Poor
Not Aligned
Patient Risk:
High
Summary
Most claims are not supported by the provided COSENTYX label excerpts. Several (e.g., acetaminophen/aspirin/NSAID, antihistamines, corticosteroids adrenal insufficiency, bleeding case report, and aspirin-related bleeding risk stratified by bleeding disorder history) are absent from the supplied label text, and the IL-17A mechanism is only indirectly supported.
Category Scores
Accurate Statements
Cosentyx (secukinumab) blocks the action of interleukin-17A (IL-17A).
Supported indirectly by label Description/Mechanism excerpt: “Secukinumab… interleukin-17A antagonist.” (Label section 11 DESCRIPTION / IL-17A antagonist statement).
Unsupported Statements
High doses of acetaminophen taken with Cosentyx can increase the risk of liver damage.
No acetaminophen or liver damage interaction/safety statement appears in the provided label excerpts.
A high dose of acetaminophen (more than 2 grams per day) while on Cosentyx is associated with a higher risk of liver damage.
No threshold dose (e.g., >2 g/day) and no acetaminophen/liver damage association is present in the provided label excerpts.
Aspirin taken with Cosentyx can increase the risk of bleeding.
No aspirin or bleeding risk interaction statement appears in the provided label excerpts.
The risk of bleeding with aspirin taken with Cosentyx is higher in patients with a history of bleeding disorders.
No bleeding-disorder risk stratification for aspirin/Cosentyx is present in the provided label excerpts.
NSAIDs taken with Cosentyx can increase the risk of bleeding.
No NSAID/bleeding interaction statement appears in the provided label excerpts.
NSAIDs taken with Cosentyx can increase the risk of kidney damage.
No NSAID/kidney damage interaction statement appears in the provided label excerpts.
Antihistamines (e.g., diphenhydramine) taken with Cosentyx can increase the risk of drowsiness.
No antihistamine/diphenhydramine interaction or drowsiness statement appears in the provided label excerpts.
Antihistamines (e.g., diphenhydramine) taken with Cosentyx can increase the risk of dizziness.
No antihistamine/diphenhydramine interaction or dizziness statement appears in the provided label excerpts.
Corticosteroids taken with Cosentyx can increase the risk of adrenal insufficiency.
No corticosteroid/adrenal insufficiency interaction or risk statement appears in the provided label excerpts.
A case report described severe bleeding in a patient taking aspirin and Cosentyx.
No postmarketing case report or severe bleeding event involving aspirin plus Cosentyx is present in the provided label excerpts.
Contradictions
Important Omissions
If the intent was to assess Cosentyx’s actual drug interaction warnings beyond “CYP450 substrates” monitoring/possible dosage adjustment, the provided excerpts do not include specific interaction guidance for acetaminophen, aspirin, NSAIDs, antihistamines, or corticosteroids; the response did not limit claims to what is present in the label excerpts.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
High
Multiple medication-specific safety/interaction claims (acetaminophen/hepatotoxicity, aspirin/NSAID bleeding, NSAID kidney damage, antihistamine CNS effects, corticosteroid adrenal insufficiency, and a severe bleeding case report) are not supported by the provided label excerpts. Unfounded interaction risk claims could mislead clinical decision-making.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Many claims are absent from the provided COSENTYX prescribing information excerpts; only the IL-17A antagonism mechanism is supported (indirectly).
Suggested Improvement
Restrict claims to label-supported information from the provided excerpts (e.g., IL-17A antagonist mechanism; infection/IBD/immunization/hypersensitivity warnings; CYP450-substrate monitoring concept) and remove drug-specific interaction and dose-threshold liver/bleeding/kidney/CNS/adrenal insufficiency assertions that are not present in the provided label text.