FDA ( Food and Drug Administration ) is warning that Viberzi ( Eluxadoline; in Europe: Truberzi ), a medicine used to treat irritable bowel syndrome with diarrhea ( IBS-D ), should not be used in patients who do not have a gallbladder.
An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death.
Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine.
As a result, FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns.
Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea.
Irritable bowel syndrome with diarrhea affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea.
The cause of irritable bowel syndrome with diarrhea is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. In patients with irritable bowel syndrome with diarrhea, Viberzi can help ease stomach-area or abdomen pain and improve stool consistency.
Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients.
Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder.
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.
Patients should talk to health care professional about how to control the symptoms of irritable bowel syndrome with diarrhea, particularly if they do not have a gallbladder.
Stop taking Viberzi right away and get emergency medical care if they develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder.
This pain may occur with nausea and vomiting.
These may be symptoms of pancreatitis, an inflammation of the pancreas an organ important in digestion; or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut. ( Xagena2017 )
Fonte: FDA, 2017