Viberzi (eluxadoline), a drug to treat irritable bowel syndrome with diarrhea (IBS-D) has drawn a warning from the U.S. Food and Drug Administration (FDA) following the deaths of two patients. The patients who died did not have their gallbladders and they developed serious pancreatitis after taking Viberzi.
Viberzi received FDA approval in 2015 for use by adults with irritable bowel syndrome with diarrhea (IBS-D). From May 2015 through February 2017, the FDA received 120 reports of serious cases of pancreatitis or death, according to RAPS (Regulatory Affairs Professionals Society). The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. Viberzi can help ease abdominal pain and improve stool consistency.
Increased Risk of Pancreatitis
An FDA review found that patients without a gallbladder who take Viberzi have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the recommended dosage of Viberzi. Seventy-six patients were hospitalized and two patients died. The FDA is working with the manufacturer Allergan to address these safety concerns.
National law firm Parker Waichman can provide information and advice to people who have experienced adverse health consequences associated with prescription medications like Viberzi.
Irritable Bowel Syndrome
People with IBS-D experience abdominal pain or discomfort, gas, bloating, and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype of IBS characterized by loose or watery stools at least 25 percent of the time.
Dr. Julie Beitz, who directs the FDA’s Office of Drug Evaluation the Center for Drug Evaluation and Research, said, “For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder.” People with IBS-D often limit their activities because of their frequent need for immediate access to a bathroom. They may avoid travel and refuse to go to unfamiliar places where they are uncertain about bathroom facilities. People with IBS-D frequently miss time at work and school and do not participate in sports and leisure activities because of pain, diarrhea and other symptoms.
The FDA advises patients to ask a doctor about how to control symptoms of IBS-D particularly if the patient’s gallbladder has been removed. The FDA alert advises patients stop taking Viberzi right away and get emergency medical care if new or worsening symptoms occur. These include stomach-area or abdomen pain, pain in the upper right side of the stomach-area or abdomen that may move to the back or shoulder, and nausea and vomiting. These symptoms could indicate pancreatitis or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.
Pancreatitis is an inflammation of the pancreas—the gland that produces insulin, WebMD explains. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from food for energy or to store glucose for future use. Insulin helps to control the blood sugar level.
The symptoms of acute pancreatitis include:
- upper abdominal pain that radiates into the back; it may be aggravated by eating, especially foods high in fat
- swollen and tender abdomen
- nausea and vomiting
- increased heart rate
With proper treatment, most people recover from acute pancreatitis. But severe cases of pancreatitis can result in bleeding, tissue damage, infection, and cyst formation. Severe pancreatitis can harm vital organs such as the heart, lungs, and kidneys, and can be life threatening.
Patients often must be hospitalized for treatment with IV fluids and pain medications. In severe cases, the patient may need to be admitted to an intensive care unit (ICU) to be monitored for heart, lung, or kidney damage. Pancreatitis can result in death of pancreatic tissue and the patient may need surgery to remove the dead or damaged tissue.
The FDA advises physicians not to prescribe Viberzi to patients without a gallbladder. Some patients have developed symptoms of pancreatitis after 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.
A variety of over-the-counter (OTC) and prescription medicines are available to treat the symptoms associated with IBS-D. Kaopectate, Pepto-Bismol, Imodium and prescription Lomotil can help with diarrhea. Other prescription alternatives include Lotronex (alosetron hydrochloride) and the antibiotic Xifaxan (rifaximin).
Legal Help for Viberzi Users
If you or someone you know has suffered pancreatitis symptoms while taking Viberzi, the drug-injury attorneys at Parker Waichman can provide a free, no obligation case evaluation, contact the firm by filling out the online form or by calling 1-800-YOURLAWYER (1-800-968-7529).