Medication Safety Alert: Rybelsus® Formulation Change
The MHRA has issued a safety alert regarding a planned transition to a new formulation of Rybelsus® (semaglutide tablets). During this transition period, both the original and new formulations will be in circulation. Although bioequivalent, they carry different stated mg doses, creating a significant risk of medication error.
Key Points
- Two formulations of Rybelsus® will coexist during the transition period
- Different stated doses despite bioequivalence increases confusion risk
- Medication errors could result in patient harm
- All clinical and pharmacy staff involved in dispensing, administration, and patient counselling should be aware of this change
Affected Medication
- Rybelsus® (semaglutide tablets) – all strengths
Recommended Actions
- Review your local prescribing and dispensing protocols for semaglutide tablets
- Ensure all staff are briefed on the formulation transition and the risk of confusion
- Double-check prescriptions and dispensing records, particularly during the transition period
- Reinforce patient counselling to confirm the correct formulation and dose
- Report any suspected medication errors or near-misses to your local reporting system and the MHRA Yellow Card scheme
Further Information
For full details of this alert, visit the MHRA Drug Safety Update page.