New York AG calls for ‘more stringent’ Singulair safety warnings

New York At­tor­ney Gen­er­al Leti­tia James wants an “ur­gent” re­view of the safe­ty la­bel for a decades-old asth­ma and al­ler­gy med­ica­tion.

James last week raised con­cerns about neu­ropsy­chi­atric risks among mi­nors that were pre­scribed mon­telukast, bet­ter known as Sin­gu­lair. In 2020, the FDA added a black box warn­ing, its most se­ri­ous warn­ing, to mon­telukast’s la­bel af­ter re­ceiv­ing re­ports of “ag­i­ta­tion, de­pres­sion, sleep­ing prob­lems, and sui­ci­dal thoughts and ac­tions.” James’ of­fice called that warn­ing “in­suf­fi­cient” in a Feb. 21 let­ter to FDA Com­mis­sion­er Robert Califf.

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