Viberzi - Consumer Justice Foundation

Viberzi

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The widely-used prescription IBS-D drug Viberzi has been linked to reports of pancreatitis, sphincter of Oddi spasms, hospitalization and death.

Viberzi is a popular treatment for adults struggling with symptoms of irritable bowel syndrome with diarrhea (IBS-D), but serious concerns have been raised about the safety of the medication, and as of February 2017, two deaths considered to be tied to Viberzi treatment – one associated with pancreatitis and one associated with sphincter of Oddi spasm – have been reported to the FDA, both occurring in patients who did not have a gallbladder. If you or a loved one took Viberzi for irritable bowel syndrome, and you have since suffered pancreatitis or another potentially life-threatening side effect, our consumer advocates at the Consumer Justice Foundation can help. We are committed to helping patients harmed by dangerous pharmaceutical drugs, and can help put you in touch with an attorney who has experience handling Viberzi injury claims.

Viberzi Alternatives for Irritable Bowel Syndrome with Diarrhea

IBS-D is a relatively common intestinal disorder that affects approximately 10 to 15 percent of adults in the United States, and people with this condition experience loose or watery stools at least 25 percent of the time. Patients diagnosed with IBS-D may be prescribed Viberzi in an effort to reduce diarrhea and relieve abdominal pain, but with new information about the potential side effects of Viberzi treatment, it may be safer to seek alternative treatments for IBS-D, such as:

  • Increasing fiber intake
  • Peppermint oil
  • Herbal formulas
  • Probiotics
  • Psychological treatment
  • Acupuncture
  • Movement therapy
  • Meditation
  • Dietary supplements
  • Eating a healthy diet
  • Hypnosis

What is Viberzi?

A prescription medication for irritable bowel syndrome occurring with diarrhea that may increase users’ risk of suffering pancreatitis and other potentially life-threatening side effects.

Viberzi (eluxadoline) is a medication prescribed to adults diagnosed with irritable bowel syndrome when the main symptom is diarrhea (IBS-D), an incurable intestinal disorder characterized by cramping, abdominal pain, gas and bloating. Viberzi was approved by the U.S. Food and Drug Administration (FDA) in May 2015, and belongs to a class of drugs known as mu-opioid receptor agonists, which means it works by activating opioid receptors in the gut to reduce bowel contractions. This can potentially lead to less diarrhea and can also help relieve abdominal pain and improve stool consistency. However, Viberzi has recently been linked to a potential risk of serious side effects possibly resulting in death, particularly among patients lacking a gallbladder, an organ that stores bile, which aids in the digestion of fat. According to the FDA, patients taking Viberzi who do not have a gallbladder may have an increased risk of developing abdominal pain due to pancreatitis with or without sphincter of Oddi spasms.

Possible Side Effects Leading to a Viberzi Lawsuit

The complications the FDA says may occur in patients taking Viberzi are severe. Among the side effects allegedly linked to Viberzi treatment are:

  • Constipation
  • Nausea
  • Vomiting
  • Abdominal pain
  • Pancreatitis – an inflammation of the pancreas
  • Sphincter of Oddi spasm – a spasm of the muscular valve in the small intestine that controls the flow of digestive juices to the gut
  • Hepatic enzyme elevation – when inflamed or injured liver cells leak higher than normal amounts of liver enzymes and other chemicals into the bloodstream
  • Pancreatic cancer
  • Hospitalization
  • Death

According to the FDA, patients should stop taking Viberzi right away and seek emergency medical care if they develop new or worsening symptoms of abdominal pain or pain in the upper-right side of the stomach-area that may move to the back or shoulder, and that may be accompanied by nausea and vomiting. Unfortunately, adverse event reports show that problems from Viberzi treatment can occur after just one or two doses of the IBS-D drug.

Link Between Viberzi and Pancreatitis

Viberzi had been on the market for less than two years when the FDA issued a report indicating that the drug had been named in 120 cases of pancreatitis or death, from the time of the drug’s approval in May 2015 through February 2017. At least 56 of these adverse event reports involved patients who lacked a gallbladder and received the recommended dose of Viberzi for patients without a gallbladder. Of those 120 cases, 76 patients were hospitalized due to complications from Viberzi, and two patients died, one within just three days of taking the initial Viberzi dose. In addition to pancreatitis, Viberzi treatment has also been linked to a spasm in the muscle of the digestive system called the sphincter of Oddi, which controls the flow of digestive juices to the gut. In fact, it is the spasming of the sphincter of Oddi that may lead to pancreatitis, in some cases.

Viberzi Lawsuits for Pancreatitis and Other Injuries

A Viberzi lawsuit may be an option for patients who do not have a gallbladder and who developed pancreatitis or another serious medical complication while taking Viberzi. It’s important to know your rights as an injured party in situations involving potentially defective prescription drugs, and an experienced Viberzi injury lawyer can ensure that you understand your legal options moving forward. Losses recovered from a Viberzi injury claim may include compensation for economic losses, mental anguish, and medical and other treatment expenses.

FDA, Viberzi and Side Effects

May 2015 – The FDA approves Viberzi for the treatment of IBS-D in adults

February 2017 – As of this date, the FDA has received 120 reports of adverse events associated with Viberzi treatment, including two deaths occurring in patients without a gallbladder.

March 2017 – The FDA issues a drug safety communication warning that patients without a gallbladder should not take Viberzi, after a review of the agency’s adverse event databased found that these patients may face an increased risk of serious pancreatitis possibly leading to hospitalization and death.

Viberzi Side Effect Studies

January 2016 – The New England Journal of Medicine publishes a study finding that Viberzi appears to reduce IBS-D symptoms for some patients for at least six months. However, there is only a 10% benefit between the Viberzi group and the placebo group, and the researchers report several adverse events in the Viberzi group, including pancreatitis, abdominal pain associated with abrupt increases in liver enzymes, and sphincter of Oddi spasms.

Why We Think Allergan Should Be Held Liable for Viberzi Side Effects

Drug manufacturing companies are responsible for the safety of their medications, and should be held accountable for manufacturing and marketing defective drugs that put patients at risk for serious and potentially life-threatening side effects. Future Viberzi lawsuits brought against Allergan will likely accuse the drug maker of the following:

  • Designing and manufacturing a defective drug
  • Understating the risks of Viberzi treatment to patients without a gallbladder
  • Failing to adequately research the risk of pancreatitis and other side effects from Viberzi
  • Failing to warn consumers about the potential side effects of the IBS-D drug, particularly among patients without a gallbladder
  • Overstating the benefits of Viberzi in the treatment of IBS-D

What should you do? If you have suffered pancreatitis, sphincter of Oddi spasms, or another serious side effect, you should contact a lawyer as soon as possible to discuss filing a Viberzi injury lawsuit.

The FDA estimates that, between May 2015 and July 2016, approximately 64,000 Viberzi prescriptions were dispensed to patients, which means tens of thousands of people across the country taking Viberzi could be at risk for serious side effects, like pancreatitis possibly leading to pancreatic cancer, hospitalization or death. Compensation may be available to individuals who developed pancreatitis or other severe complications while taking Viberzi, as well as their surviving loved ones. Contact an experienced Viberzi injury lawyer today to discuss the possibility of filing a Vibzeri lawsuit against Allergan.

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