MHRA: Levetiracetam Neuraxpharm PIL Discrepancy Stock to Remain

• Neuraxpharm UK Limited reported discrepancies in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for its Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet.
• All current stock is affected, but the product is deemed critical for patients unable to take tablet forms, so supply will continue without recall.
• The MHRA issued a Class 4 Medicines Defect Notification, EL(26)A/40, regarding this issue.
• Healthcare professionals are advised to provide patients with a supplementary letter detailing the missing PIL information during dispensing.
• Corrected PILs are expected in packs distributed from June 2027, with interim measures in place until then.

Crucially, where feasible, patients should be provided with a supplementary letter detailing the missing information from the PIL at each subsequent dispensing.

Neuraxpharm UK Limited has identified significant discrepancies within the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for its Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet product. This issue, which affects all currently available stock, involves a divergence between the company's existing product safety information and the established reference product data. The active ingredient in question is levetiracetam, a medication crucial for many patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) was informed of this issue, leading to the issuance of a Class 4 Medicines Defect Notification, identified as EL(26)A/40. This notification highlights that the current PIL for the oral solution granules does not fully align with the comprehensive information found in the corresponding reference product documentation. This situation presents a challenge for both pharmaceutical companies and healthcare providers in ensuring patients receive complete and accurate drug information.

Despite the identified information gap, a decision has been made to continue the supply of the affected batches without repackaging. This unusual step was taken following collaborative discussions between the MHRA and the Department of Health and Social Care. The rationale behind this decision stems from the product's critical nature for a specific patient population: those who cannot use tablet formulations and depend entirely on this granular oral solution. A full recall or halt in supply would pose a significant risk to these vulnerable patients.

The regulatory bodies have prioritized uninterrupted access to this essential medicine over an immediate, comprehensive correction of the PIL. Consequently, the current stock, despite its documented information discrepancies, will remain in circulation. It is important to note that a fully corrected version of the Patient Information Leaflet, incorporating all necessary details, is not yet accessible on the MHRA Products website, indicating an ongoing process to rectify the documentation.

Healthcare professionals, including general practitioners, independent prescribers, and specialist prescribers, are instructed to continue prescribing and dispensing Levetiracetam Neuraxpharm in accordance with the existing approved product information. Patient management should proceed based on individual clinical circumstances, ensuring continuity of care. This directive underscores the importance of clinical judgment in light of the known documentation issue.

For those involved in dispensing the affected product, such as pharmacy teams, the MHRA advises a careful review of the information contained within the defect notification. Crucially, where feasible, patients should be provided with a supplementary letter detailing the missing information from the PIL at each subsequent dispensing. This letter, also accessible via a QR code, aims to bridge the information gap. Neuraxpharm Limited has committed to supplying these supplementary letters with all future deliveries to facilitate direct provision to patients. Healthcare providers can request hard copies of this supplementary information by contacting Medinfo-uk@neuraxpharm.com or calling +44 (0) 330 128 0919.

The guidance explicitly states that there is no expectation for healthcare providers to retrospectively contact patients who have already received the product. However, if patients present with specific symptoms or concerns, they should be promptly referred to the appropriate healthcare professional for evaluation and guidance. This approach balances patient safety with the practicalities of managing a critical medicine with a known documentation defect.

Neuraxpharm Limited has provided a timeline for the complete resolution of the PIL discrepancy. The company has confirmed that all packs of Levetiracetam Neuraxpharm Granules for Oral Solution in Sachet distributed from June 2027 onwards will contain an updated and fully correct Patient Information Leaflet. This future date indicates the complexity and lead time required for pharmaceutical companies to implement such changes across their supply chains and regulatory approvals. Until then, the interim measures, particularly the provision of supplementary information, remain vital for ensuring patient understanding and safety regarding their medication.

Compliance officers and legal counsel for pharmaceutical companies and healthcare providers must be aware of the MHRA's guidance on dispensing critical medicines with known Patient Information Leaflet (PIL) discrepancies. This case highlights the need to implement procedures for providing supplementary information to patients (e.g., via a supplementary letter) to mitigate risks associated with incomplete product information, even when a full recall is not feasible due to patient criticality.

Source: Original reporting via MHRA Class 4 Medicines Defect Notification