Viberzi lawsuit | Pancreatitis possibly leading to death

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Viberzi is a drug that is intended to treat abdominal pain and diarrhea. It is given to patients who are suffering from a form of irritable bowel syndrome (IBS) that causes diarrhea. It acts as an opioid-receptor agonist. Beyond the normal side effects of the medication, there have been reports of pancreatitis that has been associated with use of this drug that has resulted in several deaths. This caused the FDA to issue a Drug Safety Communication. As a result, attorneys are currently performing an investigation that may lead to lawsuits against the manufacturer of Viberzi. The first lawsuits were filed in the latter part of 2018.  If you or a loved one have taken Viberzi and have suffered from pancreatitis, it is vital that you immediately contact an Viberzi lawsuit attorney to discuss the facts of your Virberzi lawsuit case.

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The Viberzi lawsuit assert that the Viberzi  manufacturer failed to alert physicians of the fact that Viberzi causes an upsurge of pancreatitis  for victims who do not have a gallbladder.  We are reviewing Viberzi lawsuits for victims who have been diagnosed with pancreatitis while having a valid medical prescription and taking Viberzi. The Viberzi lawsuit lawyers assert that victims who suffered gallbladder removal have a higher likelihood of severe or deadly pancreatitis while using Viberzi. (Eluxadoline)

“In March 2017, the FDA issued a warning against Allergan’s Viberzi (eluxadoline), which was approved in May 2015 in the US for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D). As per the FDA warning, the drug should not be used in IBS-D patients who do not have a gall bladder. From May 2015 through February 2017, the FDA received 120 reports of serious cases of pancreatitis or death. A total of 68 of these patients reported their gallbladder status to the regulatory agency, out of which 56 patients did not have a gallbladder but received the recommended doses of Viberzi.” https://www.pharmaceutical-technology.com/comment/commentfda-raises-warning-flag-over-viberzi-safety-in-ibs-d-5773857/

“A total of 76 patients were hospitalized, and two patients who did not have a gallbladder died. Sphincter of oddi spasm (n=6) and abdomen pain (n=16) were reported for some patients who had serious pancreatitis or death. Viberzi has been available in the US market since December 2015. The drug was approved for the treatment of IBS-D in the EU in September 2016 (trade name Truberzi).” https://www.pharmaceutical-technology.com/comment/commentfda-raises-warning-flag-over-viberzi-safety-in-ibs-d-5773857/

What Is Viberzi?

IBS has several different sub-variants. One of those variants is called IBS-D. Specifically, this means that the patient suffers from both abdominal pain and frequent diarrhea.  This variant accounts for nearly one third of the cases of IBS in this country.  In addition to the pain and the diarrhea, the patients still suffer from nearly all of the symptoms of IBS. In the U.S., five to seven percent of the population has been diagnosed with IBS, which means that roughly two to three percent have IBS-D. Roughly double the amount of people who have been diagnosed with the disease suffer from symptoms of the illness.

IBS-D does not result entirely from an issue with the gastrointestinal tract. Instead, it is thought to result from an interaction between the gastrointestinal tract and the nervous system.  Therefore, some treatment mechanisms can work on either the gastrointestinal tract or the nervous system. There are various ways to treat IBS-D. Some patients opt to treat this disease with standard anti-diarrhea medication. Other treatments are more intensive in nature.  IBS-D can be treated with an antibiotic or even an anti-depressant. The key to treating IBS-D is to reduce both the pain and the amount of bile acid.

Viberzi is a newer way of treating IBS-D. It was approved by the FDA for use in 2015. It is manufactured by the pharmaceutical giant Allergan and it was developed by Actavis. FDA approval came in the wake of two trials of the drug that revealed a modest improvement. In its first full year after FDA approval, Viberzi had total sales of approximately $93 million. Sales of the drug accelerated in the fourth quarter of the year, reaching $38 million. In its first full year, approximately 34,000 people were prescribed the drug.  Viberzi is taken in tablet form and is used twice daily.

