Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Several statements are supported (e.g., brand/generic, opioid nature, indication concept, Schedule II, CNS receptor mechanism, and many serious risks/side effects listed). However, multiple claims are unsupported or conflict with label-restricted details provided (notably: specific duration/“chronic and acute,” formulations for “injectable solutions,” and “AbbVie manufactures Dilaudid”).
Category Scores
Accurate Statements
Dilaudid is the brand name for hydromorphone.
11 DESCRIPTION: “DILAUDID (hydromorphone hydrochloride)”
Hydromorphone is a powerful opioid analgesic.
11 DESCRIPTION: “DILAUDID … is an opioid agonist.” (Powerful/analgesic wording not explicitly used in provided label text, but opioid agonist use for pain is consistent with indication text.)
Hydromorphone is used for managing moderate to severe pain.
1 INDICATIONS AND USAGE: “management of pain severe enough to require an opioid analgesic” (label uses “severe enough”; “moderate to” not supported).
Dilaudid is available in various formulations, including oral tablets.
3 DOSAGE FORMS AND STRENGTHS: “DILAUDID Tablets” and listed strengths for oral administration; 11 DESCRIPTION: tablets for oral administration.
Dilaudid is available in various formulations, including oral solution.
3 DOSAGE FORMS AND STRENGTHS: “DILAUDID Oral Solution” (5 mg/5 mL).
Hydromorphone is a Schedule II controlled substance.
9.1 Controlled Substance: “contain hydromorphone, a Schedule II controlled substance.”
Hydromorphone acts on the central nervous system by binding to opioid receptors.
No explicit receptor-binding statement is present in the provided label excerpts.
Binding to opioid receptors alters the body's perception of pain.
No explicit statement about perception of pain or receptor-binding effects is present in the provided label excerpts.
Dilaudid carries significant risks including the potential for addiction.
1 INDICATIONS AND USAGE: “risks of addiction, abuse, misuse, overdose, and death …”
Dilaudid carries significant risks including the potential for abuse.
1 INDICATIONS AND USAGE: “risks of addiction, abuse, misuse, overdose, and death …”
Dilaudid carries significant risks including the potential for overdose.
1 INDICATIONS AND USAGE: “risks of addiction, abuse, misuse, overdose, and death …” and 9.2 Abuse: “risk of overdose and death.”
Respiratory depression is a primary concern with Dilaudid.
6 ADVERSE REACTIONS list includes “Life-Threatening Respiratory Depression.”
Respiratory depression with Dilaudid can be fatal.
6 ADVERSE REACTIONS: “Life-Threatening Respiratory Depression” (fatality explicitly stated in provided excerpts is not confirmed, but “life-threatening” is present).
Dilaudid side effects can include constipation.
No specific “constipation” adverse reaction is provided in the excerpts (6 ADVERSE REACTIONS section content included only the serious adverse reactions list; constipation not shown).
Unsupported Statements
Hydromorphone is used for managing moderate to severe pain.
Label excerpt uses “pain severe enough to require an opioid analgesic”; “moderate to” is not supported.
Dilaudid is prescribed for the short-term and long-term management of chronic and acute pain.
No provided label text states short-term vs long-term, or chronic vs acute management.
Dilaudid is used for pain levels that do not respond to less potent analgesics.
Label excerpt supports “reserve… for use… alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate,” but does not specifically mention “less potent analgesics” or “pain levels that do not respond.”
Dilaudid is available in various formulations, including injectable solutions.
9.2 Abuse: “DILAUDID Oral Solution and DILAUDID Tablets are approved for oral use only.” No injectable formulation is supported in the provided label text.
AbbVie manufactures Dilaudid.
No manufacturer information (e.g., AbbVie) is present in the provided label excerpts.
Hydromorphone acts on the central nervous system by binding to opioid receptors.
No receptor-binding mechanism is stated in the provided label excerpts.
Binding to opioid receptors alters the body's perception of pain.
No statement about perception of pain is present in the provided label excerpts.
Dilaudid side effects can include dizziness.
No “dizziness” adverse reaction is present in the provided label excerpts.
Dilaudid side effects can include drowsiness.
No “drowsiness” adverse reaction is present in the provided label excerpts.
Dilaudid side effects can include nausea.
No “nausea” adverse reaction is present in the provided label excerpts.
Dilaudid side effects can include constipation.
No “constipation” adverse reaction is present in the provided label excerpts.
Contradictions
High
AI Statement
Dilaudid is available in various formulations, including injectable solutions.
Label Reference
9.2 Abuse: “DILAUDID Oral Solution and DILAUDID Tablets are approved for oral use only.”
Important Omissions
For the indication statement: label includes explicit limitation language reserving opioid analgesics for patients where alternative options are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Importance:
Moderate
For safety-related claims: label lists specific serious risks (e.g., addiction/abuse/misuse, life-threatening respiratory depression, benzodiazepine/CNS depressant interactions, neonatal opioid withdrawal syndrome, opioid-induced hyperalgesia/allodynia, adrenal insufficiency, severe hypotension, GI adverse reactions, seizures, withdrawal). The response does not reflect these specifics beyond respiratory depression and addiction/abuse/overdose.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
A contradictory claim about injectable formulations (while label states oral-only approval) could materially mislead administration route. Several other adverse-effect claims are unsupported because specific side effects (dizziness, drowsiness, nausea, constipation) are not present in provided excerpts.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Includes an on-label contradiction (injectable solutions) and multiple unsupported mechanistic/side-effect/manufacturer claims not present in supplied label excerpts.
Suggested Improvement
Remove injectable formulation claim or specify label-supported oral-only formulations; restrict mechanism/side-effect/facility-manufacturer statements to what is actually present in the provided label text; align indication wording with “severe enough… alternative treatments are inadequate/ineffective/not tolerated/otherwise inadequate” from Indications and Usage.