664 - In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated...
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continued ... in the xxx development program." Please advice if my assumption is correct. Thank you.
Response: A definitive answer cannot be provided without consideration of the complete TMA in the context of the relevant area. There are times when the absence of information is an important factor in rational product selection. For example, disclosure of this absence of information is more important when there is reason to believe that the product may cause motor or cognitive impairment (e.g. say the pharmacodynamics section of the PM speaks to molecular interactions with a receptor implicated with motor or cognitive impairment, or say the product shares the same mechanism as other products in it's pharmacologic class known to cause motor and cognitive impairment). On the other hand, there's little reason to require inclusion in fair balance if the topic is included in the TMA merely for consistency with the standard monograph template.
