PV Bulletin

Choline Salicylate PSUSA/00000732/202512 - Safety Update Assessment

New regulatory outcomes for choline salicylate established warnings regarding pregnancy and peptic ulcer history.

Primary source: View

PV Impact Brief

Urgency: HighConfidence: high

What changed

Choline salicylate products must now include warnings about not using them during the last trimester of pregnancy and advise caution during the first six months unless absolutely necessary. Additionally, warnings must be included for patients with a history of or current peptic ulcers.

Why it matters

These regulatory updates are crucial for compliance in pharmacovigilance and ensure that healthcare providers are aware of potential risks associated with choline salicylate, thereby protecting patients.

Action needed

Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 28, 2026

Full briefing

Practical implication

Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.

The EMA has issued a variation for choline salicylate's marketing authorization, including updated safety warnings. These changes are based on a periodic safety update assessment (PSUSA) and affect labeling requirements.

What changed: Choline salicylate products must now include warnings about not using them during the last trimester of pregnancy and advise caution during the first six months unless absolutely necessary. Additionally, warnings must be included for patients with a history of or current peptic ulcers.

Why it matters: These regulatory updates are crucial for compliance in pharmacovigilance and ensure that healthcare providers are aware of potential risks associated with choline salicylate, thereby protecting patients.

Practical implication: Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.

View original source

  • Source: EMA - What's new
  • Published at source: 2026-08-28T12:38:47.000Z
  • Discovered by monitor: 2026-08-29T05:25:08.258Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Reporting Requirement#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu

Related updates for your role

publicEuropean Medicines Agency (EMA) · European Union · Updated Aug 28, 2026

PSUSA/00011041/202510 - Periodic Safety Update Report Single Assessment

Urgency: High

The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 28, 2026

FDA Approves Stelara for Pediatric Ulcerative Colitis

Urgency: High

Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.

LabelingSignal ManagementQPPV
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: QPPV, Labeling Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 28, 2026

FDA Approves First-in-Class Drug Mimrylo for Polycythemia Vera

Urgency: High

Labeling and risk management updates are required to reflect the new drug approval, including the incorporation of safety and efficacy data from the VERIFY trial.

LabelingSignal ManagementQPPV
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: QPPV, Labeling Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 28, 2026

Early Alert: IV Start Kit Issue from Avid Medical

Urgency: High

Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward