A Viberzi lawsuit may be an option for patients who who do not have a gallbladder and developed pancreatitis and other serious side effects after taking the medication. Approved by the U.S. Food and Drug Administration (FDA) in May 2016, Viberzi is a type of drug used to treat patients who suffer from irritable bowl syndrome with diarrhea (IBS-D). However, the FDA warns that the medication should not be used in patients who do not have a gallbladder, as these patients may have an increased risk of developing serious pancreatitis that could lead to hospitalization or death. Affected patients and their loved ones may be able to file a lawsuit and recover compensation with the help of a dangerous drug attorney.
For more information, contact the Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Viberzi lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Viberzi Lawsuit Commercial?
You may have seen a Viberzi lawsuit commercial on television and wondered whether you or a loved one have been affected by Viberzi and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Viberzi?
Viberzi is a prescription medication used to treat adults who suffer from irritable bowl syndrome with diarrhea (IBS-D), a condition characterized by abdominal pain, gas, sudden urges to use the bathroom and loose stools. Viberzi was approved by the FDA in May 2015.
Viberzi belongs to a class of drugs known as mu-opioid receptor agonists and works by activating receptors in the nervous system that can potentially lessen bowel contractions.
People with the following conditions should not take Viberzi:
- Severe constipation or a blockage in the intestines
- A history of gallbladder obstruction
- Digestive problems caused by a muscle valve called the sphincter of Oddi
- Severe liver disease
- A pancreas disorder
- Habitual drinking of more than three alcoholic beverages per day
According to the medication’s prescribing information, patients who use Viberzi to treat symptoms associated with IBS-D are advised stop taking the drug if unusual or severe abdominal pain develops and to avoid chronic or acute excessive alcohol use while taking the drug.
Irritable Bowel Syndrome
IBS is a relatively common, incurable intestinal disorder. According to the National Institutes of Health, patients who suffer from IBS experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States.
Irritable Bowel Syndrome with Diarrhea
IBS-D is a type of IBS characterized mainly by loose or watery stools at least 25 percent of the time. Some people who experience IBS may be able to control their symptoms by managing their diet, lifestyle and stress. However, in some cases, others may need medication and possibly counseling.
A serious complication related to the use of Viberzi to treat IBS-D is the risk of spasm of the sphincter of Oddi, potentially resulting in pancreatitis or hepatic enzyme elevation associated with acute abdominal pain.
In March 2017, the FDA issued a safety communication warning that Viberzi should not be used in patients who do not have a gallbladder. According to the alert, an FDA review discovered that these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death.
Pancreatitis may be caused by spasm of a certain digestive muscle known as the sphincter of Oddi, located in the small intestine. The FDA is working with the medication’s manufacturer, Allergan, to address these concerns.
Pancreatitis is an inflammation of the pancreas, an organ important in digestion. Symptoms may include stomach-area or abdominal pain, or pain in the upper right side of the stomach-area that may move to the back or shoulder. In some cases, nausea and vomiting may follow.
Beginning in May 2015, when Viberzi was approved, through February 2017, the FDA received 120 reports of serious cases of pancreatitis or death. Sixty-eight patients reported their gallbladder status, and 56 of those patients did not have a gallbladder and took Viberzi.
Of the 120 reports received, 76 were hospitalized, and two patients died. Those two patients did not have a gallbladder. According to the FDA, one death was associated with pancreatitis and the other was related to sphincter of Oddi spasm.
Viberzi Side Effects
Like most medications, patients may experience side effects when taking Viberzi as prescribed. The most common side effects of Viberzi include constipation, nausea and abdominal pain.
Other common side effects associated with the use of Viberzi to treat IBS-D include:
- Upper respiratory tract infection
- Runny or stuffy nose
Serious side effects potentially caused by Viberzi include sphincter of Oddi spasm and pancreatitis. According to the drug’s medication guide, patients who develop new or experience worsening stomach-area pain that may move to their back or shoulder, with or without nausea and vomiting, are advised to stop taking Viberzi and notify their doctor or health care provider as soon as possible.
Viberzi and Pancreatitis
The use of Viberzi to treat IBS-D has been reportedly linked to an increased risk of the development of pancreatitis. Pancreatitis is the inflammation of the pancreas, an organ located behind the lower part of the stomach responsible for the production of digestive enzymes. Pancreatitis may start suddenly and last for a few days, or the condition can develop over many years. People who have gallstones or use alcohol heavily may develop pancreatitis. Symptoms include abdominal pain, nausea and vomiting. Patients with pancreatitis are usually hospitalized to treat their condition.
According to the medication guide for Viberzi, symptoms associated with pancreatitis usually go away when treatment with Viberzi is stopped. The risk of developing pancreatitis increases in patients who drink more than three alcoholic drinks a day.
Other Viberzi Risks
The sphincter of Oddi is a muscular valve located in the small intestine that controls the flow of bile and pancreatic juices. A sphincter of Oddi spasm can cause an increase in liver and pancreas enzymes and inflammation of the pancreas that can potentially lead to sudden abdominal pain. The risk of sphincter of Oddi spasm is increased in patients who do not have a gallbladder. According to the drug’s prescription information, 80 percent of patients who experienced a sphincter of Oddi spasm reported their first onset of symptoms within the first week of treatment.
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Lauren A. on May 16, 2016
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Has There Been a Viberzi Recall?
Although there has not been Viberzi recall, FDA warnings suggest that the drug should not be used by patients who do not have a gallbladder, and that these patients in particular may suffer from serious complications, including sphincter of Oddi spasm and pancreatic cancer as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There an Viberzi Class Action?
There is no Viberzi class action pending as of March 2017. Viberzi lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by mu-opioid receptor agonists. Instead, if multiple lawsuits are filed against the drug’s manufacturer alleging injuries and other damages caused by Viberzi and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called a multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by pharmaceutical products.
Have There Been Viberzi Settlements?
Some cases settle early in the claims process, but it is not expected that there will be early Viberzi lawsuit settlements. In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments. After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
It is expected that Viberzi settlements will follow this pattern, although the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Viberzi Lawsuit News
- March 2017The FDA issues a safety communication warning that Viberzi should not be used in patients who do not have a gallbladder.
- February 2017As of February 2017, two deaths considered to be related to the use of Viberzi to treat IBS-D have been reported to the FDA. Both deaths occurred in patients who did not have a gallbladder.
- May 2015Viberzi is approved by the FDA for the treatment of IBS-D in adult men and women.
How an Viberzi Lawsuit Can Help
When patients suffer from severe side effects from a dangerous or defective drug, they may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Economic losses
- Medical and other treatment expenses; and
- Mental anguish
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future.
Patients who have suffered loss as a result of compulsive gambling or other compulsive behaviors are encouraged to speak with an Viberzi lawsuit attorney to learn more about their rights and remedies.