Accord Healthcare Limited, UK has formally notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a critical defect related to its product documentation for Levetiracetam Accord 100mg/ml oral solution. Specifically, certain necessary safety information is absent in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC). This issue directly impacts regulatory compliance and patient safety communications. Clinical, quality, and regulatory teams are urged to review this announcement and respond appropriately.
What changed?
The issue arises from incomplete safety details within the product’s regulatory documentation. According to Accord Healthcare Limited, both the PIL and SPC of Levetiracetam Accord 100mg/ml oral solution fail to meet certain key safety requirements. Such omissions have the potential to leave healthcare professionals and patients without access to full guidance on the safe usage of the medication.
This notification was officially provided to the MHRA on September 30, 2025, highlighting the urgency for corrective action.
Who is affected?
Primary stakeholders include:
- Healthcare professionals utilizing Levetiracetam Accord 100mg/ml oral solution in treatment protocols.
- Patients prescribed this medication who rely on the PIL for accurate safety guidance.
- Regulatory teams tasked with ensuring compliance and addressing defects.
- Pharmacists and distributors managing inventory or patient queries.
The notification specifically encourages clinical, quality, and regulatory professionals to prioritize the review of documentation and implement measures to mitigate risks.
Regulatory findings and implications
What led to the defect?
The underpinning issue lies in omissions within the PIL and SPC provided alongside the Levetiracetam Accord 100mg/ml oral solution product. These documents are vital tools for patient and provider education and play a critical role in ensuring correct medication usage while preventing adverse effects.
Accord Healthcare Limited identified these lapses during routine checks. The company informed the MHRA of the oversight, emphasizing compliance risks while recognizing the regulatory and patient safety implications.
Potential impact
The absence of complete safety information may lead to incorrect administration or misunderstandings in usage. Additionally, regulatory authorities may review the matter further to ensure compliance with established guidelines.
For healthcare professionals prescribing Levetiracetam Accord, this notice serves as a warning to exercise caution and actively seek supplementary safety data.
Next steps for stakeholders
Accord Healthcare Limited is expected to issue revised versions of its PIL and SPC documents that address the identified omissions. Healthcare facilities administering this medication should update their records accordingly once new versions are released.
Professionals are advised to align their practices with MHRA directives and notify patients of potential risks stemming from incomplete information.
FAQ
- Q1: What is Levetiracetam used for?
A1: Levetiracetam is commonly prescribed to manage epilepsy by controlling seizures.
- Q2: Why is the PIL and SPC important?
A2: These documents provide essential safety, dosage, and adverse reaction information for medical professionals and patients.
- Q3: What actions should patients take now?
A3: Patients should consult their healthcare provider for detailed safety guidance until updated documents are provided.
Conclusion
This regulatory notification underscores the importance of rigorous checks in product documentation. Until Accord Healthcare Limited resolves the defect, healthcare providers should remain vigilant and ensure patients receive supplementary safety advice.
Clinical, quality, and regulatory teams should monitor for updates from both Accord Healthcare Limited and the MHRA, taking proactive steps to align practices with regulatory developments.
Disclaimer
This post is intended for healthcare professionals and regulatory teams. The information provided is not a substitute for legal or medical advice. Always consult official regulatory sources for definitive guidance.
Announcement link
For full information about the announcement, see the link below.
https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-levetiracetam-accord-100mg-slash-ml-oral-solution-accord-healthcare-limited-uk-el-25-a-slash-40