Guidance Document for Claims Relating to Drug Interactions

Non-comparative claims for drug interactions require balance. We offer the following guidance:

Balancing information should be part of the body copy.

With respect to comparative drug interactions presentations, detailed and complete drug interaction information for all compared products is required for a fair and complete presentation.

Examples of acceptable presentations based on the attached mock Product Monograph for ARBACE

Specific claim relating to sertraline:

ARBACE does not interact with sertraline.

Concentrations of other selective serotonin reuptake inhibitors (SSRIs) may be increased when coadministered with ARBACE. Dose titration may be required for most drugs of the SSRI class and dose reduction should be considered when trazodone is coadministered with ARBACE.

Please see the Product Monograph for contraindications with ergot derivatives (dihydroergotamine, ergonovine, ergotamine), serious interactions with carbamazepine, phenobarbital and phenytoin, and interactions with colchicine, lovastatin, simvastatin, perphenazine and pimozide.

General claim:

Good drug-drug interaction profile.

Please see the Product Monograph for contraindications with ergot derivatives (dihydroergotamine, ergonovine, ergotamine), serious interactions with carbamazepine, phenobarbital and phenytoin, and interactions with SSRIs, trazodone, colchicine, lovastatin, simvastatin, perphenazine and pimozide.

Guidance Document for Claims Relating to Drug Interactions

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