The Viberzi lawsuit claims the manufacturer of Viberzi failed to warn doctors that the drug increases the risks of pancreatitis for patients who are missing their gallbladder.
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What Do We Know About the Viberzi Lawsuits
As part of the Viberzi lawsuit filings, plaintiff attorneys argue that patients who have had their gallbladder removed have an increased risk of serious and potentially fatal pancreatitis (inflammation of the pancreas) when taking Viberzi (also known as Eluxadoline). p>
On March 15, 2017, the FDA issued a Drug Safety Communication regarding hospitalizations and deaths associated with patients who had taken Viberzi and who had undergone a cholecystectomy, the removal of the gallbladder.
At the time of its alert, the FDA had received 120 reports of patients who had suffered serious pancreatitis after taking Viberzi. Seventy-six of these patients required hospitalization; fifty-six of them had their gallbladder removed. Two of the patients died from taking Viberzi – both of whom had no gallbladder and were taking the 75 mg dosage.
Viberzi Injuries & Side Effects
Patients should only take Viberzi if they have their gallbladder, otherwise they are at risk of suffering from severe pancreatitis. Symptoms can begin very soon after first taking a Viberzi dose, even within one hour.
Symptoms of Pancreatitis
Individuals taking Viberzi should carefully watch for the following symptoms, and report the symptoms to their healthcare provider: abdominal pain, back pain, fast heart rate, fever, loss of appetite, nausea, sweating, vomiting, and weight loss. These all are signs of potential pancreatitis.
In addition to avoiding Viberzi if a patient doesn’t have a gallbladder, Viberzi is not recommended when a patient is taking the following:
- SLCO1B1 inhibitors used to treat HIV, high cholesterol, certain antibiotics, and autoimmune disorders, as well as anti-rejection drugs (administered to transplant patients)
- Opioid medications
- Lotronex (alosetron, a medication for treating IBS-D specifically in women)
- Anticholinergics (used in the treatment of gastrointestinal disorders including ulcer, diarrhea, diverticulitis and colitis)
- Bismuth subsalinylate (i.e., Pepto-Bismol and similar OTC medications)
- Crestor (rosuvastatin), a statin drug
Taking any of the above drugs in combination with Viberzi can cause a dangerous increase in the concentrations of these drugs. Furthermore, taking Viberzi at the same time as Crestor can raise the risk of rhabdomyolysis, a condition in which muscle tissue breaks down, resulting in the release of certain proteins into the bloodstream that can damage the kidneys.
Viberzi also is not recommended if a patient suffers from, or has a history of, any of the below issues:
- Consuming more than three alcoholic beverages per day
- Chronic constipation
- Digestive problems caused by the sphincter of Oddi muscle valve
- Gallbladder obstruction
- Intestinal obstruction
- Liver disease
- Pancreatic issues
This gallbladder, which is located below the liver and above the pancreas, receives bile from the liver and stores it until needed for the digestion of fats. While approximately 30% of cholecystectomy patients experience indigestion to some extent, serious complications are rare.
In the presence of Viberzi, however, patients can experience spasms of the hepatopancreatic sphincter, the valve that controls the flow of bile from the liver and interferes with the flow of digestive fluids from the pancreas. The result is severe pancreatic inflammation.
This condition is caused by digestive enzymes that are activated before being released into the small intestine. When this occurs, these enzymes begin tearing down the pancreas itself. Ultimately, acute, severe pancreatitis can cause injury to the heart, lungs, and kidneys.
Package instructions for Viberzi calls for one 100 mg tablet twice daily with food for most patients. There is also a lower recommended dosage for patients who cannot tolerate the higher dosage, who may be taking SLCO1B1 inhibitors, or who suffer from some form of liver impairment.
The FDA strongly advises cholecystectomy patients suffering from diarrhea to avoid Viberzi altogether and to use over-the-counter remedies such as Kaopectate or Pepto-Bismol as alternative treatments.
Viberzi Settlement Amounts
As of March 2021, there have been no large mass tort settlements involving Viberzi and the potential link to pancreatitis. Litigation likes this takes many years to resolve, with teams of lawyers spending millions of dollars trying to determine exactly what occurred, and how it could have been prevented.
Generally, large groups of settlements do not occur until such time as a few cases are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk.
What is the Purpose of Viberzi
Viberzi (eluxadoline) is a medication indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Originally developed by Actavis Pharma Inc., Viberzi is marketed and sold by Allergan. Both of these companies are now part of Teva Pharmaceutical Industries Ltd., a multinational drug company based in Israel.
Viberzi is part of a class of medications that operate on the body's opioid receptors. There are three distinct opioid receptors involved, identified by the Greek letters μ (mu), κ (kappa) and δ (delta).
A number of μ-opioid receptors are found in the digestive tract. When these receptors are activated, it prevents what is known as peristalsis, the action of muscles in the small intestine that move food through the system. When μ-opioid receptors (MORs) are not operating properly, peristaltic action cannot occur, and the result is constipation. It is also one of the causes of irritable bowel syndrome. Viberzi is what is known as a MOR agonist, meaning that it activates the μ-opioid receptors, thus stimulating peristaltic action in the small intestine.
The κ-opioid receptors (KORs) are involved in perception and feelings of physical pain. A number of pain relievers are KOR agonists, including Viberzi.
An antagonist is a medicine that prevents something from happening in the body. Viberzi is a δ-opioid receptor (DOR) antagonist, working with the μ-opioid receptor in the control of painful sensations.
A number of pain relievers target DORs. Specifically, DORs function as an important, but separate component of the body's central nervous system, known as the enteric nervous system. This network consists of a mesh of neurons controlling the gastrointestinal tract. By targeting DORs and preventing them from doing their job, Viberzi is intended to protect the central nervous system from harm.
The development of Viberzi's mechanism of action in targeting three different opioid receptors is based on evidence indicating that IBS-D is caused by a breakdown in communications between the nervous system and the gastrointestinal tract. The exact purpose of the medication is to treat the symptoms of IBS-D while preventing constipation and other problems that can occur with drugs that enable only MORs.
Viberzi Lawsuit News
FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi
Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients. Reported in Regulatory Affairs Professional Society – Viberzi Deaths
FDA warns of pancreatitis deaths from treatment with Allergan's IBS-D med Viberzi
The FDA has warned that patients without a gallbladder shouldn’t use the med after an agency review found an increased risk for those patients of developing serious pancreatitis that could result in hospitalization or even death. Reported in FiercePharma – Viberzi Pacreatitis
FDA and Scientific Studies Regarding Viberzi
FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Reported in FDA Viberzi Safety Communication
Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline
In an analysis of reports on eluxadoline (Viberzi) submitted to the Federal Adverse Event Reporting System, we confirmed a previously reported risk of pancreatitis associated with eluxadoline. The need for hospitalization in at least half of these instances and a recent report of 2 fatalities should prompt reassessments of the agent’s risk-benefit ratio. Reported in American Gastroenterological Association