Swissmedic has issued a health professional communication regarding a change in the shelf life of Lecigon, a medication containing carbidopa, entacapone, and levodopa. The update applies to clinical, quality, and regulatory teams involved in its use, storage, and distribution.
Effective October 24, 2025, Lecigon users and stakeholders should be aware of regulatory modifications addressing reduced stability and storage considerations for the product.
What changed?
Swissmedic announced a reduction in the shelf life of Lecigon, citing updated stability data provided by the manufacturer. This adjustment reflects the need for tighter controls to ensure product efficacy and patient safety over time.
Lecigon is widely used for the treatment of Parkinson’s disease, leveraging its combination of active ingredients to manage symptoms effectively. However, new evidence has revealed limitations in the compound’s long-term durability under specific storage conditions.
Who is affected?
This update impacts clinical, quality assurance, and regulatory teams handling Lecigon. Healthcare professionals prescribing or administrating Lecigon should prioritize checking updated expiration dates. Additionally, pharmacists and storage teams must adjust inventory management practices to align with the revised shelf-life guidelines.
Patients and caregivers may also be indirectly concerned as prescriptions involving Lecigon could necessitate changes or additional advisories from medical teams.
Actions required
Swissmedic strongly urges stakeholders to implement the following measures:
- Review and confirm changes to Lecigon’s shelf life using Swissmedic’s official communication.
- Update clinical protocols and workflows accordingly to ensure compliance.
- Train relevant staff about implications of the new storage data.
- Communicate adjustments to patients relying on Lecigon and ensure proper instructions for dosage and product handling.
Adhering to these recommendations minimizes risks related to suboptimal efficacy or regulatory non-compliance.
FAQs
Q1: Why was the shelf life reduced?
Recent stability data indicated a need for stricter storage parameters for Lecigon, leading to a reduction in its previously stated shelf life by Swissmedic.
Q2: How should pharmacies handle existing stock?
Pharmacies should verify the expiration dates of every unit currently in inventory and dispose of products that no longer comply with the updated guidelines.
Q3: Will this impact patient treatment plans?
In certain cases, adjusted shelf life could necessitate proactive communication with patients to address prescription timelines and safety concerns.
Recap
Swissmedic’s update on Lecigon shelf life is a precautionary regulatory action based on stability findings. Healthcare and regulatory professionals must ensure proper implementation of changes to safeguard therapeutic efficacy and compliance.
Disclaimer
This post is intended for informational purposes only and should not be considered legal or medical advice. Stakeholders must refer to official Swissmedic communications for comprehensive guidance.
Swissmedic Reference
For full information about the Swissmedic announcement, see the link below.