The warning is on the label; the page is gone
Every antidepressant label carries a boxed warning about suicidal thoughts. The FDA page that explained how it got there returns 404, and so does the whole section around it.
We have not finished checking this source. No judgement either way. how we score evidence
Caveat on this rating: The 2003-2007 chronology behind this warning is DELIBERATELY ABSENT from this row. The October 2003 advisory, the October 2004 announcement, the 2005 label change and the 2007 extension to adults under 25 could not be confirmed against a primary source during verification, so not one of those dates is stated. What is stated is what was verified: the boxed warning's current wording, read off the live label, and the fact that the FDA pages that explained it now 404. An unverified date on a row about a documentary record would be the exact failure this trail is about.
Open any antidepressant label today and the boxed warning is there. The FDA page that explained how that warning came about is gone.
Significant findings
The warning is not subtle. This is the current label, word for word.
"Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies."
The same paragraph gives the boundary. No increase was seen in patients over age 24, and risk was reduced in patients aged 65 and older.
The FDA's own page on this returns 404. So does the entire section it sat in.
An archive capture from August 2019 shows that page working normally. After that there are copies, and no original.
Worth asking
The warning still applies and still matters. Read it on the label, which is current, public and easy to find.
For the reasoning behind it, ask your prescriber rather than hunting a federal page that is no longer there. Never stop an antidepressant abruptly: any change belongs in a prescriber conversation with a taper plan.
Source
PROZAC (fluoxetine hydrochloride) capsule - prescribing information — Dista Products Company (2026)
How this was scored
- Study design
- not recorded
- Funding
- not recorded
- Published in
- not recorded
- Sample size
- not recorded
- Preregistered
- not recorded
- Conflicts disclosed
- not recorded
- Independent of proponent
- not recorded
- Retracted
- No
We have not finished checking this source, so there is no scoring to show yet. “We have not checked this yet” and “this is disputed” are different statements, so no scored band is shown rather than a low one.
Read the full scoring rubric, including what it can't tell you.
Published August 31, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "not yet assessed". We have not finished checking this source. No judgement either way. One caveat travels with that badge: The 2003-2007 chronology behind this warning is DELIBERATELY ABSENT from this row. The October 2003 advisory, the October 2004 announcement, the 2005 label change and the 2007 extension to adults under 25 could not be confirmed against a primary source during verification, so not one of those dates is stated. What is stated is what was verified: the boxed warning's current wording, read off the live label, and the fact that the FDA pages that explained it now 404. An unverified date on a row about a documentary record would be the exact failure this trail is about. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
PROZAC (fluoxetine hydrochloride) capsule - prescribing information — Dista Products Company (2026). The full source is linked on this page so you can read it yourself.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.