Patients who took Viberzi (eluxadoline) to help control the symptoms of irritable bowel syndrome (IBS) and then suffered hospitalization because of pancreatitis may be able to recover damages in court.
On March 15, 2017, the FDA warned about a possible connection between Viberzi, manufactured by Allergan, and pancreatitis. They advised patients to be aware of symptoms like worsening abdominal pain, pain in the upper right side of the stomach or abdomen that may move into the back or shoulder, and nausea and vomiting. These could be signs of pancreatitis related to Viberzi.
The lawyers at Chaffin Luhana are currently investigating cases in which Viberzi caused dangerous side effects.
What is Irritable Bowel Syndrome (IBS)?
IBS is a digestive disorder that causes uncomfortable symptoms like abdominal pain, nausea and vomiting, cramping, bloating, diarrhea, and constipation. Patients are said to have an “oversensitive” colon or large intestine that overreacts to certain triggers. These triggers may include the following:
- Certain foods, like spices, chocolate, fats, beans, cabbage, milk, carbonated beverages, and more.
- Hormonal changes, such as those that occur during a woman’s menstrual period.
- Stressful occasions, such as public speaking, starting a new job, moving, or facing a nerve-wracking social situation.
- Illnesses, such as infectious diarrhea, bacterial overgrowth in the intestines, or other digestive illnesses.
- Anxiety and depression in some individuals can increase the risk of IBS, and flare-ups may trigger symptoms.
IBS can affect both men and women, but it is more common in women, and also seems to have a hereditary factor. In most cases, it does no damage to the intestinal tissues, but it is a chronic condition that can seriously affect the quality of life.
Researchers aren’t sure what causes IBS, but they believe it has something to do with how the brain, gut, and nerves communicate with each other. In patients with the disorder, something seems to go wrong with this communication, which affects the muscles in the digestive tract. They either move too slowly or too quickly, creating symptoms.
How Does Viberzi Work?
Viberzi is a prescription medication approved in May 2015 for the treatment of IBS. It is the first such medication produced by global pharmaceutical company Allergan, and is advertised by the company as relieving the core symptoms of IBS, including diarrhea and abdominal pain.
The drug contains an active ingredient that affects opioid receptors in the digestive tract, helping to even out the muscle contractions and reduce symptoms. Viberzi activates two of these receptors (mu and kappa), and inhibits one of them (Delta), which reduces the number of bowel contractions. The result is less diarrhea without increasing risk of constipation.
In the clinical trials used to achieve FDA approval, Viberzi was more effective than placebo in helping reduce abdominal pain and improve stool consistency over a 26-week period. There was, however, a slight risk of sphincter of Oddi spasm, resulting in pancreatitis or hepatic enzyme elevation. The manufacturer noted that patients without a gallbladder were at increased risk for this side effect.
There was also a “potential” increased risk of pancreatitis not associated with sphincter of Oddi spasms, but the majority of these, according to the manufacturer, were associated with excessive alcohol intake.
Viberzi Linked with Increased Risk of Pancreatitis
That risk for sphincter of Oddi spasm and pancreatitis may prove to be greater than the initial clinical trials indicated. The FDA warned in March 2017 that between May 2015, when Viberzi was approved, and February 2017, they received 120 reports of serious cases of pancreatitis or death related to the use of the drug. In 76 of these cases, the patients were hospitalized. Two of those patients died.
Though not all of the patients revealed their gallbladder status, 68 of them did. Analysis of the data revealed that in 56 of these cases, the patients did not have a gallbladder. Most of these patients received the recommended dose for patients without a gallbladder. (The prescribing information for the drug includes a recommendation of 75 mg twice daily with food for these patients.) Twenty-one of these cases reported that the patient did not abuse alcohol, and 35 didn’t report the patient’s alcohol use.
Not all of the patients reported when their symptoms started, but 84 of them did. Out of those, 48 suffered serious pancreatitis or death after taking just one or two doses of the drug. Serious cases were also reported with prolonged use.
In the two deaths that occurred, the following was found:
- One death was associated with pancreatitis. The patient suffered from acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi.
- One death was associated with sphincter of Oddi spasm. The patient reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi.
Both patients were hospitalized for their conditions, but did not survive. The FDA has advised healthcare providers not to prescribe Viberzi in patients without a gallbladder, and to consider other treatment options instead.
How Viberzi Causes Pancreatitis and Sphincter of Oddi Spasm
Viberzi can cause problems in two ways:
- by directly affecting the pancreas,
- or by affecting the sphincter of Oddi, and indirectly affecting the pancreas.
Pancreatitis is an inflammation of the pancreas, which is the gland that produces insulin. Insulin is the hormone the body uses to processes sugar from food and to transfer it to energy or fat storage. It also helps control blood sugar levels. It’s unclear exactly how Viberzi may cause pancreatitis, but it is believed that it has something to do with the way it slows down muscle contractions.
The sphincter of Oddi is a round valve, made up of muscular tissue, that surrounds the duct that controls the opening into the small intestine. Both bile and pancreatic juices flow through this duct into the small intestine. Normally, the valve controls the flow of these fluids, but in rare cases, it can go into a spasm, where it clamps shut and cannot relax open again.
When this happens, digestive juices, bile, and other fluids back up into the gallbladder, the pancreas and into the bile ducts of the liver. In people without a gallbladder, they go directly to the pancreas, where digestive enzymes can cause inflammation. Symptoms include stomach pain, pain in the upper belly that moves into the right shoulder, nausea, vomiting, fever, chills, and diarrhea.
People who have had their gallbladder removed are most at risk for sphincter of Oddi spasm. Now, it seems that Viberzi, because of how it slows muscle contracts, may negatively affect the valve muscle that is the sphincter of Oddi, causing it to clamp down. Treatment may involve medication to relax the sphincter of Oddi, or surgery to actually cut open the valve. Surgical treatment is difficult and carries a high risk of complications.
Types of Side Effects Associated with Viberzi
Viberzi has been associated with the following side effects:
- Abdominal pain
- Pancreatitis (in patients without a gallbladder)
- Sphincter of Oddi spasm (in patients without a gallbladder)
- Further complications requiring longer hospital stays
Viberzi Pancreatitis Lawsuits
The attorneys at Chaffin Luhana are actively investigating potential Viberzi pancreatitis lawsuits. Patients who have taken this medication and then experienced pancreatitis or sphincter of Oddi spasm may be able to recover damages in a Viberzi pancreatitis lawsuit.
Patients who suffered from pancreatitis may not have been aware of the possible connection with Viberzi. If you or a loved one have IBS and take this medication, you may be at risk for this condition, particularly if you have had your gallbladder removed.
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