Partial
Partially Aligned
Patient Risk:
Medium
Summary
Many statements appear to mix oxymorphone extended-release (ER) concepts with OPANA (oxymorphone immediate-release) label excerpts, and several safety/dosing/details are not supported by the provided OPANA label text. Some general opioid/respiratory-depression concepts align, but multiple claims are unsupported or potentially mismatched to the IR label.
Category Scores
Accurate Statements
The most serious risk of oxymorphone ER is slowed or stopped breathing (respiratory depression).
OPANA label excerpt (5.1 Respiratory Depression): Respiratory depression is the chief hazard of OPANA.
The risk of respiratory depression with oxymorphone ER is higher when combined with other depressants.
OPANA label excerpt (5.3 Additive CNS Depressant Effects and 7.1 Use with CNS Depressants): concomitant use of other CNS depressants with oxymorphone may produce increased depressant effects including hypoventilation... coma and death; should be started at 1/3 to 1/2 due to respiratory depression...
Key risks of oxymorphone include opioid dependence and withdrawal.
OPANA label excerpt (9.3 Dependence): Opioid analgesics may cause physical dependence... withdrawal symptoms after abrupt discontinuation.
Key risks of oxymorphone include overdose.
OPANA label excerpt (5.2 Misuse, Abuse, and Diversion): could result in overdose and death.
Key risks of oxymorphone include dangerous breathing problems.
OPANA label excerpt (5.1 Respiratory Depression): respiratory depression may occur... chief hazard.
Unsupported Statements
Oxymorphone HCl ER is formulated to release oxymorphone slowly over time.
Provided label excerpts are for OPANA (oxymorphone immediate-release) and do not support ER formulation-release mechanism.
Oxymorphone HCl ER is used to manage chronic, around-the-clock pain.
OPANA (IR) label excerpt provided indicates moderate to severe acute pain where use of an opioid is appropriate; chronic around-the-clock pain use is not supported by the provided excerpt.
Oxymorphone HCl ER is used for chronic pain that requires daily, long-term opioid treatment.
Not supported by the provided OPANA indication excerpt.
Oxymorphone HCl ER is used when chronic pain cannot be adequately managed with other pain medicines.
Not supported by the provided OPANA indication excerpt.
Oxymorphone acts on opioid receptors in the brain and spinal cord to reduce pain signaling.
No such mechanism statement is supported by the provided OPANA excerpts.
Oxymorphone ER is designed to maintain steadier blood levels during the day.
No ER pharmacokinetic/steady-level claim is supported by the provided OPANA (IR) excerpts.
Oxymorphone ER produces steadier blood levels rather than a fast peak like immediate-release products.
Not supported by the provided OPANA (IR) excerpts; also pertains to ER vs IR PK comparisons not present.
Extended-release oxymorphone must be swallowed whole.
No ER tablet swallowing-whole instruction is supported by the provided OPANA (IR) label excerpts.
Crushing, chewing, or breaking an ER tablet can cause the medicine to release too quickly.
No ER tablet manipulation/release-rate statement is supported by the provided OPANA (IR) excerpts.
Crushing, chewing, or breaking an ER tablet increases the risk of overdose and other serious side effects.
Label excerpt provided mentions abuse of OPANA tablets by crushing/chewing/snorting/injecting leading to overdose and death, but the specific ER-tablet release-too-quick and ER-specific manipulation risk is not supported.
Combining oxymorphone ER with other sedating drugs or alcohol can increase the risk of opioid-related respiratory depression unless a clinician specifically approves it.
OPANA label excerpt supports additive CNS depressant effects with sedatives/hypnotics and alcohol, and need to start at reduced dose/consider reducing one or both agents; the conditional phrasing 'unless a clinician specifically approves it' is not supported.
Common side effects of oxymorphone ER include sleepiness.
OPANA common adverse reactions include Somnolence; however, the claim is ER-specific and uses non-label wording. The excerpt does support somnolence as a common adverse reaction, but ER-specific framing is unsupported by provided IR label excerpts.
