substances. Make sure to listen and follow the instructions your doctor and pharmacist explain to you as you may need to begin with a low dosage of Invokamet and increase the amount gradually.
As you would normally with type two diabetes, keep checking your levels of blood sugary routinely (or as your doctor directs you to). Track your results and store them in a safe place so you can discuss them and best consult your doctor on the effects of Invokamet on your body. If your results are too low or high, consult your doctor immediately as it may be best to adjust the medication, diet, or exercise program that you are using.
Manufacturer’s Warnings of Invokamet
The Invokamet prescription provides many warnings about taking the drug. In rare cases, metformin in Invoket can lead to a potentially fatal condition, lactic acidosis, if too much builds up in one’s body. This lactic acidosis condition occurs more frequently in older adults, those with liver or kidney disease, heart failure, dehydration, or use alcohol heavily. Further, surgery or scanning procedures such as an X-ray that uses iodinated contrast in combination with Invoket can lead to lactic acidosis. Be aware that lactic acidosis symptoms include irregular/slow heartbeat, difficult/fast breathing, muscle pain, cold/blue skin, chills, severe drowsiness, dizziness, unusual tiredness, and/or stomach pain alongside diarrhea/nausea/vomiting. Stop taking Invokamet and get medical attention immediately if you experience any of the above symptoms.
The other active ingredient in Invoket, canagliflozin can rarely escalate the danger of losing one's lower limb. This risk tends to be heightened for those with historical problems of foot ulcers, neuropathy (nerve issues), peripheral vascular disease (blood circulation), or heart disease. Those who have previously lost a limb are also of greater risk. If you experience any sores/swelling/redness/tenderness/pain on your lower limbs (legs or feet), these could be signs that canagliflozin is negatively affecting your body. Talk to your doctor about these previous conditions before deciding to take Invokamet.
Side Effects Not Clarified By Invokamet Manufacturer
There are many side effects to Invokamet not explained in the manufacturer's warning. Some of these relate to the serious lactic acidosis condition. In addition, early signs of lactic acidosis not mentioned in the warning include significant dry mouth, frequent urination, general weakness, or bloating/gas.
Another potential serious side effect is urinary tract infection, which can manifest as bloody/pink urine or urgent, frequent, painful, or burning urination. Kidney issues can also result from taking Invokamet, which can cause your feet or legs to swell as well as the quantity of urine your body produces. Invokamet may also cause your body to produce unusually high potassium or magnesium levels in your blood system. This large amount of potassium can cause your muscles to feel weak and your heartbeat to be slow or irregular.
While the manufacturer's warning discusses a vague side effect of sexual function issues, it does not detail the serious genital issues that can result from taking the drug. Invokamet can result in your body's production of a yeast infection of the penis or vagina. In rare, but serious cases, the pharmaceutical can give your genital or anal areas a bacterial infection. This deadly infection called Fournier's gangrene and early signs of it in biological females includes vaginal discharge, itching, burning, or odor. In biological males, the early signs include unusual discharge, swelling, itching, or redness of the penis. If you experience any of these symptoms or swelling, redness, or pain around or inside the genital or anal area, in addition to a general feeling of unwellness or fever, get medical attention immediately.
On its own, Invokamet usually does not cause hypoglycemia or low blood sugar; however, this can occur if prescribed alongside additional diabetes medications. If you aren't consuming adequate food calories or if you exercise an extremely high amount alongside taking Invokamet, then you could also experience hypoglycemia. In order to tell if you are experiencing hypoglycemia, your symptoms may include fast heartbeat, shaking, hunger, dizziness, blurred vision sudden sweating or tingling feet or hands. If you are taking Invokamet, you may also want to have glucose gel or tablets on hand to combat the low amounts of sugar in your blood. Consult your doctor on how to prepare best for moments of low blood sugar throughout the day and make sure to maintain a regular three-meal-a-day schedule. If you experience hyperglycemia or high amounts of sugar in your blood, you may experience symptoms of rapid breathing, a fruity odor on your breath, confusion, drowsiness, increased urination, thirst, or flushing. If you experience these symptoms, discuss this with your doctor as you might need to alter the medication program.
Another potential side effect not adequately described by the manufacturer's warning is dehydration. If your body loses too much water, you could experience severe kidney damage. If you aren't able to maintain enough fluids in your body or if you lose body fluid because of heavy sweating, diarrhea, or vomiting, talk to your pharmacist or doctor immediately. Other indications of dehydration include fainting, lightheadedness, dizziness, a fast heartbeat, unusual thirst or dry mouth, or a smaller amount of urination than normal.
Another serious issue of the active ingredient canagliflozin is that it can cause bone loss, which can lead to you breaking a bone. Other lifestyle factors can positively influence your bone health, including bodyweight or resistance exercise, quitting smoking tobacco, limiting or quitting alcohol consumption, eating healthy meals that include sufficient amounts of vitamin D and calcium. If you aren't able to consume adequate amounts of vitamin D or calcium, you can discuss taking supplements with your doctor.
