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Caution required for use of ADHD drug methylphenidate

By Lee, Hye-Kyung | translator Kim, Jung-Ju

24.01.15 12:05:01

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MFDS prepares labeling changes to 14 items including ¡®Concerta OROS ER Tab¡¯



The warnings and precaution section of the attention deficit hyperactivity disorder (ADHD) treatment ¡®methylphenidate¡¯ is expected to add warnings for increased intraocular pressure and glaucoma.

The Ministry of Food and Drug Safety (MFDS) prepared a change to the label of drugs that contain methylphenidate based on a review of the safety information on methylphenidate products by the U.S. Food and Drug Administration (FDA) and is conducting an opinion inquiry until the 26th.

14 methylphenidate products are currently approved in Korea, including Janssen Korea¡¯s ¡®Concerta OROS Er Tab,¡¯ Whan In Pharm¡¯s ¡®Penid Tab,¡¯ and Myung-In Pharm¡¯s ¡®Perospin Tab.¡¯

The labeling

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