What is Viberzi?
Viberzi (eluxadoline), is a medication used to treat irritable bowel syndrome (IBS) in adults where diarrhea is the main symptom. Approved by the U.S. Food and Drug Administration (FDA) in May 2015, Viberzi is a mu opioid receptor agonist, delta opioid receptor antagonist, and kappa opioid agnoist.
What does Viberzi treat?
Viberzi is used to treat irritable bowel syndrome in patients who experience diarrhea as the main symptom.
How does Viberzi work?
Viberzi works by activating receptors in the nervous system which lessens the amount of bowel contractions, reducing abdominal pain and improving stool consistency.
What is IBS?
Irritable bowel syndrome (IBS) is a condition in which the patient experiences gastrointestinal issues, including chronic abdominal pain, diarrhea, fibromyalgia, constipation, and chronic pelvic pain. Medical professionals have not determined what causes IBS. Although it is not considered a life-threatening condition, IBS can have a significant impact on a patient’s quality of life and cause a great deal of distress.
Who makes Viberzi?
Viberzi is made by Allergan.
Is Viberzi an opioid?
Yes, Viberzi is an opioid.
Is Viberzi a controlled substance?
Yes, Viberzi is a controlled substance because of the possibility that it can be abused or lead to patient dependence due to its effect on the opioid receptors in the brain.
What are the complaints about Viberzi medication?
The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication warning that patients who take Viberzi with no gallbladder could be at an increased risk of developing serious pancreatitis that could result in death or hospitalization.
The agency said that from May 2015 through February 2017 it had received 120 reports of “serious cases of pancreatitis or death” linked to the use of Viberzi IBS medication. Fifty-six of the 68 patients who reported their gallbladder status reported they did not have a gallbladder. Seventy-six patients required hospitalization. Of those, two patients—both who did not have a gallbladder-died.
Serious cases of pancreatitis reportedly occurred after as few as one or two Viberzi doses, although pancreatitis was also found in patients who used the medication over a prolonged period.
What does the FDA say about Viberzi IBS medication?
“Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder,” the FDA wrote. “Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg), and who do not consume alcohol.”
Furthermore, the FDA recommends that healthcare professionals not prescribe Viberzi to patients with no gallbladder and should instead consider alternate treatments.
What are the risks of taking Viberzi with no gallbladder?
According to the FDA, patients who take Viberzi medication with no gallbladder are at a risk of developing pancreatitis, which can require hospitalization and is potentially fatal. Although patients with a gallbladder may also be at risk, so far the risk appears to be increased in patients with no gallbladder, even when they take Viberzi at the recommended dose.
What is the Viberzi gallbladder link?
The FDA has noted that the number of patients who suffer serious side effects is higher in patients who take Viberzi with no gallbladder, suggesting that patients who do not have a gallbladder are at a higher risk of severe complications. Viberzi is typically prescribed at two dosing levels, one for patients with a gallbladder and one for patients without a gallbladder.
Is there a Viberzi recall?
No. Currently no Viberzi recall has been announced.
Have there been any Viberzi lawsuits filed?
Attorneys are currently investigating possible Viberzi lawsuits against Allergan, alleging the company failed to warn patients about the risk of taking the medication with or without a gallbladder.
What should I do if I experience serious Viberzi side effects?
If you suffer a serious Viberzi side effect such as symptoms of Viberzi pancreatitis, discontinue the medication and seek emergency medical attention immediately. Among the symptoms to watch for are:
- New or worsening pain in the abdomen or stomach
- Pain in the abdomen or stomach that moves into the shoulder
- Pain accompanied by nausea and vomiting
- Spasm of the sphincter of Oddi (a valve in the small intestine).
If you or someone you love took Viberzi and suffered pancreatitis under the following circumstances: Took Viberzi without a gallbladder between May 2015 and March 15, 2017 (the date of the FDA warning); or Are still taking Viberzi and have a gallbladder but have suffered pancreatitis (no warning has been given yet for patients with their gallbladders).
If either of those circumstances apply to you or a loved one, contact a Viberzi attorney immediately to discuss your rights and your legal options.