While allergic reactions to Invokamet are rare, they need to be taken very seriously. Allergic reaction symptoms include trouble breathing, severe dizziness, rash(es), and swelling or itching, especially on the throat, tongue, or face.
Additional common and less severe expressions of side effects of Invokamet include the following: Head pain, gas, insufficient Vitamin B12, taste problems, abdomen swelling, weight loss, vulva yeast infection.
Infrequent and less severe side effects may include the following: a drop in blood pressure upon standing up, the glans or head of the penis contracting a candida infection, chills, constipation, flu-like symptoms, fingernail/toenail disease, increased bodily production of phosphate, hemoglobin or cholesterol, pounding or throbbing of the heart, indigestion, nose inflammation, or low energy.
Further rare but less severe side effects include hives, your skin becoming sensitive to the sun, ketoacidosis, or drowsiness.
Additional rare and serious side effects include the following: Giant hives, the renal pelvis and kidney contracting a bacterial infection, Acute Respiratory Distress Syndrome, diabetic ketoacidosis, decreased density or calcification of the bone, lactic acid build-up leading to increased levels of blood acidity, liver damage, reduced kidney function or disease, megaloblastic anemia, pancreatitis, urosepsis, bacteria sepsis, or genital area or perineum necrotizing fasciitis.
Discuss the significance of these potential complications or side effects before taking Invokamet. Any of the above reactions or side effects should be dealt with promptly by your healthcare professional. You may experience other side effects of Invokamet, and if you do, please contact your doctor immediately.
Invokamet's Interactions With Other Drugs
As previously mentioned, Invokamet may interact with other medications and possibly increase the risk of you experiencing severe side effects.
Pharmaceuticals that treat seizures, including phenobarbital and phenytoin, can reduce the canagliflozin in your body. Other drugs that affect the canagliflozin contained in Invokamet include ritonavir and rifamycins, the latter of which includes rifabutin and rifampin.
Many prescription drugs affect the blood sugar levels in your body and are difficult to control. Your exercise and diet habits also affect blood sugar, so consult with your pharmacist and your doctor how taking Invokamet can affect your blood sugar.
Taking Invokamet will cause your urine to test glucose positive, so let your doctors and any laboratory personnel know that you are taking the medication.
Overdose, Missed Dose, and Storage of Invokamet
If you or someone you know has taken too much Invokamet or has overdosed, leading to severe symptoms including those of trouble breathing or passing out, get emergency help immediately. Other significant symptoms of an Invokamet overdose can include irregular or slow heartbeat, rapid breathing, severe drowsiness, or severe diarrhea, vomiting, or nausea.
In addition to discussing taking Invokamet with your doctor and pharmacist, you may want to attend a local CDC diabetes education program.
Undergoing regular and medical examinations and tests will help make sure that you maintain healthy kidney and liver function, adequate levels of blood sugar, ketones, hemoglobin A1c, blood counts, cholesterol, blood pressure, bone density, and minerals including magnesium and potassium. These examinations should be performed before beginning Invokamet and throughout taking medicine. Keep proper records of lab and medical appointments so that you can consult them later.
In the case that you miss a dose of Invokamet, once you remember that you've missed it, take the dose immediately. If you remember that you've missed a dose but are close to the next scheduled one, take it at the following regular time. In no circumstances should you try and catch up by taking a double dose.
When storing your Invokamet prescription, make sure it is kept at normal room temperature and away from moisture and light. If possible, keep the medication in its original bottle so as to protect it from moisture. If you transfer the Invokamet to a bill box, make sure it is used in under 30 days. Store all of your medications in a location away from pets and children.
If you no longer need the Invokamet, or if it is expired, properly discard the medication and do not pour them down the drain or flush them down the toilet unless instructed to by your doctor. Your local waste disposal institution or your pharmacist can let you know how to properly discard the Invokamet.
FDA Reports and Complaints Against Invokamet
Since 2016, the Food and Drug Administration (FDA) has been strengthening its warning against the active ingredient canagliflozin contained in Invokamet. More specifically, they explain that taking medicines with canagliflozin increase the risk of damaging one’s kidney. The same year, the FDA revised the drug labels and warnings to discuss acute kidney injury. Canagliflozin belongs to the SGLT2 or sodium-glucose cotransporter-2 inhibitor drug class. Between March 2013 (when canagliflozin was approved) and October 2015, 101 reports of confirmable acute kidney injury cases were submitted to the FDA. Some of these cases required dialysis and hospitalization. It is likely that more similar cases occurred without being submitted to the FDA.
