Adverse Ketamine Report

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

1. Submitted adverse event report "of a patient who experienced respiratory depression after taking compounded oral ketamine outside of a health care setting for the treatment of PTSD" submitted in April 2023, referenced in this October 10, 2023, FDA guidance. (https://www.fda.gov/drugs/human-drug-compounding/fda-warns-patients-and-health-care-providers-about-potential-risks-associated-compounded-ketamine)

2. All digital communications between individuals involved in handling the above mentioned April 2023 adverse event report, including communication related to receiving, drafting and publication of the October 10, 2023, FDA guidance on ketamine, including but not limited to email, text messages, pdf, word processing, excel, and slide documents that mention the April 2023 adverse event report. Please include attachments.

3. All adverse event reports relating to ketamine for the treatment of a psychiatric disorder beginning in Jan 2020, until the time this request is processed.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Patrick McConnell