Our request
We ask FDA to strengthen and publish adverse-event surveillance relevant to compounded and take-home ketamine, building on the agency's October 2023 safety communication.
Where the available reporting systems and data permit, please report psychiatric outcomes and urologic outcomes separately and describe the product context, route of access, and care setting in ways consistent with privacy protections and reliable classification.
Please explain how reports are collected and assessed, what information is missing, how duplicate or incomplete reports are handled, and what conclusions cannot be drawn from spontaneous adverse-event reports. A public summary of methods and updates would help readers interpret the evidence responsibly.
Why it matters
The supplied research plan treats possible growth in take-home or telehealth-prescribed use as a hypothesis and notes that current data cannot allocate observed changes to a particular setting.
More transparent adverse-event surveillance could help characterize reports and gaps. Reports alone do not establish incidence, comparative risk, or causation.
What good reporting looks like
- Build on the agency's existing safety communication and avoid implying that reported events represent all users.
- Keep psychiatric and urologic outcomes distinct in summaries.
- Describe reporting limitations, including missing exposure details and the absence of a denominator where applicable.