Safety alert over diabetes medication formulation change

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety warning regarding the transition to a new formulation of Rybelsus (semaglutide) tablets, due to the risk of medication error during the changeover period.

Both the original and new formulations of Rybelsus, used to treat adults with type 2 diabetes, will temporarily be available on the market until approximately 31 January 2026, although original formulation stock may remain in the supply chain beyond this date.

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The MHRA is warning that prescribing errors could result in overdoses if healthcare professionals mistakenly prescribe more than one tablet per day of the new formulation to match the milligram strength of the original version.

The new formulation has increased bioavailability, meaning lower-strength tablets provide the same clinical effect as the higher-strength tablets in the original formulation.

Specifically, the original 3mg starting dose is replaced by a 1.5mg tablet, the 7mg maintenance dose by a 4mg tablet, and the 14mg maintenance dose by a 9mg tablet.

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Healthcare professionals are advised to:

• Prescribe the new formulation for all new patients starting Rybelsus once it becomes available in prescribing systems;
• Systematically switch existing patients to the new formulation and ensure this change is documented and communicated across care settings;
• Clearly inform patients that they should continue to take only one tablet per day and that the lower-strength tablets in the new formulation are bioequivalent to the higher-strength tablets in the previous version;
• Ensure all relevant staff are aware of the revised dosing and formulation changes; and
• Refer to the Direct Healthcare Professional Communication for full details of the new formulation.

The MHRA has stressed the importance of consistent communication with patients to avoid confusion, reinforce correct usage, and maintain disease control.

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Patients should be directed to the transition guide if they have questions, and any medication errors or adverse events should be reported via local risk management systems and the Yellow Card scheme.

This article was first published by our sister title The Pharmacist