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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