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VIBERZI

Potential Risks of Viberzi (Eluxadoline)

“It is not the culture of U.S. medicine to report adverse events to the FDA.”

Dr. David Kessler, Former FDA Commissioner

Viberzi, otherwise known as Eluxadoline, from pharmaceutical company Allergan was approved by the FDA on May 27, 2015. It was marketed heavily as a promising new IBS drug for treating Irritable Bowel Syndrome with Diarrhea, or IBS-D. IBS-D involves having chronic diarrhea, abdominal pain, and discomfort. Among all available drugs for IBS-D, Eluxadoline is uniquely tied to severe pancreatitis and even death. Those who have had a gallbladder removal procedure are especially at risk. Currently, at least two deaths and 120 reports of serious pancreatitis have been associated with taking Viberzi. At least 56 of these patients had their gallbladder removed in a previous surgery; this also means that 64 patients had their gallbladder and still suffered complications from this drug.

Patients who took Viberzi are just now speaking out against the extreme adverse effects as a result of taking the IBS-D drug. Patients who had their gallbladders removed were warned about the risk of pancreatitis via a FDA announcement on March 15, 2017. Those who did not have previous gallbladder surgery were not warned about the risk for pancreatitis.

Viberzi (Eluxadoline) and Pancreatitis Complications

Viberzi has been used to treat IBS with diarrhea since 2015. While the causes of IBS-D aren’t known, there are many factors that can trigger it. Your intestines are lined with layers of muscles that contract and relax as food travels from your stomach through your intestinal tract to your rectum. With IBS-D, the contractions may be stronger and last longer which can cause gas, bloating, and diarrhea.

Viberzi works by reducing the nerve sensitivity in the intestines while slowing down the muscle contractions as food is moved through the colon. While this may seem like a good way to stop diarrhea, the problem is that Viberzi could slow down other muscles that control the flow of digestive fluids into the intestines, such as the sphincter of Oddi which opens and closes the bile duct. If the muscle relaxes and does not open, the digestive fluids will get backed up into the gallbladder and pancreas. If it’s stored in the pancreas, the enzymes will start to digest the organ causing pancreatitis that can lead to excruciating pain or even death.

In fact, the pancreatitis death on record was preceded by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single Viberzi dose. The patient died just three days after the initial dose.

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What to do if you or a loved one took Viberzi

What to do if you or a loved one took Viberzi

When the FDA warns about a drug it can be scary, especially if you or someone you know has taken it. This video gives you serious information on what you should know and point you in the direction of getting the best help.

Video: How Viberzi works

Watch to learn how IBS-D drug Viberzi works in the body, for info on the harmful side effects, and what to do if you have been injured.

Video: The History of Viberzi

This video is an overview of the IBS-D drug Viberzi (aka eluxadoline), the latest FDA warning, and the life threatening injuries it can cause.

Video: Where did Viberzi go wrong?

This video will explain why IBS-D drug Viberzi can be so dangerous. Watch now to learn more about the harmful side effects and what to do if you have been injured by Viberzi.

IBS-C Versus IBS-D

Viberzi was approved for the market as a medication for adults suffering from IBS-D. It’s important to understand the difference among the categories of IBS. IBS-C means Irritable Bowel Syndrome with Constipation while IBS-D means Irritable Bowel Syndrome with Diarrhea. IBS-M stands for Irritable Bowel Syndrome Mixed meaning that you suffer from both diarrhea and constipation. As you probably know, medications on the market treat these two conditions very differently and using the wrong medication can cause complications such as dehydration, abdominal pain, bloating, and more. If you have IBS-D, your doctor may have prescribed Viberzi.

Viberzi (Eluxadoline) Can Cause Pancreatitis Symptoms

Pancreatitis is an inflammation in the pancreas and may be caused by spasms of certain digestive system muscles in the small intestine. Acute pancreatitis can create scar tissue in the pancreas which may lead to loss of function causing digestion problems, diabetes, hospitalization or even death in extreme cases.

Here are some symptoms to look for if you or a loved one took Viberzi and suspect you may have pancreatitis:

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Rapid pulse, increased heart rate

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Abdominal pain that radiates to your back

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Abdominal pain that increases after eating

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Tenderness when touching the abdomen

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Upper abdominal pain

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Nausea

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Vomiting

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Viberzi (Eluxadoline) Settlements Landscape

Regardless of where you live in the United States, if you (or a family member) have had medical treatment to address pancreatitis and had to be hospitalized after taking Viberzi, you may be able to file for financial compensation. Patients who took this drug are reporting complaints and investigations are underway to determine the extent of hospitalizations and deaths that are directly related to the use of this medication.

