Stress, the foods we eat and genetics can all be contributing factors for Irritable Bowel Syndrome (IBS). Although this may be an embarrassing topic that most people don’t talk about, if you suffer from this condition, you most definitely aren’t alone. In fact, IBS affects between 25 and 45 million people in the U.S. and it’s estimated that 10-15% of the worldwide population struggles with this problem.
Viberzi (eluxadoline) is a newer drug on the market that was approved by the FDA in May 2015. It is made by Allergan and was approved for the specific use for treating IBS-D, Irritable Bowel Syndrome with Diarrhea, in adults.
This medication is an opioid that works by reducing the nerve sensitivity in the intestines. Through affecting the opioid receptors in your gut, it can slow down the muscle contractions as food is moved through the colon. This seemingly effective way to stop diarrhea can also slow down other necessary muscles that control the flow of digestive fluids into the intestines like the sphincter of Oddi which opens and closes the bile duct. If this important muscle relaxes and does not open, the digestive fluids will get backed up into the gallbladder and pancreas causing these acidic fluids to digest the organ. The result is pancreatitis that can lead to excruciating pain or even death.
On March 15, 2017, the FDA published a Drug Safety Communication for doctors and patients explaining 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.”
So what does this really mean? If you had your gallbladder removed (called a cholecystectomy), you may find that you have digestive problems. This organ stores bile produced by the liver, so not having one eliminates the regulation of the amount of bile that passes into the small intestines. This increased amount of bile can create more frequent, watery stools (which is why many patients of these patients consider taking this medication).
As mentioned earlier, this drug can also negatively impact your "sphincter of oddi" (SO), a valve located within the small intestine that regulates the flow of bile and pancreatic fluids. Taking this drug could relax this muscle causing fluids to back up into the pancreas which then starts to digest itself causing pancreatitis. This can lead to serious complications including hospitalization or death.
Unfortunately, pancreatitis has been reported with prolonged use of Viberzi and serious cases have occurred after only one or two doses. One death associated with pancreatitis was preceded by acute, severe abdominal pain, nausea and vomiting within 60 minutes of taking a single dose of this drug. The patient died three days later.
Due to these potentially fatal problems, Viberzi warns that patients should not take this medication if they:
As with any medication, it’s crucial to weigh the benefits with the potential risks. In clinical studies that measured the effects of Viberzi, 8% who were treated with 75 mg and 8% who were treated with 100mg had to discontinue use due to adverse reactions. Here are some serious conditions that you should be aware of:
Constipation - The most common reason why patients had to stop taking this drug in the clinical study was due to the uncomfortable effects of constipation. Approximately 50% of those who reported having constipation struggled with this condition within the first two weeks of treatment while the majority occurred within the first three months of therapy.
Abdominal Pain - Abdominal pain is one of the biggest concerns for patients who are considering taking this medication. According to eHealthMe.com and their study based on the FDA reports concerning Viberzi, they found that 85.48% of patients suffered from abdominal pain during the first month, 85.44% were female and 52.83% were over the age of 60 years old. “1,131 people reported to have side effects when taking Viberzi,” warns eHealthMe. “Among them, 216 people (19.1%) have abdominal pain.”
Drug Abuse - This medication is an opioid and can cause feelings of euphoria or being drunk. According to Drugs.com, “In two human abuse potential studies with Viberzi conducted in recreational opioid-experienced individuals, euphoria was reported at a rate of 14% to 28%. This data suggests that eluxadoline may produce psychological dependence.”
Pancreatitis With A Gallbladder - In a Safety Communication published by the FDA, “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.”Among the 68 patients who reported their gallbladder status, 12 DID have their gallbladder one. That means that at least 10% had a “serious case of pancreatitis.”
