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Allergan's Irritable Bowel Medication, Viberzi, Tied to Two Deaths, Numerous Injuries

Allergan's Irritable Bowel Medication, Viberzi, Tied to Two Deaths, Numerous Injuries

Parker Waichman is investigating potential lawsuits on behalf of individuals who suffered injuries, and to the families of those whose loved ones died, after taking Viberzi (eluxadoline), an irritable bowel medication.

FDA Warns of Increased Risk of Serious Pancreatitis with Viberzi

After two patients died after taking the drug Viberzi, the U.S. Food and Drug Administration (FDA) issued a warning concerning the increased risk of significant pancreatitis in such patients, according to the Regulatory Affairs Professionals Society (RAPS). Both patients did not have their gallbladders.

Viberzi, which is manufactured by Allergan, was cleared by the agency for use in adults for the treatment of irritable bowel syndrome (IBS) with diarrhea. Meanwhile, from May 2015-when Viberzi was initially approved-through February 2017, the federal regulators indicate that it has received 120 reports of serious cases of pancreatitis, including death, RAPS wrote. Of the 68 patients whose gallbladder status is known, 56 did not have a gallbladder and did receive the currently recommended Viberzi dosage, according to the FDA. A total of 76 patients were hospitalized and two patients died. Both patients did not have a gallbladder, noted RAPS.

"One death was associated with pancreatitis and one death was associated with sphincter of Oddi spasm. The case of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi. The case of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi. Both patients were hospitalized for treatment. Notably, the patient who experienced pancreatitis died within three days of taking the initial Viberzi dose," FDA said.

According to the University of Rochester the sphincter of Oddi is a valve. The liver manufactures bile, which is a digestive juice. Bile and pancreatic juices flow to the small intestine through a common duct that is opened and closed by a round valve. That valve, or muscle, is the sphincter of Oddi, which rarely spasms.

"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," the FDA warned. "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." "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," the FDA warned. "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."

FDA: Patients Without Gallbladder Should Not Take Viberzi

 The James L. Zadroga Compensation Act Passes

Allergan, the maker of Viberzi, has been hard at work to promote the irritable bowel syndrome-with diahrrea medication through various marketing efforts and technology partnerships, according to FiercePharma, which noted that the FDA issued a warning that patients without a gallbladder should not use Viberzi after discovering an increased risk for patients of developing serious pancreatitis that could lead to hospitalization, and in some serious cases, death.

For patients who do not have gallbladders and who were, or are, taking Allergan's Viberzi, the FDA recommends, "stop taking Viberzi right away." Also according to the FDA, "We are working with the Viberzi manufacturer, Allergan, to address these safety concerns."

FiercePharma describes the issue as a setback for Allergan, which is based in Dublin, Ireland. Allergan had been promoting Viberzi for years, noting that Viberzi was approved on the same day as its contender, Valeant's irritable bowel syndrome with diarrhea medication, Xifaxan

It's a setback for the Dublin drugmaker, which has been pushing hard to expand use of the med since winning a May 2015 approval on the same day as Valeant's IBS-D contender, Xifaxan (rifaximin).

To do so, it's joined forces with a world champion paratriathlete to encourage patients to speak with physicians sooner, inked a pact with a population health management specialist to develop monitoring tools for doctors, and rolled out a set of online resources for patients to help identify and manage symptoms.

Still, despite the efforts-and Valeant's turnover issues-it's Xifaxan that has the revenue lead. Viberzi drummed up just $94.3 million in 2016, while Xifaxan-which is also approved to treat hepatic encephalopathy-recorded $251 million in the fourth quarter alone.

FDA

FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

Safety Announcement

The U.S. Food and Drug Administration (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, we are working with the Viberzi manufacturer, Allergan, to address these safety concerns.

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. The gallbladder is an organ that stores bile, one of the body's digestive juices that helps in the digestion of fat. 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.

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.

Physicians can consider both over-the-counter (OTC) or FDA-approved prescription medicines to treat symptoms associated with IBS-D such as OTC bismuth subsalicylate (Kaopectate and Pepto-Bismol), OTC loperamide (Imodium), and prescription medicine diphenoxylate/ atropine (Lomotil) for diarrhea. Also consider OTC medicines for gas relief such as simethicone (Gas-X, Mylicon). Other FDA-approved prescription medicines for IBS-D include alosetron hydrochloride (Lotronex) and the antibiotic rifaximin (Xifaxan).

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.

From May 2015, when Viberzi was first approved, through February 2017, FDA received 120 reports of serious cases of pancreatitis or death.* Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of Viberzi. Seventy-six patients were hospitalized, of which two patients died. These two patients did not have a gallbladder. Some cases of serious pancreatitis or death also reported sphincter of Oddi spasm (n=6) or abdomen pain (n=16) (see Data Summary).

We urge patients and health care professionals to report side effects involving Viberzi (eluxadoline) or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.

*The cases were reported to the FDA Adverse Event Reporting System (FAERS).

  • Facts about Viberzi (eluxadoline)
  • Additional Information for Patients
  • Additional Information for Health Care
  • Professionals
  • Data Summary


 

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