Virberzi was on the market for two years before warning patients without a gallbladder of the risks of pancreatitis; that means that those patients took this drug without knowing the full story about what long term adverse effects or injuries could happen to them.

Need to Know: Before You File a Viberzi (Eluxadoline) Lawsuit

More cases are being investigated for the life-threatening consequences of pancreatitis due to taking Viberzi. Countless patients trusted the pharmaceutical company to ease their pain.The problem is that these patients were not sufficiently warned about the potential risk of pancreatitis that Viberzi can cause to patients, for both those who previously had gallbladder surgery and those who have not.

Contact a Periscope Representative to Take the Next Step >

The statute of limitations and deadlines vary by state, so it is crucial to contact Periscope Group today. We want to be certain that you get the proper representation you need if you qualify to make a claim against the manufacturer. You shouldn’t have to live with pain, and you deserve help for your current condition.

 

Viberzi Glossary of Key Terms

Irritable Bowel Syndrome Mixed (IBS-M)

When a person experiences colon issues concerning both diarrhea and constipation.

Irritable Bowel Syndrome with Constipation (IBS-C)

Colon sensitivity with symptoms such as cramping, abdominal pain, bloating, gas and/or constipation.

Irritable Bowel Syndrome with Diarrhea (IBS-D)

When a colon is more sensitive than normal, a person may experience symptoms such as an urgency to have bowel movements, abdominal pain or discomfort, gas, loose stools or frequent stools.

Opioid Receptor

Medication can cause these receptors to relax and stop muscle spasms in the gut which are associated with abdominal discomfort.

Pancreatitis

An inflammation in the pancreas which may be caused by spasms of certain digestive system muscles in the small intestine. Acute pancreatitis can create scar tissue in the pancreas which may lead to loss of function causing digestion problems, diabetes, hospitalization or even death in extreme cases.

Sphincter of Oddi

This muscle opens and closes the bile duct. If the muscle relaxes and does not open, the digestive fluids will get backed up into the gallbladder and pancreas. If it’s stored in the pancreas, the enzymes will start to digest the organ causing pancreatitis that can lead to excruciating pain or even death.

Health & Wellness Resources for Viberzi

GET YOUR FREE VIBERZI CASE REVIEW TODAY

Suffering complications from Viberzi? Settlement funds may soon be available. You could qualify for settlement funds if you: 1) Took Viberzi without a gallbladder between May 2015 to March 15, 2017, 2) Still have your gallbladder and are still taking Viberzi, 3) Suffered from pancreatitis after taking Viberzi. Get in touch today to see if you qualify:

Trademark Info: Viberzi™ is a trademark Allergan Holdings Unlimited Company and is used here for informational and product identification purposes only.

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The Step-By-Step Guide To Taking Action

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

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The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Can Talcum Powder Really Cause Mesothelioma?

For many years there has been speculation concerning whether Johnson & Johnson’s Baby Powder causes ovarian cancer. Many cases have gone to court, and in July 2018, J&J was required to pay $4.69 billion to 22 women who blamed the talc-based product for causing their ovarian cancer. 2019 isn’t looking any better for J&J as they are expected to face almost three times as many trials involving their baby powder. However, there’s a bit of a spin on a few of these cases: instead of the plaintiff’s alleging that baby powder caused ovarian cancer, some plaintiffs are going after the billion-dollar company with accusations that their mesothelioma diagnosis is linked to baby powder use from decades ago. Is there merit to this claim?

Can Talcum Powder Really Cause Mesothelioma?

What is Mesothelioma?

“Mesothelioma is a rare, aggressive form of cancer that develops in the linings of the lungs, abdomen, heart or testes. The only known cause of malignant mesothelioma is asbestos, though there are other potential risk factors. Due to a long latency period, symptoms may take 10 – 50 years to develop after exposure,” explains Mesothelioma.com. 

What makes mesothelioma especially tragic is that it’s usually discovered in an advanced stage causing there to be few options for treatment. Medical professionals will do their best to help the patient to be comfortable, but traditional go-to’s like surgery, radiation, and chemotherapy offer only minimal hope to extend life expectancy. However, each person is different so it’s critical to discuss these options, along with alternative treatments and possible outcomes, with your doctors.

What Causes Mesothelioma?

Mesothelioma is only caused by asbestos. Asbestos refers to six naturally occurring minerals that have been used for decades for its abilities to resist fire, insulate buildings, it’s anti-corrosion properties and more. By the 1970s, however, asbestos became a hot topic in the news for the health hazards it created.  

