Semaglutide official-source update · version 1

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Official-source update

Reviewed 2026-09-16 · Preserved version 1

FDA revisited the psychiatric-safety warning

On January 13, 2026, FDA requested removal of the suicidal-behavior and ideation warning from Wegovy labeling after its review found no increased risk. This records the agency’s request, not a claim that every label version has changed. FDA PDF pp. 1 ↗

More findings and the sources behind them

Selected FDA safety communications, read alongside the separately preserved product-label account and human evidence review.

What supported that finding

FDA combined 91 placebo-controlled trials involving 107,910 participants and examined a separate Sentinel claims cohort. These are class-wide analyses, not a dedicated trial of this peptide or a finding about every possible adverse effect. FDA PDF pp. 2, 3 ↗

The chemical form matters

FDA distinguishes semaglutide sodium and acetate from the active ingredient in approved drugs; it lacks information establishing the same chemical and pharmacologic properties. Evidence about an approved product should not be transferred automatically to those salts. FDA source ↗

What remains to be checked

Reconcile each current product and formulation label with subsequent safety and indication changes.
Appraise remaining eligible trial reports and follow-up studies; this update does not complete the literature review.

Source dates and review coverage

PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.

FDA January 2026 GLP-1 psychiatric-safety communication ↗
Source dated 2026-01-13; retrieved 2026-09-16.
- What Is FDA Doing? · PDF pp. 1 of 3
- What Did FDA Find? · PDF pp. 2, 3 of 3
SHA-256: d2cc0d43605a9300646146c86f0fd4b84611ada2272de7e65425f33fb7aae53c
FDA concerns with unapproved GLP-1 drugs ↗
Source dated 2026-09-01; retrieved 2026-09-16.
- Concerns with compounded versions of these drugs
- Salt forms should not be used to compound semaglutide
- Adverse events related to compounded versions of semaglutide and tirzepatide
- Retatrutide and cagrilintide cannot be used in compounding
SHA-256: bfb6cd2a11e3f8e20bedfeed0e0d554205c76dd83f473956deb82afc186e51cc

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