Product News and Recalls

IBS-D Drug Could Threaten Patient Safety after Single Day’s Use

viberzi dangerous after one dayFor those who suffer from irritable bowel syndrome with diarrhea, or IBS-D, the trouble is two-fold. Physically, they endure severe abdominal pain and possible nausea on a regular basis, as well as excessive amounts of gas and sudden urges to reach the nearest bathroom. But they also face potential embarrassment over their condition and can suffer anxiety and loss of appetite. These social aspects can have dramatic impacts on their quality of life.

In May of 2015, Allergan thought it had a solution to IBS-D when the FDA approved its twice-a-day pill, Viberzi. Viberzi was designed to slow muscle contractions in the digestive tract and, as a result, slow the digestive juices that enter the intestines. The net result of this was supposed to ease pain and improve stool consistency, allowing patients to regain control of their lives.

But by February of 2017, Viberzi had proven to be extremely dangerous. The FDA had received 120 adverse event reports on the drug and as many as 76 people had been hospitalized because of it. Patients were suffering from severe inflammation of the pancreas, or pancreatitis; nausea; muscular spasms; and intense pain that moved from the abdomen to the back side of the right shoulder. Some even died.

Troubled by these events, researchers began working to find a link – some kind of common thread that ran between these incredibly dangerous and potentially fatal side effects. What they eventually discovered was that the overwhelming majority of those hospitalized were found to have no gallbladder.

Viberzi works in part by slowing down the muscles of an area of the digestive system known as the sphincter of Oddi. Without a gallbladder, the pancreas can then become overwhelmed with enzymes that can destroy it.

The FDA informed physicians of its guidance to immediately stop prescribing Viberzi to this and other at-risk populations in a safety communication issued earlier this year. That urgency was for a very good reason: research found that patients can begin experiencing these potentially deadly symptoms after just one or two doses of Viberzi: the equivalent of a single day’s use.

Allergan put considerable resources into its marketing campaign for Viberzi. The corporation hired a renowned paratriathlete to speak for the drug, created online informational kits, and even made special tracking tools for doctors to monitor their patients. All of these strategies were supposed to help reduce or eliminate the struggles that patients with IBS-D can’t help but face; including tackling the embarrassment that some contend with while discussing their condition with their doctor.

The campaigns were effective. In 2016 alone, Allergan made more than $90 million in sales from Viberzi. But in its safety communication, the FDA provides a list of much safer alternatives that also reduce the distress caused by IBS-D. They include Xiafaxan, Pepto-Bismol, Imodium, Lomotil, Gas-X, Mylicon, and Lotronex.

The FDA is reportedly working with Allergan to resolve the dangers that Viberzi presents but progress has been slow. Given that the drug could potentially put a patient’s life in danger from the moment it is ingested, patients taking Viberzi while lacking a gallbladder should speak with their physicians about the numerous alternatives that could still work to improve their quality of life.