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Invokana

Invokana Causes Life-Threatening Glucose Levels & Amputations

Invokana Causes Life-Threatening Glucose Levels & Amputations

“A large industry-sponsored trial found that Invokana doubled the risk of lower limb amputations compared with those taking a placebo.”

Source: Doctors debate danger of popular diabetes drug after FDA amputation warning

In 2013, a new class of drugs were released into the market for the treatment of Type 2 diabetes.

These SGLT2 (sodium/glucose cotransporter 2) inhibitors work by preventing glucose absorption in the blood, and instead allows the patient to pass glucose out through urination.

Despite initial excitement from the medical community, these drugs, namely Invokana and Invokamet, have life-threatening side effects. Unfortunately, patients have not been warned of the risks.

Many type 2 diabetes patients on Invokana and Invokamet experienced serious and life threatening complications, such as amputations.

After experiencing life-threatening side effects, many patients have sought compensation from the drug manufacturer, Janssen Pharmaceuticals.

DO YOU QUALIFY FOR COMPENSATION?

There is a limited window to pursue help. As settlements for Invokana injuries are now being negotiated, take our 30-second survey to see if you qualify… before it’s too late.

DO YOU QUALIFY FOR COMPENSATION?

There is a limited window to pursue help. As settlements for Invokana injuries are now being negotiated, take our 30-second survey to see if you qualify… before it’s too late.

Invokana Warnings In The News

Doctors debate danger of popular diabetes drug after FDA amputation warning
Many San Diego doctors are taking their patients off of Invokana, a widely used diabetes drug, after a large industry-sponsored trial found it doubled the risk of lower limb amputations compared with those taking a placebo.

With 23.1 million people in the U.S. diagnosed with diabetes, many of them are taking newer drugs to control glucose. But new research involving one of those drugs, Invokana, shows a doubled rate of leg, foot and toe amputations.

Patients are being switched to other medications even though the study’s authors say the drug’s benefits — a reduced risk of cardiovascular events including death, non-fatal heart attacks and non-fatal strokes — outweigh its risk of amputations.

The drug is prescribed for people with Type 2 diabetes. The patients in the trial were already at high risk for heart disease and other diabetes complications including amputations.

While a number of physicians interviewed said they still prescribe the drug to lower their patients’ glucose levels, attitudes among others began to change after the U.S. Food and Drug Administration on May 16 issued what’s called a black box warning about amputations.

It urges patients taking canagliflozin, sold under the brand name Invokana, Invokamet and Invokamet XR, to contact their doctors “right away” if they notice pain or tenderness, sores, ulcers or infections in their legs or feet. About half of the amputations occurring among patients in the trial were of toes, while the rest were across the foot, at the ankle, below the knee and above the knee…

Read Full Article

Johnson & Johnson Drug Prevents Heart Attacks At Cost Of Amputated Toes
Invokana, a diabetes drug made by Johnson & Johnson, decreases the risk of heart attacks and strokes, but also increases the risk of amputation, particularly of toes.

The result is a blow to J&J, and a boost to rivals Eli Lilly and Boehringer Ingelheim, who make a similar drug called Jardiance, which has been shown to reduce the risk of cardiovascular death but does not appear to carry the amputation risk.

The study also deepens the mystery about such drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which prevent the kidney from absorbing sugar from the blood. This lowers blood sugar, is good for the kidney, but leads to more urinary tract infections and weakened bones. But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s entirely unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” says Harlan Krumholz, of Yale University.

For every three heart attacks, strokes, or cardiovascular deaths prevented by Invokana, there were two amputations, 71% of them of toes or the lower foot, according to the results of the 10,142-patient study, which was funded by Johnson & Johnson. It is being presented at the annual meeting of the American Diabetes Association tonight, and published by the New England Journal of Medicine.

Heart attacks were far more common than amputations. For every year patients took the drug, there were 31.5 heart attacks, strokes, or cardiovascular deaths per 1,000 patients in the placebo group and 26.9 in the group that took Invokana, a 14% decrease…

Read Full Article

FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood
The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2)
inhibitors.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Do not stop or change your diabetes medicines without first talking to your prescriber. Health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin (see Table 1 below). The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.

A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in…

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FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

Patients should not stop or change their diabetes medicines without first talking to their health care professional. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canaglifozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.

Health care professionals should follow the recommendations in the canagliflozin drug labels. Monitor patients for the signs and symptoms described above and advise patients to seek medical advice if they experience them.

Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet…

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Janssen Pharmaceuticals Puts Type 2 Diabetes Patients at Risk

The Food & Drug Administration (FDA) approved Invokana in 2013 and subsequently Invokamet in 2014, specifically for the treatment of type 2 diabetes. These were the first SGLT2 inhibitors on the market. In 2015, the FDA issued a warning to patients and their doctors that SGLT2 inhibitors can lead to DKA (Diabetic ketoacidosis), a potentially fatal condition.

Angry and disillusioned patients are now fighting for legal compensation. After experiencing devastating side effects, these patients and their families deserve more than an apology from Janssen Pharmaceuticals.

