Other safety alerts
|
| |
| The United States: Viberzi (eluxadoline): Drug Safety Communication - Increased risk of serious pancreatitis in patients without a gallbladder |
| |
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhoea (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 diarrhoea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhoea. The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhoea. In patients with IBS-D, 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 their health care professional about how to control their symptoms of irritable bowel syndrome with diarrhoea (IBS-D), particularly if they do not have a gallbladder. Patients are advised to 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 stomach-area or abdomen that may move to the back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis.
Please refer to the following website in FDA for details:
http://www.fda.gov/../ucm546771.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, March 16, 2017
Issued at HKT 15:00
|
| |
