On September 30, 2025, Hikma Farmacêutica (Portugal) S.A issued a notification to the Medicines and Healthcare products Regulatory Agency (MHRA) regarding an oversight in the Patient Information Leaflet (PIL) for Gemcitabine 2g/52.6ml concentrate for solution for infusion, batch number CB0033. Clinical, quality, and regulatory teams are advised to review this defect promptly as the omission could impact patient safety information.
What changed?
The manufacturer, Hikma Farmacêutica, reported a critical defect in the Patient Information Leaflet included with batch CB0033 of Gemcitabine 2g/52.6ml concentrate for infusion. The leaflet failed to provide essential details regarding possible side effects associated with the medication. While the defect does not involve the drug’s formulation, it does compromise the communication of safety information, which is crucial for informed patient use.
Who is affected?
This issue primarily affects individuals responsible for prescribing or administering Gemcitabine medication from batch CB0033, including clinicians, pharmacists, and healthcare professionals. Patients receiving treatment from this batch may lack access to comprehensive safety information in their PIL, necessitating additional vigilance from their healthcare providers to ensure informed use of the medication.
Healthcare practitioners
Medical professionals must be aware of the defect to provide patients with supplementary safety details that are missing from the leaflet. This includes explaining potential side effects and monitoring adverse reactions.
Patients
Patients are indirectly affected by this oversight as it may prevent them from fully understanding the risks of the medication. It is crucial for healthcare providers to bridge the gap in safety communication.
Implications and actions
The omission in the Patient Information Leaflet constitutes a Class 4 medicines defect. While this classification signifies a low risk to public health, it remains a regulatory and professional concern for ensuring patient education and compliance. Here are key actions recommended:
- Healthcare providers: Inform patients about potential side effects as prescribed by regulatory guidelines and local medical protocols.
- Pharmacists: Verify batch numbers and advise prescribers to discuss safety concerns with patients directly.
- Regulatory teams: Monitor the recall status or further MHRA communications regarding corrective measures.
Frequently Asked Questions
1. What specific side effects are missing from the leaflet?
The manufacturer has not disclosed precisely which side effects were omitted, but clinical teams should provide a comprehensive overview based on established Gemcitabine safety information.
2. Is this only relevant to batch CB0033?
Yes, the defect is currently limited to batch CB0033 of Gemcitabine 2g/52.6ml concentrate for infusion.
3. Should the medication still be administered?
Administration is not contraindicated; however, healthcare providers must ensure patients are informed about potential risks.
Conclusion
This notification underscores the importance of accurate and complete patient safety documentation. Clinical and regulatory teams should collaborate to mitigate the potential risks posed by this defect and ensure patients remain fully informed. For batch CB0033, corrective communication is essential to uphold compliance and safeguard patient care.
Disclaimer
This article is intended for clinical and regulatory professionals. It is not legal or medical advice and should not replace specific guidance issued by the MHRA or healthcare authorities.
Official announcement
For full information about the announcement, see the link below.