Video Thumbnail
Invokana: Everything You Need to Know!

Invokana: Everything You Need to Know

Invokana can cause ketoacidosis and other deadly adverse effects like pancreatitis and even death. This video will walk you through what you should know if you or a loved one took this potentially controversial drug.

Invokana Lawsuits & Settlement Landscape

Cases continue to mount against Janssen Pharmaceuticals for their inadequate testing of SGLT2 inhibitors and the life-threatening consequences of using these drugs. Are you suffering from the consequences of being prescribed Invokana or Invokamet? You might be eligible for settlement funds.

For over 20 years, we’ve served as a guardian for people who need to navigate an industry that doesn’t always have their best interests at heart. We provide the information, resources, and direct connection to reputable legal counsel that people need when their lives and livelihoods are at stake. Big pharmaceutical companies cannot silence the injured—not as long as we’re around.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

DO YOU QUALIFY FOR COMPENSATION?

There is a limited window to pursue help. As settlements for Invokana injuries are now being negotiated, take our 30-second survey to see if you qualify… before it’s too late.

DO YOU QUALIFY FOR COMPENSATION?

There is a limited window to pursue help. As settlements for Invokana injuries are now being negotiated, take our 30-second survey to see if you qualify… before it’s too late.

Invokana Glossary of Key Terms

Invokana or Invokamet
Type 2 diabetes drug belonging to a new class of drug called SGLT2 inhibitors that stops glucose from being reabsorbed in the blood. The drug is associated with life threatening consequences of toxicity in the blood , including coma, death, kidney failure and amputations.

Diabetic Coma
A diabetic coma is a reversible, but life-threatening diabetes complication that causes unconsciousness. If you have diabetes or kidney failure, then dangerously high or low blood sugar can lead to diabetic coma. If left untreated, a diabetic coma can be fatal.

Diabetic Ketoacidosis
Diabetic ketoacidosis (DKA) is a serious condition in which the body produces high levels of acid in the blood resulting in ketones. DKA occurs when the body cannot use glucose as fuel because there is not enough insulin to convert that glucose into energy.

Dialysis
Dialysis removes excess waste and water from the blood to prevent them from building up in the body. Once you lose about 85-90% of kidney function, you need dialysis to sustain life.

Glucose
A simple sugar that comes from the food we eat that fuels our cells.

Insulin
A hormone made by your pancreas to turn glucose from the food you eat into energy.

Pancreas
The pancreas is responsible for creating enzymes that help our bodies break down food into energy.

SGLT2 Inhibitors
A class of Type 2 diabetes drugs that stops glucose from being reabsorbed into the blood. This class of drugs inhibits a protein in the kidney called SGLT2 that is responsible for absorbing 90% of the glucose in the kidneys.

Type 2 Diabetes
A lifelong disease that affects the way your body processes food. With Type 2 diabetes your body either does not produce enough insulin, or it is resistant to the insulin you do produce.

Health & Wellness Resources for Invokana

GET YOUR FREE INVOKANA CASE REVIEW TODAY

Financial settlement funds are available for select patients who have suffered, or are currently suffering from, the life-threatening complications of Invokana and Invokamet. Should you choose to pursue legal action, Periscope Group has a team of experienced, dedicated advocates to guide you through the settlement process. We are here to connect you with the right legal professionals, who know how to take a stand against big pharmaceutical companies.

  • * Submit now to learn if you may be eligible for a cash settlement.

Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

Free Guide Download

The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

Free Guide Download

The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

As someone who’s had medical issues ranging from chronic pain to infertility, I’m no stranger to being poked, prodded, given a plethora of prescriptions, and feeling more like an alien abduction than a patient being presented solutions to feel better. Sound familiar?

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

And why do we subjugate ourselves to being guinea pigs to test which therapies, pills, and mechanical parts will torment our bodies? It’s simple. We’re desperate for help and we trust the men and women in scrubs and suits to honestly want to help us. The FDA’s fast tracked 510(k) process,  doctors receiving “gifts” from pharmaceutical companies for prescribing their products, and sky high drug prices are just a few examples of the many parts of the system that are broken at the expense of patient health. Here’s another important flaw with the FDA and Big Pharma: their lack of post-market medical device follow-up.

But why should you take the time to learn about this? Consider these statistics:

  • In 2018, medtech (medical technology) stocks climbed 26%.
  • About 1.4 million hip and knee replacement surgeries were performed in 2017 alone and the number continues to increase each year.
  • The U.S. medical device market was $147.7 billion in 2016 and is projected to grow to $173 billion in 2019.

If you don’t already have a medical device, chances are high that you’ll either have one or you know someone who has one. Plus, this is big money for pharmaceutical companies so a variety of products are probably going to be advertised or recommended to you. Don’t you want to make sure that something this important is proven to help and not harm you?

