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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:

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.

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

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

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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

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

There are many controversial issues that political candidates build their platforms on, and public health and the environment are certainly hot topics. Congresswoman Tulsi Gabbard (D-Hawaii) is the first federal legislator and presidential candidate to call for a ban on Roundup weedkiller and we’re thrilled that she’s bringing this important topic to the forefront of political debate.

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

Financial Contributions and Political Support

It’s no secret that mega corporations give financial contributions to political candidates and officials, not to mention lobbyists. In fact, Monsanto’s website even admits:

“Monsanto is committed to participating constructively and transparently in the political process, as such participation is essential to the Company’s long-term success. Our approach on corporate political contributions is driven by the significant impact that public policy decisions can have on our business and on the interests of our stakeholders.”

Fortunately, these political contributions are open to the public to view, so here are some numbers to think about:

Paid to the House of Representatives in 2013

Total paid by Monsanto to Democrats: $72,000
Total paid by Monsanto to Republicans: $190,500

Paid to Senate in 2013

Total paid by Monsanto to Democrats: $37,500
Total  paid by Monsanto to Republicans: $85,000

Contributions to Federal Candidates, 2018 cycle

Total Contributions from this PAC to federal candidates: $315,000 (33% to Democrats, 67% to Republicans)

House: Total to Democrats: $92,500; Total to Republicans: $193,500
Senate: Total to Democrats: $23,500; Total to Republicans: $41,500

When you consider the bills and political decisions that involve adding a warning label to the products, banning glyphosate, use on city property, and more, Monsanto’s contributions are having an impact on government regulations and thereby public health and safety.  

This is precisely why it’s so refreshing to hear that Congresswoman Tulsi Gabbard is standing up against Bayer (who acquired Monsanto in 2018) by stating on Twitter, “I’ve said it before, I’ll keep saying it: Ban roundup! It’s long past time we stopped relying on corrupt corporations with a profit incentive to fund science telling us their chemicals are ‘safe.’ Victims shouldn’t have to go to trial to get the truth.”

Between the two recent California trials that found in favor of the plaintiffs who were diagnosed with cancer due to use of Roundup, new studies that found that Roundup causes a 40% increased risk of cancer, and LA County’s recent ban of Roundup on county property, hopefully more politicians will listen to researchers and their constituents and ban Roundup.

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Sources
“Presidential Candidate Says ‘Ban Roundup!’” Organic Consumers Association. Accessed April 4, 2019. https://www.organicconsumers.org/blog/presidential-candidate-says-ban-roundup#close
“Extensive List of Politicians Paid Off By Monsanto”. Natural Society. Accessed April 4, 2019. http://naturalsociety.com/list-politicians-paid-off-by-monsanto/
“Political Disclosures”. Monsanto. Accessed April 4, 2019. https://monsanto.com/company/governance/political-disclosures/
“Monsanto Co.” Open Secrets. Accessed April 5, 2019. https://www.opensecrets.org/pacs/pacgot.php?cmte=C00042069

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

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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