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Report of severe skin SE such as rash of Phenytoin

By Lee, Hye-Kyung | translator Choi HeeYoung

22.06.21 06:18:05

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The MFDS conducts an opinion inquiry based on EMA safety information review results



Precautions for severe skin abnormalities will be newly established in the anticonvulsant Phenytoin.

The Drug Safety Evaluation Division of the MFDS has prepared a change (proposal) in domestic drug permits based on the results of the EMA's review of drug safety information.

The changes will be checked by the pharmaceutical industry and others until the 29th under the terms of "careful administration", "general caution", "Adverse reaction" and "interaction" of the precautions for use.

As a result of the EMA safety information review, severe skin adverse reactions such as deprivation dermatitis, dermal mucosal eye syndrome (Stephens-Johnson syndrome), and toxic epidermal nec

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