MHRA Alert – Rybelsus (semaglutide) formulation transition and medication error risk

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.