Key Summary
- The MHRA issued a class 4 medicines defect notification for apixaban.
- The patient information leaflets did not contain up‑to‑date information in some batches.
- The drug manufacturer, Sandoz, informed MHRA about the issue.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 medicines defect notification for several batches of apixaban, used to treat blood clots in children, as the patient information leaflets (PILs) did not contain up‑to‑date information.
The drug manufacturer, Sandoz, informed the MHRA that the PIL in the affected batches of apixaban 2.5mg and 5mg tablets lacked information relating to:
- The newly authorised paediatric indication (children aged 28 days to <18 years).
- Updated guidance regarding use following spinal/epidural catheter removal.
- The dose depends on the body weight, and will be calculated by the doctor.
Sandoz has clarified that the quality of the tablets is not impacted by the missing information.
After discussion with the Department of Health and Social Care, the MHRA has decided that these batches will not be repackaged and will continue to be distributed.
The updated PIL wording that follows will be included in all future manufactured batches.
The MHRA states that healthcare professionals should also inform patients and carers of the approved dosing advice for children or patients with a catheter fitted.
Upon request, Sandoz will provide hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock can be supplemented with the correct PIL information.