So what does asbestos have to do with baby powder?

Asbestos and talc are often formed in nature near each other. Talc is a silicate made up mainly of magnesium, silicon, and oxygen. Asbestos is also a group of silicate minerals that share the same fibrous nature. Both are extremely soft and can be broken down into microscopic pieces.

Between the 1950s and 1970s, studies were conducted which found that baby powder samples were contaminated with asbestos. By the end of the 1970s, the demand for asbestos peaked with 25 countries producing nearly 4.8 million metric tons annually. Nonetheless, asbestos was banned in many countries because of the health risks that it caused including mesothelioma.

Mesothelioma occurs when microscopic fibers of asbestos get inhaled into the lungs. These particles settle into the lung’s lining and can’t be removed. Over many years, the fibers can cause enough irritation and damage to cause lung cells to turn cancerous which is why diagnosis can take years and even decades.

Law360 explains the basis for this most recent case against J&J: “The trial, which began on July 15, involves claims that Will Ronning, Douglas Barden, David Etheridge and D’Angela McNeill-George were exposed to asbestos in the baby powder when they were babies, which caused their terminal cancer.”

Seem far fetched? Consider these findings from a 2014 study conducted by a group of scientists in New York: 

  • “Through many applications of this particular brand of talcum powder, the deceased inhaled asbestos fibers, which then accumulated in her lungs and likely caused or contributed to her mesothelioma as well as other women with the same scenario.”
  • “Initial bulk analyses of 50 samples of this product in Laboratory A showed that all of the samples contained asbestos fibers. Eighty percent contained only anthophyllite asbestos, 8% only tremolite asbestos, 8% anthophyllite and tremolite asbestos and 4% anthophyllite, tremolite, and chrysotile asbestos.”
  • “We have traced the asbestos in the talc to the mines from which it originated, into the milled grades, into the product, and finally into the lung and lymph nodes of the users of those products, including one woman who developed mesothelioma.” 

Johnson & Johnson’s Responsibility

“We do not have any organized program to settle Johnson’s baby powder cases, nor are we planning a settlement program,” Ernie W. Knewitz, a company spokesman, said in an emailed statement in the Los Angeles Times. “Rather, we will continue to vigorously defend the safety of Johnson’s baby powder in the courtroom.”

“In 2019, there are at least 21 trials on court calendars targeting J&J over tainted talc, including more than 15 in California’s courts and one in Georgia set to start in March,” states the Los Angeles Times.

Prop 65 Cancer Warning Label

The current warning label for Johnson’s Baby Powder states: “WARNING: Keep powder away from child’s face to avoid inhalation, which can cause breathing problems. Avoid contact with the eyes. For external use only.”

J&J continues to deny the results of many studies and the claims of thousands of plaintiffs that their product creates an increased risk of cancer. In fact, there may be a potential trial in California over whether or not J&J’s Baby Powder should carry a Prop 65 warning label on its bottle to provide “a ‘clear and reasonable’ warning before knowingly and intentionally exposing anyone to a listed chemical” which may cause cancer.

Should baby powder have a warning label for cancer? We’d love to hear your thoughts! Please comment on our Facebook page or share on social media (links below) with your input.

If you or a loved one were diagnosed with ovarian cancer or mesothelioma after exposure to Johnson & Johnson’s Baby Powder, please call Periscope Group today at (800) 511-3838. We want to hear your story and help in any way that we can.  

 

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Sources
“J&J Tried To Invade Atty Privilege In Talc Case, Judge Told.” Law 360. Accessed August 1, 2019. https://www.law360.com/articles/1183789/j-j-tried-to-invade-atty-privilege-in-talc-case-judge-told
“Talcum Powder as a Cause of Mesothelioma?” Mesothelioma.com. Accessed August 1, 2019. https://www.mesothelioma.com/blog/talcum-powder-as-a-cause-of-mesothelioma/
“Johnson & Johnson’s baby powder risk expands: It faces triple the cancer trials in 2019”. The Los Angeles Times. Accessed August 1, 2019. https://www.latimes.com/business/la-fi-johnsons-baby-powder-20181225-story.html
“Mesothelioma”. Mayo Clinic. Accessed August 1, 2019. https://www.mayoclinic.org/diseases-conditions/mesothelioma/diagnosis-treatment/drc-20375028
“What Is Asbestos?”. Asbestos.com. Accessed August 1, 2019. https://www.asbestos.com/asbestos/
“J&J Would Rather Fight a Cancer-Warning Lawsuit Than Let It Drop”. Bloomberg. Accessed August 1, 2019. https://www.bloomberg.com/news/articles/2019-07-27/j-j-would-rather-fight-a-cancer-warning-lawsuit-than-let-it-drop

“Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women”. NCBI. Accessed August 1, 2019. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164883/

Xeljanz and Risk of Amputation: What You Need to Know

One of the most despicable things about Big Pharma is when they know that a drug or medical device could cause a terrible health complication, and yet they fail to warn patients of this potentially life-changing problem. This is what’s happening in a current trial involving 68-year-old Arkansas resident Marilyn Stube. She took Xeljanz for four years to help her rheumatoid arthritis and ended up having both arms and legs amputated due to sepsis. Pfizer, the makers of Xeljanz, knew the risks but chose not to warn U.S. patients. 

Xeljanz and Risk of Amputation: What You Need to Know

What is Xeljanz?

Xeljanz is a relatively new medication that was introduced to the market in 2012 to address rheumatoid arthritis (RA). There are a variety of drug options available for RA, but Xeljanz works in a different way because it “is an anti-JAK, or Janus kinase inhibitor, which targets a specific cellular process that is involved in the immune response and resulting inflammation in RA. Xeljanz is the first drug of its kind,” explains Healthline. 

Xeljanz was intended to be prescribed for patients who didn’t respond to the existing drug options available for RA. However, while all medications have a risk of specific adverse effects, Xeljanz was found to have the potential to cause more serious risks that caused many doctors to decline to prescribe it to their patients.

Warning Signs

When Xeljanz was first approved to be sold in the U.S. by the FDA, the European Medicines Agency, Europe’s version of the FDA, rejected it. The European authorities deemed that this medication came with higher risks than the other available RA drugs on the market. Some of these complications could include severe infections, liver damage, gastrointestinal bleeding, increased blood pressure and cholesterol, and an increased risk of cancer. And it doesn’t just have the basic warnings that are spoken really fast at the end of a television commercial; Xeljanz has a black box warning – the highest warning given by the FDA – about how it can hinder the immune system causing major infections.

Hiding the Facts

If these dangerous complications weren’t scary enough, Pfizer failed to tell U.S. patients about the possibility of sepsis, a potentially fatal condition in which the patient is fighting a severe infection that has spread throughout the body. If a patient becomes ‘septic,’ they will likely have low blood pressure leading to poor circulation which can harm vital tissues and organs.

This is what happened in the case of Marilyn Stube. “After taking Xeljanz for four years for her rheumatoid arthritis, she started feeling pain, then fever, nausea and other symptoms in March 2017. In April of that year, she was diagnosed with septic shock, multi-organ failure, gangrene and Group A Streptococcus, requiring that she have both arms and both legs amputated at Baylor University Medical Center,” according to the complaint filed in the Western District of Arkansas.

On Xeljanz’s labels outside the U.S., they warn of the potential for sepsis which clearly shows that the company knew about the risk and hid this important fact from the American public. According to Law360, “Stube’s physician has signed a sworn declaration that he would never have prescribed Xeljanz for her if he’d known of the risk of sepsis and other ailments, saying he was relying on Pfizer’s product literature in deciding what medication was safest for Stube’s treatment.”

If you or a loved one are taking Xeljanz, it’s important to discuss the benefits and risks of your unique situation with a medical professional to determine the best medication for your condition. It’s also critical to know the potential adverse effects of each medication that you are taking so that you can know the warning signs; the quicker you can get medical care, the more likely you are to avoid severe complications.

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Sources
“Pfizer Hid Risks Of Sepsis, Amputation On Labels, Suit Says”. Law360. Accessed July 24, 2019. https://www.law360.com/articles/1179862/pfizer-hid-risks-of-sepsis-amputation-on-labels-suit-says
“Another Look At Marketing Vs. R&D In Pharma”. Science Magazine. Accessed July 24, 2019. https://blogs.sciencemag.org/pipeline/archives/2013/05/23/another_look_at_marketing_vs_rd_in_pharma
“Xeljanz: A Blessing or a Curse for Rheumatoid Arthritis Patients?”. Heathline. Accessed July 25, 2019. https://www.healthline.com/health-news/xeljanz-blessing-or-curse-for-ra-patients-100414#1
“Why was this RA med declared safe here, but not in the EU?”. Health Science Institute. Accessed July 25, 2019. https://hsionline.com/2014/08/18/european-medicines-agency/

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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