Viberzi / Pancreatitis
Harford, P.C., Investigating Potential Serious Harmful Effects of Viberzi
Have you or someone you know suffered pancreatitis after taking the prescription medication Viberzi? Harford, P.C., is now investigating recent reports associating pancreatitis with users of Viberzi.
What is Viberzi?
Viberzi (eluxadoline) is a prescription medication used to treat irritable bowel syndrome when the main symptom is diarrhea (“IBS-D”). The drug is manufactured and distributed by Allergan USA, Inc. and was approved by the U.S. Food and Drug Administration (“FDA”) for treatment of IBS-D in May 2015. It is prescribed as a 75 or 100 mg oral pill to be taken twice a day with food.
Viberzi is not available in a generic form at this time.
What are the potential serious side effects?
Viberzi works like a controlled substance similar to opioids and can be addictive. It activates opioid receptors within the digestive tract and decreases bowel contractions as food is moved through the intestines, leading to less diarrhea. But, the problem is that Viberzi could slow down other muscles that control the flow of digestive into the intestines, such as the “sphincter of Oddi” which opens and closes the bile duct. If this muscle relaxes and does not open, the digestive fluids will get backed up into the gallbladder and pancreas. If it is stored in the pancreas, the digestive enzymes will literally start to digest the organ and tear it down—causing pancreatitis that can lead to extreme pain and permanent injury to the heart, lungs, and kidney.
On March 15, 2017, the FDA released a Drug Safety Communications relating to serious hospitalizations and death associated with Viberzi given to patients who had undergone a prior cholecystectomy, or removal of the gallbladder. The injury articulated by the FDA related to pancreatitis and includes the following symptoms:
- Upper abdominal pain;
- Abdominal that radiates to the back;
- Abdominal pain that feels worse after eating;
- Rapid pulse;
- Abdominal tenderness.
The FDA has received over 120 reports of patient hospitalizations or death from taking Viberzi. The majority of the sickened patients did not have a gallbladder and, in many cases, the onset of symptoms started within DAYS of taking the medication.
Does the manufacturer warn of these side-effects?
Allergen changed its professional label in April 2017 to reflect that patients without a gallbladder are at an increased risk of developing “serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm.” Interestingly, the manufacturer did not warn of this serious side-effect for more than two years after the drug was approved for sale in the United States by the FDA.
What steps can I take if I have been harmed?
Harford, P.C., is currently investigating pancreatitis damage cases arising from the use of Viberzi. If you or someone you know has been injured from the use of Viberzi, please contact us immediately at (212) 390-8983 for a free case consultation. You may also complete the form on the side menu and we will contact you to set up a free consultation.