The FDA has issued a safety announcement warning that patients without gallbladders taking Viberzi have an increased risk of developing new or worsening stomach-area or abdomen pain due to pancreatitis, with or without sphincter or Oddi spasm, that could result in hospitalization or death.
Patients who do not have a gallbladder should not take Viberzi.
Hospitalizations related to pancreatitis have also been reported in patients with a gallbladder. Symptoms of pancreatitis can occur after just one or two 75 mg doses of Viberzi in patients who do not consume alcohol, according to the announcement.
VIBERZI FACTS YOU SHOULD KNOW:
- The FDA has issued a statement warning about serious complications associated with Viberzi.
- The time to file a Viberzi lawsuit is NOW!
The FDA warns to stop taking Viberzi right away and to seek 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, with or without nausea and vomiting.
These may be symptoms of pancreatitis, an inflammation of the pancreas, or spasm of the sphincter of Oddi, a muscular valve in the small intestine that controls the flow of digestive juices to the gut.
Viberzi (eluxadoline, Allergan) is a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D). It was approved in May of 2015.
Between the time the drug was approved and the end of February 2017, the FDA received 120 reports of serious cases of pancreatitis or death. 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.
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