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Antiepileptic perampanel¡¯s adverse event rate at 32%

By Lee, Hye-Kyung | translator Alice Kang

22.07.05 06:18:00

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16 items from 3 companies marketed in Korea¡¦ MFDS conducts opinion inquiries until the 14th for indication change



Results of the 6-year post-marketing surveillance (PMS) on the antiepileptic ingredient perampanel showed that 17 cases of serious adverse reactions whose causal relationship cannot be ruled out were reported.

As 287 cases of unexpected adverse reactions whose causal relationship cannot be ruled out were also reported, the indication for perampanel is set to be updated to account for these changes.

The Ministry of Food and Drug Safety had announced that it had recently released an order (draft) to change the indication for 16 perampanel items owned by Eisai Korea, Whanin Pharmaceutical, and Myung In Pharm according to the reassessment results, and will be conducting an opinion inquiry o

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