vida: extract claims from 2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026

- Source: inbox/queue/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md
- Domain: health
- Claims: 0, Entities: 1
- Enrichments: 3
- Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5)

Pentagon-Agent: Vida <PIPELINE>

domains/health/glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific.md

@@ -11,7 +11,7 @@ sourced_from: health/2025-xx-vigibase-glp1-psychiatric-adverse-events-eating-dis
 scope: causal
 sourcer: Clinical Nutrition / VigiBase WHO
 supports: ["glp1-discontinuation-predicted-by-psychiatric-comorbidity-creating-access-adherence-trap", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required"]
-related: ["glp1-eating-disorder-risk-subtype-specific-protective-bed-harmful-restrictive", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required", "glp1-psychiatric-effects-directionally-opposite-metabolic-versus-psychiatric-populations", "glp1-receptor-agonists-demonstrate-superior-efficacy-for-alcohol-use-disorder-in-comorbid-obesity-population", "semaglutide-reduces-depression-worsening-44-percent-in-diagnosed-patients-through-glp1r-psychiatric-mechanism", "glp1-anorexia-nervosa-evidence-absent-despite-pharmacovigilance-signal"]
+related: ["glp1-eating-disorder-risk-subtype-specific-protective-bed-harmful-restrictive", "glp1-pre-treatment-eating-disorder-screening-recommended-not-required", "glp1-psychiatric-effects-directionally-opposite-metabolic-versus-psychiatric-populations", "glp1-receptor-agonists-demonstrate-superior-efficacy-for-alcohol-use-disorder-in-comorbid-obesity-population", "semaglutide-reduces-depression-worsening-44-percent-in-diagnosed-patients-through-glp1r-psychiatric-mechanism", "glp1-anorexia-nervosa-evidence-absent-despite-pharmacovigilance-signal", "glp1-eating-disorder-pharmacovigilance-signal-class-effect-obesity-population-specific", "who-glp1-guideline-omits-eating-disorder-screening-despite-pharmacovigilance-signal"]
 ---
 
 # GLP-1 eating disorder pharmacovigilance signal (aROR 4.17-6.80) is a class effect that emerged specifically in the obesity treatment population after June 2021, not in the prior metabolic population
@@ -38,3 +38,10 @@ Methodological discrepancy between studies reveals sensitivity of signal detecti
 **Source:** PMC DAEN analysis, Australia 2025
 
 Australian DAEN database shows exceptionally high ROR (17.66) for dulaglutide eating disorder reports compared to US/Canadian databases, suggesting either: (1) small denominator effects in lower-volume database, (2) population-specific differences in drug response or reporting patterns, or (3) higher clinical awareness/reporting rates in Australian healthcare system. This geographic heterogeneity in signal strength warrants investigation of population-level moderators.
+
+
+## Extending Evidence
+
+**Source:** FDA Wegovy oral approval label, January 2026
+
+FDA oral Wegovy label (January 2026) contains NO eating disorder warning despite known pharmacovigilance signal (aROR 4.17-6.80). Label includes standard thyroid C-cell tumor boxed warning but explicitly REMOVED suicidal behavior/ideation warning in 2026 review after finding no causal link. This regulatory asymmetry—removing psychiatric warnings while maintaining zero ED action despite larger signal—is now documented with the first oral GLP-1 approval.

domains/health/glp1-pre-treatment-eating-disorder-screening-recommended-not-required.md

@@ -31,3 +31,10 @@ Review explicitly states 'no definitive evidence of the causal relationship betw
 **Source:** VigiBase 2.06M reports, aROR analysis
 
 VigiBase analysis quantifies eating disorder signal magnitude at aROR 4.17-6.80 (4-7x higher reporting odds), the highest psychiatric signal in the study. However, database lacked pre-existing psychiatric condition data, preventing distinction between medicine-induced reactions and indication bias—supporting screening recommendation but not mandate.
+
+
+## Supporting Evidence
+
+**Source:** FDA Wegovy oral label, January 2026
+
+FDA oral Wegovy prescribing information (January 2026) contains zero eating disorder screening requirements or contraindications for ED history. Label focuses on standard GLP-1 class warnings (thyroid tumors, pancreatitis, GI effects) with no behavioral health screening mandate, confirming the screening gap extends to oral formulations despite expanded access.

entities/health/wegovy-oral.md

@@ -0,0 +1,49 @@
+---
+type: entity
+entity_type: protocol
+name: Wegovy Oral (Oral Semaglutide)
+parent_company: Novo Nordisk
+status: FDA approved
+domain: health
+---
+
+# Wegovy Oral (Oral Semaglutide)
+
+**Type:** GLP-1 receptor agonist, oral formulation  
+**Manufacturer:** Novo Nordisk  
+**Status:** FDA approved January 2026  
+**Indication:** Weight management in adults with obesity or overweight + ≥1 comorbidity; cardiovascular risk reduction in adults with CVD + obesity/overweight
+
+## Overview
+
+First oral GLP-1 receptor agonist approved for weight management. Eliminates injection barrier that limited injectable semaglutide (Wegovy) adoption.
+
+## Clinical Evidence
+
+**OASIS 4 Trial (Phase III):**
+- Duration: 64 weeks
+- Population: n=307
+- Primary endpoint: Weight loss 16.6% (treatment) vs 2.7% (placebo) with reduced calorie diet + exercise
+- Safety: Serious adverse events 3.9% (treatment) vs 8.8% (placebo)
+- Common adverse reactions: nausea, vomiting, diarrhea (standard GLP-1 class profile)
+
+## Regulatory Status
+
+**FDA Label (January 2026):**
+- Boxed warning: Thyroid C-cell tumor risk (standard GLP-1 class warning)
+- NO eating disorder warning or screening requirement
+- Suicidal behavior/ideation warning REMOVED in 2026 review (no causal link found)
+- No contraindications for psychiatric comorbidity or eating disorder history
+
+## Market Significance
+
+Oral formulation expands addressable GLP-1 population by eliminating injection barrier. Accelerates trajectory toward mass-market adoption (1-in-8 Americans forecast).
+
+## Manufacturing
+
+Novo Nordisk North Carolina facilities.
+
+## Timeline
+
+- **2026-01-01** — FDA approval for weight management and cardiovascular risk reduction
+- **2026-01-01** — Launch with North Carolina manufacturing capacity

inbox/archive/health/2026-05-05-fda-oral-wegovy-approval-oasis4-jan2026.md

@@ -7,10 +7,13 @@ date: 2026-01-01
 domain: health
 secondary_domains: []
 format: article
-status: unprocessed
+status: processed
+processed_by: vida
+processed_date: 2026-05-05
 priority: medium
 tags: [glp-1, semaglutide, wegovy, oral-glp1, fda-approval, oasis4, access, eating-disorder-label]
 intake_tier: research-task
+extraction_model: "anthropic/claude-sonnet-4.5"
 ---
 
 ## Content