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Betamethasone's permission change is expected

By Lee, Hye-Kyung | translator Choi HeeYoung

22.04.25 06:00:26

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EMA's safety information review results

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As a result of reviewing safety information on drugs containing the skin disease treatment Betamethasone, precautions for use such as Pheochromocytoma are expected to be added.

The MFDS' Pharmaceutical Safety Evaluation Division prepared a change (draft) of permission based on the results of the European Medicines Agency's review of safety information on drugs containing "Betamethasone." This change includes both Betamethasone PO and Betamethasone Inj.

"Pheochromocytoma, which could be fatal, were reported after administration of systemic corticosteroids. Patients suspected or confirmed to have Pheochromocytoma should be administered only after evaluating the appropriate risk and benefit

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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