Viberzi Potential Pancreatitis Injury Lawsuits. The U.S. Food and Drug Administration (FDA) approved Viberzi, a treatment for irritable bowel syndrome with the primary symptom, diarrhea, in May 2015. There have been at least 120 reports to the FDA Adverse Event Reporting System (FAERS) of pancreatitis or death, since that time, according to the Daily Hornet.
Viberzi (eluxadoline) is a medication that slows down muscle contractions in the intestines, thereby stopping diarrhea. However, it may also slow down the flow of digestive juices from the pancreas into the intestines. In patients without a gallbladder, this may cause digestive juices to back up into the pancreas and trigger severe inflammation (pancreatitis). Pancreatitis may occur in some cases after just one or two doses of Viberzi.
Two Deaths Linked to Viberzi
A review by the FDA found that patients without a gallbladder have an increased risk for these severe side effects that could result in hospitalization or death. As of February 2017, two deaths considered to be linked to eluxadoline have been reported by the FDA. Both deaths occurred in patients who did not have a gallbladder.
One death was associated with pancreatitis and the other was associated with sphincter of Oddi spasm or dysfunction. The patient who had pancreatitis developed acute, severe abdominal pain, nausea, and vomiting within one hour of taking a single dose of eluxadoline, said the FDA. The patient whose death was linked to the sphincter of Oddi spasm had severe abdominal pain and vomiting shortly after taking the first dose of the drug. Both patients had to be hospitalized for treatment. “Notably, the patient who experienced pancreatitis died within three days of taking the initial Viberzi dose,” the FDA said.
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According to the FDA Safety Communication
“The cause of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi. The cause of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi.”
Before taking an initial dose of Viberzi, the FDA advises that patients tell their physician if they do not have a gallbladder or have had pancreatitis, sphincter of Oddi dysfunction, liver problems, chronic constipation, bowel blockages, or drink more than three alcoholic beverages per day.
The FDA is advising health providers not to prescribe eluxadoline to patients who do not have a gallbladder and to consider alternative treatment options for these patients.
Previous Viberzi Research
Two clinical trials reported in HealthDay News in January 2016 showed that symptoms seemed to be reduced for some patients with irritable bowel syndrome with diarrhea. for at least six months. In the phase three trials, over 30 percent of patients experienced improvement in their symptoms at least half of the time they were taking Viberzi. This compared to approximately a 20 percent improvement in those taking a placebo, according to the study authors, WebMD reports.
“This drug offers another option for patients who have IBS (irritable bowel syndrome) with diarrhea who have not found relief with currently available treatment,” said lead researcher Dr. Anthony Lembo, an associate professor of medicine at Harvard Medical School in Boston.
Taken twice daily, this drug should only be used for IBS with diarrhea as the primary symptom, not for those whose main symptom is constipation. The drug treats the diarrhea and reduces stomach pain, Lembo said. However, Dr. Arun Swaminath, director of the inflammatory bowel disease program at Lenox Hill Hospital in New York City, said, “Viberzi is not a silver bullet.”
The drug helps only about one-third of patients, Swaminath said “And if you look at the difference between the placebo group and the group taking the drug, there is only a 10 percent benefit,” he said. That means 10 patients need to get the drug to find the one patient it will help, Swaminath explained, reports WebMD.
Swamiinath also said that those who benefit from the drug feel about 30 percent better on 50 percent of the days they take Viberzi. “So, this is hardly going from feeling abnormal to completely normal,” he added.
Irritable bowel syndrome causes pain or discomfort in the abdomen and changes in bowel movement patterns. IBS affects 10 percent to 15 percent of adults in the United States, according to the U.S. National Institutes of Health.
Information and Advice for Viberzi Potential Pancreatitis
If you or someone you know has been injured by medication, you may be eligible for valuable legal compensation. The attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).