The FDA has issued a safety communication recommending that certain patients stop taking Allergan’s Viberzi, and for healthcare professionals to stop prescribing it to certain populations immediately.
Viberzi is supposed to help those with irritable bowel syndrome with diarrhea, or IBS-D, by decreasing bowel contractions, easing pain, and improving stool consistency.
Viberzi poses the most risk to individuals without a gallbladder. The FDA has received at least 120 reports of pancreatitis or death from patients taking just one or two doses of 75 milligrams of Viberzi, which is the standard recommended dosage. Of the 120 people in those reports, 76 were hospitalized and the majority that reported their gallbladder status didn’t have one. At least one patient is said to have died within three days from the resulting pancreatitis.
Viberzi was approved in May of 2015 and Allergan pushed its marketing hard. The corporation hired a world renowned, world champion paratriathlete and worked with a population health management specialist to help develop tools for doctors to monitor their patients as they took the medication. It also created and deployed an online IBS-D toolkit for patients. All of this was done in an effort to mitigate the embarrassment patients with IBS-D often feel from having to discuss the combination of intense cramping, excess gas, and bloating that can severely impact their ability to lead a normal life.
The life-threatening issues caused by Viberzi may result from a spasm of a valve in the small intestine that controls the flow of digestive juices. The FDA has urged patients to “stop taking Viberzi right away” and to “get emergency medical attention if you develop new or worsening stomach-area or abdomen pain” if you have IBS-D. In addition to diarrhea, the pain can also move to the back or shoulder area and may be accompanied by nausea or vomiting.
The cause of IBS-D is not known and it should be noted that there are alternative medications for those without gallbladders that are available over-the-counter. Kaopectate, Pepto-Bismol, and Imodium can be used to aid in the relief of diarrhea while Gas-X and Mylicon are available for gas relief. Other medications that can be prescribed for IBS-D are Lotronex and Xifaxan. Patients should speak to their doctors about the best available options for treatment.
The FDA has said it is working with Allergan to address the safety concerns with its medication. Until Viberzi can be made safe, patients without a gallbladder are urged to speak with their healthcare professionals and seek safer alternatives.
