Summary
Unable to perform on-label alignment evaluation because the provided label excerpts do not include a complete mapping for all claims as presented; additionally, several mechanistic/endpoint and approval-timing statements are not supported by the supplied excerpt set. Most claims cannot be confirmed against the provided label text.
Category Scores
Accurate Statements
Eluxadoline (Viberzi) is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
Indications and Usage: "VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D)."
Eluxadoline is an oral medication.
Dosage Forms and Strengths: "75 mg tablets" and "100 mg tablets"; Patient counseling: "take one tablet twice daily with food." (oral tablets implied by label excerpts)
Eluxadoline has intended peripheral action to limit central nervous system effects.
Eluxadoline is a mixed mu-opioid receptor agonist and delta-opioid receptor antagonist.
Clinical Pharmacology (12.1): "Eluxadoline is a mu-opioid receptor agonist; eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist."
Unsupported Statements
Eluxadoline works by targeting opioid receptors in the gut.
No supplied excerpt explicitly states location of opioid receptors in the gut.
Eluxadoline reduces intestinal motility and secretion.
No supplied excerpt includes effects on intestinal motility and secretion.
Eluxadoline alleviates diarrhea and abdominal pain associated with IBS-D.
The provided excerpts mention indication for IBS-D but do not explicitly state diarrhea/abdominal pain alleviation as mechanisms or endpoints.
Eluxadoline has intended peripheral action to limit central nervous system effects.
No supplied excerpt addresses peripheral vs central nervous system effects.
Eluxadoline interacts with opioid receptors predominantly located in the enteric nervous system of the gastrointestinal tract.
No supplied excerpt specifies predominant receptor location in the enteric nervous system.
As a mu-opioid receptor agonist, eluxadoline decreases gastrointestinal motility and reduces visceral sensitivity.
No supplied excerpt connects mu-opioid agonism to motility/visceral sensitivity outcomes.
Eluxadoline’s delta-opioid receptor antagonist activity is thought to mitigate opioid-induced constipation, a common side effect with mu-opioid agonists.
No supplied excerpt describes delta antagonism as a mitigation rationale for constipation or references opioid-induced constipation as a general concept.
The FDA approved Viberzi for the treatment of IBS-D in adults in November 2015.
No supplied excerpt contains approval date.
Common side effects of Viberzi include constipation, nausea, and abdominal pain.
The provided label excerpts only explicitly state constipation was the most commonly reported adverse reaction; nausea and abdominal pain are not supported by the supplied excerpts.
Serious risks of Viberzi include pancreatitis.
Although pancreatitis is described as a warning, calling it a 'serious risk' and 'include' is not directly stated as such in the excerpt; however pancreatitis is clearly a warning. This item is treated as partially supported but not fully evidenced by the excerpt wording.
Serious risks of Viberzi include sphincter of Oddi dysfunction.
The excerpt describes 'sphincter of Oddi spasm' and risk; it does not use the term 'dysfunction.'
The risk of pancreatitis and sphincter of Oddi dysfunction is particularly in patients who have had their gallbladder removed.
The excerpt states cases occurred primarily in patients without a gallbladder; it does not use 'particularly' or 'dysfunction' phrasing.
Contradictions
Low
AI Statement
Viberzi is not approved for or recommended for individuals with irritable bowel syndrome with constipation (IBS-C).
Label Reference
No supplied excerpt addresses IBS-C or IBS-M indications/recommendations.
Low
AI Statement
Viberzi is not approved for or recommended for individuals with mixed irritable bowel syndrome (IBS-M).
Label Reference
No supplied excerpt addresses IBS-C or IBS-M indications/recommendations.
Low
AI Statement
Viberzi is manufactured by AbbVie Inc.
Label Reference
No supplied excerpt includes manufacturer/label holder information.
Important Omissions
Dose and administration specifics (e.g., recommended dose 100 mg twice daily with food; 75 mg twice daily in specified patients; instructions for missed doses).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The response includes several safety-relevant claims (pancreatitis, sphincter of Oddi spasm risk without gallbladder, and contraindication for without gallbladder and history of pancreatitis, plus hepatic impairment contraindication). Some mechanistic/endpoint and side-effect frequency claims are unsupported by the provided excerpts, but direct contraindication/warning elements are largely consistent with the supplied label text.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Mostly Aligned
Primary Issue
Multiple mechanistic, timing (approval date), side-effect composition, receptor-location, and IBS-C/IBS-M statements are not supported or not evidenced by the provided label excerpts.
Suggested Improvement
Restrict claims to information explicitly present in the supplied label excerpts (e.g., indication, oral tablet dosing, contraindications without gallbladder and history of pancreatitis, severe hepatic impairment Child-Pugh C contraindication, and warnings about pancreatitis and sphincter of Oddi spasm primarily in patients without a gallbladder). Remove or qualify unsupported mechanistic/receptor-location and approval-date/unsourced manufacturing statements; avoid stating non-indications (IBS-C/IBS-M) unless supported by the label excerpts provided.