Last year, the FDA released a safety alert regarding the Viberzi drug, informing the public that the IBS drug may be among pancreatitis causes in patients with no gallbladder.

In March 2017, the U.S. Food and Drug Administration (FDA) released a safety alert informing patients and physicians that the Viberzi drug may be among pancreatitis causes for patients with no gallbladder, following reports of hospitalization and death. Should the Viberzi drug be found to be among medicines causing pancreatitis, consumers may be able to seek compensation from drug manufacturers for not warning of the pancreatitis risks.

Pancreatitis is an inflammation of the pancreas, a gland in the biliary system which produces enzymes that assist with digestion. Pancreatitis causes a variety of symptoms including abdominal pain, fever, nausea, vomiting, and a rapid pulse. Severe pancreatitis causes organ problems including injury to the heart, lungs, and kidneys.

Between May 2015 and February 2017, the FDA’s Adverse Event Reporting System (FAERS) received 120 reports of serious pancreatitis or death. According to the safety alert, 56 of the 68 patients who reported their gallbladder status had no gallbladder at the time of pancreatitis. These patients reportedly were given the recommended dose for individuals with no gallbladder, but still developed pancreatitis. Of the 56 patients who reported having no gallbladder, 21 did not abuse alcohol and 35 did not report the alcohol use status.

As of February 2017, the FDA received two reports of death associated with the use of the Viberzi drug. Both deaths occurred in patients who did not have a gallbladder. One death occurred in relation to pancreatitis and the other occurred in relation to a sphincter of Oddi spasm, a condition also affecting the biliary system.

In their safety alert, the FDA stated: “Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose.”

Symptoms of pancreatitis have reportedly occurred within with first one or two doses of taking Viberzi, and the FDA is encouraging health providers to not prescribe the Viberzi drug to 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,” the FDA stated in their safety alert.

The FDA is reportedly working with drug manufacturers to identify if and why the Viberzi drug is among drugs causing pancreatitis. Although the drug has not been proven to be among pancreatitis causes, one theory suggests that the Viberzi drug can cause spasms in the valves which control bile excretion. It is thought that these spams activate digestive enzymes before they reach the small intestine, causing the enzymes to tear the pancreas apart.

If you or a loved one do not have a gallbladder and developed pancreatitis after taking the Viberzi drug, you may qualify for legal action against drug manufacturers. Litigation may aim to hold drug manufacturers accountable for not sufficiently warning patients that Viberzi is among drugs causing pancreatitis. A Viberzi drug lawsuit could help recover compensation for medical expenses, pain and suffering, wrongful death, and more.