FDA re­quires boxed warn­ing for Sin­gu­lair and its gener­ics

The FDA on Wednes­day said it is re­quir­ing a boxed warn­ing and med­ica­tion guide for Mer­ck’s asth­ma and al­ler­gy drug Sin­gu­lair (mon­telukast) and its gener­ics to strength­en ex­ist­ing warn­ings about the risk of neu­ropsy­chi­atric events, in­clud­ing sui­cides, linked to the drug.

The agency al­so says that mon­telukast should not be used in pa­tients with mild symp­toms and should on­ly be used to treat al­ler­gic rhini­tis in pa­tients have not re­spond­ed to or who can­not take oth­er treat­ments.

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