Between September 2015 and June 2016, the FDA also warned that Invokamet possibly increases bone fracture risks, severe urinary tract infections, diabetic ketoacidosis, and the need for lower appendage amputations (typically the toes). In 2018, the FDA acknowledged the serious, but rare risk of Fournier's gangrene infection. In this acknowledgment, the FDA warned that if you take an SGLT2 class drug such as Invokamet, and experience swelling, redness, or tenderness of the genitals or between the rectum and the genitals, experience a fever above 100.4 degrees Fahrenheit, or generally feel unwell, get medical attention right away. While this risk has been recognized by the FDA and on the Medication Guide of the drug, it has not been taken off the market.
Mass Torts and Lawsuits Involving Invokamet
As of July 2019, there have not been mass torts exclusively regarding Invokamet in the United States. However, there have been hundreds of lawsuits in multidistrict federal courts brought against Invokamet and Invokana and their manufacturer, Johnson & Johnson. Related to Invokamet, Invokana is a drug containing the same canagliflozin active ingredient to treat type two diabetes. These cases all involve people who alleged that they developed kidney damage, diabetic ketoacidosis, and other severe complications resulting from Invokamet or Invokana.
As of June 2019, product liability lawyers are still reviewing Invokana's users and their experiences with kidney failure, foot or leg amputations, heart attacks, and ketoacidosis. People who have suffered from these conditions because of the Invokana they were prescribed may be eligible for financial compensation through nationwide mass torts.
A mass tort is similar to a class action case, but usually involves a smaller group of people, and each plaintiff is treated individually. However, the lawsuits of mass tort plaintiffs are consolidated like those of a class action. Mass torts are often based on plaintiffs' injuries that result from a singular or similar product. A mass tort is often the best option to proceed in a legal case of multiple plaintiffs suing one more multiple negligent defendants if the required legal criteria for a class action are not satisfied. Read more about class actions and mass tort litigations here.
A patient using Invokamet filed a lawsuit against Johnson & Johnson in 2018 because the drug led to Fournier's gangrene and he needed his scrotum to be amputated. The international drug company, and its subsidiary, Janssen Pharmaceuticals failed to properly warn the medical community and Invokamet consumers about the risk of contracting Fournier's gangrene and other infections. The plaintiff of the case explained that he only knew that Invokamet caused his infection after the FDA released the warning earlier in 2018. In this case, the medication guide and warnings on the Invokamet prescription did not warn about the risk of Fournier's gangrene. In addition, tests of the drug were conducted individually of the active ingredients canagliflozin and metformin, not together as Invokamet is produced.
Similar situations regarding prescriptions of the drug class for canagliflozin and Invokamet, SGLT2, have recently arisen. For the twelve patients of these SGLT2 drugs, all were hospitalized and underwent surgery within months of beginning their respective pharmaceutical. The FDA found that at least one of these patients died and others underwent multiple permanent disfiguring surgeries.
For many of those who suffered hand and lower limb amputations due to Invokamet and Invokana intake including that of the plaintiff that experienced Fournier’s gangrene due to Invokamet have been consolidated into a New Jersey mass tort proceeding (MDL 2750)
In October of 2018, Janssen Pharmaceuticals announced that they would create a confidential settlement fund to resolve the mass tort and other related lawsuits in New Jersey.
A principal question that the lawsuits ask Janssen is why the pharmaceutical manufacturer did not include the potential risk of ketoacidosis on their warning label even after the FDA approved the drug in 2013 and released the warning in 2016.
The total number of cases to be resolved has not been clarified, Johnson & Johnson and Janssen agreed on a settlement with many of the 1,000 lawsuits filed in the multidistrict litigation (MDL) in New Jersey. Most of these cases alleged that Invokamet and Invokana caused amputation injuries, diabetic ketoacidosis, and acute kidney injury. Johnson & Johnson and Janssen may later settle with pending cases in the California and Pennsylvania state courts.
While the amount of money to be paid out in the settlement hasn't been released as of July 2019, the total could be in the billions. Taking a look at a similar case for a drug that would supposedly help those with type two diabetes might shed some light on the potential numbers. In 2015, Takeda, a Japanese pharmaceutical company, settled lawsuits over the company's drug Actos for $2.37 billion.
In a previous iteration of the Actos lawsuits, a man who was prescribed Actos, Terrance Allen, developed bladder cancer from using the drug and was eventually awarded an individual settlement of $38.6 million.
Find Resources For an Invokamet Lawsuit or Mass Tort Near Me
If you or a loved one have experienced negative side effects after using Invokamet, such as the ones described in this article, or any other dangerous drugs and defective medical devices, contact Consumer Alert Now at our business number 800-511-0747. Here at Consumer Alter now, we will look into what you experienced from taking Invokamet and evaluate how we can best protect you and your legal rights. We operate on a national scale so that all of our clients' personal injury or product liability case needs are met with satisfaction.