The FDA’s 510(k) Approval and Post-Market Follow-up Process

The FDA established the 510(k) process to promote medical innovation and approve needed products to market quickly. However, this once “noble” function has now turned into a manipulation of Big Pharma to speed devices to market to for profit and to bypass expensive testing. The 510(k) process allows the FDA to fast-track paperwork through the system as pharmaceutical companies base their devices on previously approved ones… all without human clinical trials.

There are many problems to this practice. First of all, the products that they’re comparing the new one to may have been ineffective or harmful and taken off the market (such as the case involving Protegen transvaginal mesh). Secondly, this is how 70 percent of medical devices are being approved; again, WITHOUT human clinical trials. Is it any wonder why there are so many health complications and recalls concerning medical devices?!? Finally, the FDA is understaffed and underfunded which makes approving, monitoring, and following up on drugs and medical devices a nightmare.

Post market follow-up is critical to patient safety, as the FDA explains that the requirements, “include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Let’s take a closer look at a recent example that hit the news in March 2019. Mentor Worldwide MemoryShape breast implants were approved in 2013. It came to the FDA’s attention that the company failed to enrol the required number of subjects in the post market study, had poor follow-up rates with patients (only 61 percent), and significant data wasn’t consistent.

These studies are particularly important because in 2016 it was determined that breast implants can cause breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Post-market surveillance could not only ensure the safety of those in the study, but it can provide valuable information to prevent future patients from suffering from this disease.

Post-market surveillance is a critical part of the FDA’s job and public health depends on it. To quickly approve high risk medical devices and neglect monitoring how they work is not only negligent, but it deliberately disregards the health of the millions of patients that the FDA and pharmaceutical companies claim to be helping. It’s time to put patient health first.

 

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Sources
“FDA warns J&J unit and Sientra over breast implant compliance”. Medical Device Network. Accessed March 25, 2019. https://www.medicaldevice-network.com/news/fda-warns-jj-sientra-breast-implants/
“Robots, DNA And Implantable Devices — Why 2019 Isn’t Your Dad’s Medtech”. Investor’s Business Daily. Accessed March 25, 2019. https://www.investors.com/news/technology/medical-equipment-medtech-2019-preview/
“Defenders: How medical devices are approved by the FDA and why some say it no longer works” KVUE. Accessed March 25, 2019. https://www.kvue.com/article/news/defenders-how-medical-devices-are-approved-by-the-fda-and-why-some-say-it-no-longer-works/269-2a9bfbe6-dd7d-4b2b-a0c1-6bebe24998cb
“Postmarket Requirements (Devices)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm
“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

IVC Filter Use is Declining; What Does This Mean for Patients?

There are many drugs and medical devices that start out innocent enough: they are designed to help patients address difficult medical conditions and the benefits outweigh the risks in these specific situations. However, a common problem has occurred in which products become overused, over-marketed, and either used off-label or not according to manufacturer’s directions. This is certainly the case for IVC filters. Not only were they overused, but many times they were left in patients causing added risks to patient health.

IVC Filter Use is Declining; What Does This Mean for Patients?

Fortunately, a study published in the American Journal of Roentgenology found that IVC filter sales have dropped drastically over the past decade. “Between 2009 and 2015, IVC filter utilization across the United States declined by 36.3% in the Medicare population and by 26.6% in the privately insured population,” explained a statement from the Harvey L. Neiman Health Policy Institute.

This decline in sales is a win for patients due to the overuse and risks that these devices pose. IVC filters are prongs that form a tent-like structure to trap blood clots in the inferior vena cava, a large vein that carries blood to the heart. If a blood clot enters the heart or lungs, irreparable damage could take place.

IVC filters were supposed to be used in patients who were diagnosed with blood conditions that would be harmed from use of anticoagulants. “Filters should be considered for patients who cannot be anticoagulated and for those who fail anticoagulation for proximal DVT [deep vein thrombosis] or PE [pulmonary embolism],” states Akhilesh Sista, MD, FSIR, section chief and associate professor at New York University Langone School of Medicine.

IVC filters should only be used in these extreme circumstances due to the added risk they bring to patients. IVC filter prongs may break and migrate causing tissue damage and can even lodge in the heart. It has also been found that even though these medical devices have been labeled “retrievable” – meaning they should be removed after 29 to 54 days in most cases – many doctors fail to take these devices out of their patients putting them in danger.

Clearly the decline of IVC filter sales is a win for patients. These new statistics mean that doctors are carefully analyzing patient health verses the danger of using this device. If you have one of these medical devices or have an upcoming surgery which may involve an IVC filter, be sure to discuss any questions you may have with your doctor to ensure that this is the best option for your health.

 

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Sources
“The decline of state-level IVC filter utilization”. EurekAlert!. Accessed April 8, 2019. https://www.eurekalert.org/pub_releases/2019-04/hlnh-tdo040419.php
“IVC filter overuse declining, but retrieval rates remain low”. Healio. Accessed April 8, 2019. https://www.healio.com/cardiac-vascular-intervention/venous/news/online/%7Bc384ddb8-e89b-4c26-9ee4-f514e48567da%7D/ivc-filter-overuse-declining-but-retrieval-rates-remain-low

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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