FDA News

FDA warns IBS drug Viberzi may cause severe pancreatitis in patients without gallbladder

The FDA has issued a safety announcement warning that Viberzi should not be used in patients who do not have a gallbladder due to an increased risk for serious pancreatitis.

Hospitalizations and deaths due to pancreatitis have been reported with the use of this drug in such patients, with symptom onset occurring with just one or two 75 mg doses in patients who do not consume alcohol, according to the announcement.

Viberzi (eluxadoline, Allergan) is an orally administered mixed mu-opioid agonist and delta-opioid antagonist that was approved for diarrhea-predominant irritable bowel syndrome in May 2015. The FDA said it is working with the manufacturer to address this safety concern.

“For many people, eluxadoline (Viberzi) can positively improve how they go about their day-to-day activities,” David Nicholson, PhD, Allergan's executive vice president of research and development, told Healio Gastroenterology. “While adverse events are extremely rare, Allergan considers the safety of patients its priority and is in full agreement with the FDA that Viberzi should only be used in patients with a gallbladder, where it has been shown to be both safe and efficacious. This has been established in two phase 3 clinical studies comprising more than 2,400 patients. The updated Viberzi label reflects this new information, and we want to ensure that prescribers understand the full story around Viberzi.”

Between the time the drug was approved and the end of February 2017, the FDA received 120 reports of serious cases of pancreatitis, including two reported deaths. Of 68 patients who reported their gallbladder status, 56 did not have a gallbladder and were taking eluxadoline, mostly at the 75 mg dose recommended for patients without a gallbladder. Among these 68 patients, 21 reported they did not abuse alcohol while 35 did not report alcohol use status. Sphincter of Oddi spasm was also reported in six cases, and abdominal pain was also reported in 16 cases.

Overall, 76 patients were hospitalized, two of whom died and did not have a gallbladder. One death was linked to pancreatitis and one to Sphincter of Oddi spasm.

“Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose,” the FDA wrote.

Among the 84 cases that reported a time to onset, pancreatitis or death occurred after one or two doses in 48 patients, and serious pancreatitis occurred after prolonged use in 36 patients.

In light of these reports, the agency recommended that patients without a gallbladder should immediately stop taking eluxadoline, and that health care professionals should not prescribe the drug to such patients.

According to the safety communication, alternative diarrhea treatments include over-the-counter Kaopectate (bismuth subsalicylate, Chattem), Pepto-Bismol (bismuth subsalicylate; Procter & Gamble) and Imodium (loperamide; Johnson & Johnson), as well as prescription Lomotil (diphenoxylate/atropine; Pfizer). Further, Gas-X (simethicone; GlaxoSmithKline) or Mylicon (simethicone; McNeil) are over-the-counter alternative treatments for gas relief, and Lotronex (alosetron hydrochloride; Sebela) and Xifaxin (rifaximin; Salix) are alternative prescription medications for IBS-D. – by Adam Leitenberger

Reference:

FDA. “FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder.” Accessed March 15, 2017. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM546542.pdf

Editor’s Note: This article has been updated with comments from a representative of the drug manufacturer.

The FDA has issued a safety announcement warning that Viberzi should not be used in patients who do not have a gallbladder due to an increased risk for serious pancreatitis.

Hospitalizations and deaths due to pancreatitis have been reported with the use of this drug in such patients, with symptom onset occurring with just one or two 75 mg doses in patients who do not consume alcohol, according to the announcement.

Viberzi (eluxadoline, Allergan) is an orally administered mixed mu-opioid agonist and delta-opioid antagonist that was approved for diarrhea-predominant irritable bowel syndrome in May 2015. The FDA said it is working with the manufacturer to address this safety concern.

“For many people, eluxadoline (Viberzi) can positively improve how they go about their day-to-day activities,” David Nicholson, PhD, Allergan's executive vice president of research and development, told Healio Gastroenterology. “While adverse events are extremely rare, Allergan considers the safety of patients its priority and is in full agreement with the FDA that Viberzi should only be used in patients with a gallbladder, where it has been shown to be both safe and efficacious. This has been established in two phase 3 clinical studies comprising more than 2,400 patients. The updated Viberzi label reflects this new information, and we want to ensure that prescribers understand the full story around Viberzi.”

Between the time the drug was approved and the end of February 2017, the FDA received 120 reports of serious cases of pancreatitis, including two reported deaths. Of 68 patients who reported their gallbladder status, 56 did not have a gallbladder and were taking eluxadoline, mostly at the 75 mg dose recommended for patients without a gallbladder. Among these 68 patients, 21 reported they did not abuse alcohol while 35 did not report alcohol use status. Sphincter of Oddi spasm was also reported in six cases, and abdominal pain was also reported in 16 cases.

Overall, 76 patients were hospitalized, two of whom died and did not have a gallbladder. One death was linked to pancreatitis and one to Sphincter of Oddi spasm.

“Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose,” the FDA wrote.

Among the 84 cases that reported a time to onset, pancreatitis or death occurred after one or two doses in 48 patients, and serious pancreatitis occurred after prolonged use in 36 patients.

In light of these reports, the agency recommended that patients without a gallbladder should immediately stop taking eluxadoline, and that health care professionals should not prescribe the drug to such patients.

According to the safety communication, alternative diarrhea treatments include over-the-counter Kaopectate (bismuth subsalicylate, Chattem), Pepto-Bismol (bismuth subsalicylate; Procter & Gamble) and Imodium (loperamide; Johnson & Johnson), as well as prescription Lomotil (diphenoxylate/atropine; Pfizer). Further, Gas-X (simethicone; GlaxoSmithKline) or Mylicon (simethicone; McNeil) are over-the-counter alternative treatments for gas relief, and Lotronex (alosetron hydrochloride; Sebela) and Xifaxin (rifaximin; Salix) are alternative prescription medications for IBS-D. – by Adam Leitenberger

Reference:

FDA. “FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder.” Accessed March 15, 2017. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM546542.pdf

Editor’s Note: This article has been updated with comments from a representative of the drug manufacturer.