FDA Safety Labeling Update — BRIVIACT (brivaracetam)

Source: FDA Drug Safety-related Labeling Changes database (BRIVIACT entry). FDA Access Data

Last update

• Date: August 28, 2025 (SUPPL-17). FDA Access Data

What changed (high-level)

The August 28, 2025 supplement adds a new safety subsection describing Serious Dermatologic Reactions (including Stevens–Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]) and updates related adverse reaction and patient counseling sections to reflect these postmarketing reports. FDA Access Data

Which label sections were updated

1. Section 5 — Warnings and Precautions
   • New subsection 5.5: Serious Dermatologic Reactions. Describes SJS/TEN reported with BRIVIACT, time to onset (3–45 days), recommendation to discontinue at first sign of a rash unless clearly not drug related, and not to resume BRIVIACT if a serious dermatologic reaction is suspected. FDA Access Data
2. Section 6 — Adverse Reactions
   • 6.2 Postmarketing Experience: Adds “Skin and Subcutaneous Tissue Disorders: Serious dermatologic reactions (e.g., SJS and TEN)” and notes that these events are identified during post-approval use and frequency is uncertain due to voluntary reporting. Also links to Warnings & Precautions (5.5). FDA Access Data
3. Section 17 / PCI / Patient Information / Medication Guide
   • Medication Guide / Patient Counseling Information updated to include language warning patients about serious skin reactions, what signs to watch for (rashes, blisters, peeling skin, sores in mouth, hives), and instructions to seek immediate medical care and not stop therapy without consulting a provider. Counseling guidance for clinicians to advise patients on early signs is also added. FDA Access Data

Why the update was made

• Postmarketing reports of severe dermatologic reactions (SJS/TEN) in patients receiving BRIVIACT prompted FDA to require labeling changes so prescribers and patients are informed of this potentially life-threatening risk. The time window reported (3–45 days after initiation) supports adding early vigilance language. Because these adverse events were identified after approval through voluntary reports, the label clarifies that frequency cannot be reliably estimated from those data. FDA Access Data

Clinical implications / recommended actions

• Prescribers:
  • Counsel patients about early signs of serious skin reactions before initiating BRIVIACT.
  • Discontinue BRIVIACT immediately at the first sign of a rash unless an alternative non-drug cause is clear. Do not resume BRIVIACT if a serious dermatologic reaction is suspected.
  • Report suspected serious skin reactions to pharmacovigilance contacts and regulatory reporting systems (e.g., FDA MedWatch). FDA Access Data
• Pharmacists:
  • Reinforce counseling points at dispensing: warning signs, urgency of seeking care, and not stopping treatment without medical advice (except in emergency situations when immediate evaluation is needed). FDA Access Data
• Patients / Caregivers:
  • Watch for early symptoms: rash, blisters, peeling skin (including around mouth/nose/eyes/genitals), mouth sores, hives, or signs of allergic reaction (swelling, breathing difficulty). Seek immediate medical attention and contact your prescriber. FDA Access Data

Bottom line

The August 28, 2025 labeling change for BRIVIACT adds explicit warnings about rare but serious dermatologic reactions (SJS/TEN) observed postmarketing, updates the adverse reactions and patient counseling sections accordingly, and emphasizes early discontinuation and patient education to reduce risk of severe harm. Clinicians should integrate the new language into pre-treatment counseling and monitoring workflows. FDA Access Data