Poor
Not Aligned
Patient Risk:
Low
Summary
Most statements about NSAID use, contraindications, monitoring, and drug interactions are not supported by the provided Cosentyx prescribing information excerpts. Several safety/interaction claims (e.g., GI bleeding risk with NSAIDs; kidney damage; blood pressure; assertions about “no contraindications”) are not addressed in the supplied label text.
Category Scores
Accurate Statements
Cosentyx (secukinumab) is a biologic medication used to treat plaque psoriasis.
Supported by label Section 1.1 (plaque psoriasis indication).
Cosentyx (secukinumab) is a biologic medication used to treat psoriatic arthritis.
Supported by label Section 1.2 (psoriatic arthritis indication).
Cosentyx (secukinumab) is a biologic medication used to treat ankylosing spondylitis.
Supported by label Section 1.3 (ankylosing spondylitis indication).
Cosentyx works by blocking the action of interleukin-17A (IL-17A).
The provided excerpts do not explicitly state IL-17A mechanism; however, no contradiction is present in the supplied text. (Mechanism is not verifiable from provided excerpts.)
Unsupported Statements
A study found that use of NSAIDs with biologic medications like Cosentyx did not significantly increase the risk of adverse events.
No study content or NSAID-with-biologics risk statement is provided in the supplied label excerpts.
Another study reported that combining NSAIDs and biologics may increase the risk of gastrointestinal bleeding.
No NSAID-related gastrointestinal bleeding risk is provided in the supplied label excerpts.
According to Cosentyx prescribing information, there are no contraindications for the use of NSAIDs with Cosentyx.
The provided label contraindications are limited to serious hypersensitivity to secukinumab/excipients; the excerpts do not discuss NSAIDs or state “no contraindications” for NSAID co-use.
The Cosentyx manufacturer recommends caution when using NSAIDs with biologic medications due to an increased risk of gastrointestinal bleeding.
No manufacturer recommendation about NSAIDs and GI bleeding appears in the supplied excerpts.
Patients taking Cosentyx with NSAIDs should be monitored closely for signs of gastrointestinal bleeding or other adverse events.
The supplied warnings do not specify monitoring for GI bleeding in the context of NSAID co-administration.
OTC NSAIDs can be taken with Cosentyx.
The supplied label excerpts do not address OTC NSAIDs or permit their use with Cosentyx.
OTC NSAIDs taken with Cosentyx should follow the recommended dosage and be discussed with a doctor beforehand.
No NSAID guidance is provided in the supplied label excerpts.
Prescription-strength NSAIDs (e.g., diclofenac and indomethacin) may be used with Cosentyx under the guidance of a healthcare professional.
The supplied label excerpts do not mention NSAIDs or specific NSAIDs.
When using prescription-strength NSAIDs with Cosentyx, patients should monitor their condition closely and report adverse events.
No NSAID co-use monitoring instructions are provided in the supplied label excerpts.
Cosentyx can interact with other medications, including antacids.
The supplied label drug interaction excerpt discusses CYP substrate monitoring but does not mention antacids.
Cosentyx can interact with other medications, including blood thinners.
The supplied label excerpts do not mention blood thinners.
Cosentyx can interact with other medications, including immunosuppressants.
The supplied label excerpts do not mention immunosuppressants.
While taking Cosentyx and NSAIDs, gastrointestinal bleeding is an adverse event that warrants seeking medical attention immediately.
The supplied label excerpts do not identify GI bleeding as a specific adverse event warranting immediate attention for NSAID co-use.
If gastrointestinal bleeding occurs while taking Cosentyx and NSAIDs, a doctor may need to adjust the treatment plan or discontinue one or both medications.
No label guidance is provided for adjusting/discontinuing Cosentyx or NSAIDs in response to GI bleeding.
Potential interaction risks between NSAIDs and biologics (including Cosentyx) include gastrointestinal bleeding.
No NSAID interaction risk for GI bleeding is included in the supplied label excerpts.
Potential interaction risks between NSAIDs and biologics (including Cosentyx) include kidney damage.
No kidney damage risk related to NSAIDs or biologics appears in the supplied label excerpts.
Potential interaction risks between NSAIDs and biologics (including Cosentyx) include increased blood pressure.
No increased blood pressure risk related to NSAIDs or biologics appears in the supplied label excerpts.
Patients with a history of gastrointestinal bleeding should consult a doctor before taking NSAIDs with Cosentyx.
The supplied label excerpts do not provide NSAID-specific counseling for patients with prior GI bleeding.
If a person experiences adverse events such as gastrointestinal bleeding while taking Cosentyx and NSAIDs, they should seek medical attention immediately.
No label excerpt supports immediate medical attention advice specifically for GI bleeding in the context of NSAID co-use.
Contradictions
Important Omissions
Cosentyx-specific warnings and precautions from the provided label (e.g., TB evaluation/treatment prior to initiation; infection risk; inflammatory bowel disease monitoring; live vaccine avoidance; hypersensitivity discontinuation) were not addressed in the AI claims.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
The primary patient-safety concern is informational: multiple claims about NSAID co-use risks and contraindication status are unsupported by the provided label excerpts and could mislead decision-making. The supplied excerpts do not directly provide these NSAID-related risks, so the mismatch is primarily about label alignment rather than direct contradiction.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Majority of NSAID co-administration, interaction, and GI bleeding/counseling claims are absent from the provided Cosentyx prescribing information excerpts and therefore cannot be validated against the label.
Suggested Improvement
Limit claims to label-supported content from Sections 1.1–1.3 (indications) and Sections 4–7 (contraindications, infections/TB/IBD and hypersensitivity precautions, and the label’s generalized drug interaction guidance). Remove or rephrase NSAID-specific GI bleeding/kidney/blood pressure interaction statements unless supported by provided label text.