The mission of the Food and Drug Administration (FDA) is simple – it is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. And we for one are glad they exist as you will shortly surely agree.
Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration on Wednesday warned about the increased risk of serious pancreatitis in such patients.
For those who are unaware, irritable bowel syndrome (IBS) is a common disorder that affects the large intestine (colon). Irritable bowel syndrome commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. IBS is a chronic condition that you will need to manage long term. However, when a person takes medication for one ailment, they surely don’t want it to cause another, as is the case here.
From May 2015, when Viberzi was first approved, through February 2017, FDA says it received 120 reports of serious cases of pancreatitis or death.
“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 3 days of taking the initial Viberzi dose,” FDA said.
“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,” FDA said. “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.”
Although doctors have been told to be more diligent prescribing this medication, it is only through public awareness that we can further inform the public as to the danger at hand. If you, or someone you know is taking Viberzi, it is imperative that you speak to your healthcare professional as soon as possible.