Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder
AUDIENCE: Gatroenterology, Patient
ISSUE: FDA is warning that Viberzi (eluxadoline), 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.
See the FDA Drug Safety Communication for a Data Summary.
BACKGROUND: Viberzi is a prescription medicine used to treat irritable bowel syndrome in adults when the main symptom is diarrhea (IBS-D). IBS-D affects the large intestine and causes cramping, stomach-area or abdomen pain, bloating, gas, and diarrhea. The cause of IBS-D is not known. Viberzi works by decreasing bowel contractions, which leads to less diarrhea. In patients with IBS-D, Viberzi can help ease stomach-area or abdomen pain and improve stool consistency.
RECOMMENDATION: 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 your health care professional about how to control your symptoms of irritable bowel syndrome with diarrhea (IBS-D), particularly if you do not have a gallbladder. Stop taking Viberzi right away and get emergency medical care if you 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.
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm
美國FDA發布藥物安全警訊，Viberzi（eluxadoline）不應該使用於無膽囊的病人。美國FDA的文獻回顧發現無膽囊病人若使用Viberzi（eluxadoline）會增加發生嚴重胰臟炎(pancreatitis)之風險，進而導致住院或死亡。
Viberzi（eluxadoline）為一種治療腹瀉型腸躁症(irritable bowel syndrome with diarrhea, IBS-D)的處方藥。IBS-D影響大腸，而出現痙攣、胃痛或腹痛、脹氣和腹瀉等症狀，造成IBS-D的原因仍為未知。Viberzi（eluxadoline）藉由減少腸道收縮而減少腹瀉，同時也可緩解胃痛或腹痛。
醫療專業人員對於無膽囊的IBS-D病人應選擇Viberzi（eluxadoline）以外之治療。曾有無膽囊的IBS-D病人使用Viberzi（eluxadoline）出現胰臟炎，進而導致住院和死亡的通報案例。這些案例發生於使用正常劑量之Viberzi（eluxadoline）且不飲酒的無膽囊IBS-D病人，其症狀於服藥1-2劑後出現。
病人應向醫療專業人員討論如何控制IBS-D的症狀，特別是無膽囊的病人。若有新出現之胃痛或腹痛、胃痛腹痛之症狀惡化或伴隨噁心嘔吐、疼痛轉移至背部或肩膀，這些皆可能是胰臟炎的症狀，請立即停止服用Viberzi（eluxadoline），並盡速就醫。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm
[Posted 03/15/2017]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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