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Safety Communications: US FDA Panel Offers Menu Of Options For Singulair's Risks

Executive Summary

A common theme among the public speakers at the advisory committee was that their children's prescribers never informed them of the existing warning and precaution in the label. With that in mind, the US FDA now heads to the drawing board after a joint panel offers a series of options to more effectively communicate the potential neuropsychiatric risks associated with Singulair.

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