Common side effects of oxymorphone ER include dizziness.
OPANA label excerpt lists dizziness as a common adverse reaction, but claim is ER-specific; ER specificity is not supported by the provided excerpt.
Common side effects of oxymorphone ER include nausea/vomiting.
OPANA label excerpt lists nausea and vomiting as common adverse reactions; ER-specific framing is not supported.
Common side effects of oxymorphone ER include constipation.
OPANA label excerpt lists constipation as common; ER-specific framing is not supported.
Common side effects of oxymorphone ER include itching.
OPANA label excerpt lists pruritus; claim uses 'itching' which is consistent with pruritus, but ER-specific framing is not supported.
The risk of respiratory depression with oxymorphone ER is higher at higher doses.
The provided OPANA excerpts emphasize respiratory depression and increased frequency in elderly/debilitated and conditions with hypoxia/hypercapnia, but do not explicitly state dose-dependent higher-risk phrasing.
Extra caution with oxymorphone is needed for people with breathing disorders such as sleep apnea or COPD.
OPANA label excerpt includes sleep apnea syndrome and COPD/cor pulmonale in hypoxia/hypercapnia/decreased respiratory reserve list; however, 'extra caution needed' language is not exact but is generally consistent. Rated as unsupported due to not being an exact labeled caution phrase? (Potential overlap—see warnings score).
Extra caution with oxymorphone is needed for older adults.
OPANA label excerpt (5.1 Respiratory Depression) notes respiratory depression may occur more frequently in elderly or debilitated patients; the claim is generally consistent but not specifically phrased as 'extra caution needed for older adults' in the excerpt.
Extra caution with oxymorphone is needed for people with liver problems.
OPANA label excerpt provides contraindication in moderate/severe hepatic impairment and caution in mild hepatic impairment; the claim is broad ('liver problems') and not supported as stated.
Clinicians consider drug interactions that can increase sedation or opioid levels.
Provided OPANA excerpts address additive CNS depressant effects and MAOI restriction, but do not support the broader claim about 'increase... opioid levels.'
Contradictions
Low
AI Statement
Oxymorphone HCl ER is used to manage chronic, around-the-clock pain.
Label Reference
Contradiction with provided OPANA indication excerpt: OPANA is indicated for relief of moderate to severe acute pain where use of an opioid is appropriate.
Important Omissions
For OPANA (IR): empty-stomach administration timing (at least 1 hour prior to or 2 hours after eating) and patient selection/individualization, initiation dosing ranges, and tapering guidance are not mentioned in the provided AI statements.
Importance:
Moderate
For OPANA (IR): specific contraindications (e.g., acute/severe bronchial asthma or hypercarbia, suspected paralytic ileus, respiratory depression except monitored/resuscitative equipment, moderate/severe hepatic impairment) and MAOI 'within 14 days' restriction are not reflected in the AI statements.
Importance:
Moderate
For OPANA (IR): renal impairment guidance (caution and reduced dosages when creatinine clearance <50 mL/min) is omitted from the provided AI statements.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Medium
Mismatch between ER-focused statements and provided OPANA (IR) label excerpts plus unsupported/differently framed details could lead to inaccurate label alignment. Some core respiratory-depression and CNS-depressant interaction concepts are consistent, but multiple omissions and ER/IR framing errors remain.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Claims appear to conflate oxymorphone extended-release (ER) product information with OPANA (oxymorphone immediate-release) label excerpts, and several statements are not supported by the provided label text.
Suggested Improvement
Evaluate each claim specifically against OPANA (IR) label sections provided: align indications (acute pain), remove/avoid ER-specific administration/formulation and PK steadier-level statements, and replace broad interaction/safety wording with the exact label-supported guidance (CNS depressants dose reduction; MAOI within 14 days; contraindications; renal/hepatic impairment cautions).