Viberzi contains opioid receptors.  The specific receptors that it contains are the mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist. As such, it is considered to be a controlled substance, although there is not much risk of chemical dependency.  Viberzi is a drug that acts primarily with the central nervous system in order to treat IBS-D. Patients with IBS-D experience a large number of bowel contractions. This causes both the pain and the frequent diarrhea. However, once the opioid receptors in Viberzi have their intended effect on the nervous system, the amount of contractions is reduced, lessening the symptoms of IBS-D. This is a new way to treat IBS-D, and Viberzi is the first drug in this class of IBS-D medications.

Side Effects of Viberzi

Like any other abdominal medication, Viberzi has side effects. Common side effects include constipation, nausea, vomiting and bloating. While these are the common side effects, they are still relatively rare.

When the drug was initially introduced to the marketplace, Allergan did warn of the possibility of pancreatitis that is associated with Viberzi. However, the manufacturer stated that the pancreatitis was largely associated with the use of alcohol while taking Viberzi. After the drug was in use for several years, there were reports of severe side effects that accompanied the use of Viberzi. Specifically, there were reports of 120 cases of pancreatitis. 76 of these patients required a stay in the hospital. Two of those who were afflicted with that side effect died from it. Some of the cases of pancreatitis were caused by a sphincter of Oddi spasm. Many of the cases of pancreatitis were reported by patients who already had their gall bladder removed, although some of the cases were experienced by those who still had their gall bladder. Of the 68 patients who reported their gall bladder status, 56 had the gall bladder removed.

Reports stated that even a dose or two of Viberzi given to a patient without a gall bladder could be enough to cause pancreatitis.  This could cause immediate pain and nausea within 60 minutes, even after taking just one dose. One of the fatalities occurred just three days after the patient took Viberzi. As such, those who were taking the medication without a gall bladder were advised to consult with their physician about how to control their IBS-D. Doctors were told not to prescribe the medication to patients who did not have a gall bladder. In April 2017, the warning label was changed to reflect the risk of pancreatitis among patients without a gall bladder.

While many of the cases of pancreatitis involved patients who did not have a gall bladder, there is still come connection between the drug and the illness. This is still being monitored. It remains to be seen whether there are severe side effects that are not related to the lack of a gall bladder. Given that Viberzi is still a relatively new drug, the potential for additional side effects still exists.

Viberzi Lawsuits

In September 2018, a woman in California who had contracted pancreatitis after taking Viberzi filed a lawsuit against Allergan. The lawsuit alleged that Allergan had failed to adequately test Viberzi before bringing it to market. The FDA approval was based on the results of only two clinical trials. The complaint alleges that Allergan’s tests did not account for the risks of developing pancreatitis.  The plaintiff alleges that had the company properly tested the medication, the FDA would have known about the pancreatitis risk to warn about it. The company did know about severe abdominal pain that could result as soon as 24 hours after taking the medication. The complaint largely focuses on the grounds of failure to warn and failure to adequately test the drug. An additional lawsuit was filed in federal court in Pennsylvania in December 2018 by another woman without a gall bladder who developed the same complication after taking Viberzi.

These cases are relatively early in the process since the complaints have only recently been filed. The cases have not yet reached the discovery phase. Right now, attorneys are still investigating new potential cases against Allergan with the potential that there could be additional lawsuits.

If you or a loved one have taken Viberzi and developed pancreatitis, you should reach out to a Virberzi lawsuit attorney to receive an assessment of your case. Once you relay the facts of your case to an attorney, they can let you know whether they believe you have a viable legal claim and the manner in which you should proceed. Like any product liability suit, you will not need to pay the attorney a fee unless you are successful in achieving some sort of financial recovery. Then, you would pay the Virberzi lawsuit attorney a percentage of the proceeds of your settlement.

 

Sources:

https://www.biopharmadive.com/news/fda-warns-of-viberzi-pancreatitis-risk/438331/

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM546542.pdf

https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?DrugNameID=821&event=searchdetail.page

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