US FDA Orders Singulair Boxed Warning On Neuropsychiatric Events Despite ‘Limited’ Evidence
Therapeutic alternatives and lack of prescriber and parent knowledge about existing warnings drove agency’s decision, despite internal concerns about the adequacy of the evidence to support the safety action.
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How should FDA make sure new safety information gets widely disseminated – especially against a history of many communications that have not shown the sustained ability to reach the most active prescribers? The agency got an earful of suggestions from the most recent safety review of the asthma/allergy drug montelukast.
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.
Joint panel of the Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee was split on whether the US FDA should add a black box warning to the label of Merck's now generic Singulair, which is currently labeled with a warning and precaution about a risk of psychiatric events.