March 4, 2020 / 7:33 PM / a month ago

BRIEF-FDA Says Requires Boxed Warning About Serious Mental Health Side Effects For Montelukast

March 4 (Reuters) - FDA-

* FDA- REQUIRES BOXED WARNING ABOUT SERIOUS MENTAL HEALTH SIDE EFFECTS FOR ASTHMA AND ALLERGY DRUG MONTELUKAST

* FDA- ADVISES RESTRICTING USE OF MONTELUKAST FOR ALLERGIC RHINITIS

* FDA- FOR RHINITIS, DETERMINED MONTELUKAST SHOULD BE RESERVED FOR THOSE WHO ARE NOT TREATED EFFECTIVELY WITH/ CANNOT TOLERATE OTHER ALLERGY MEDICINES

* FDA- FOR ASTHMA PATIENTS , RECOMMEND HEALTH CARE PROFESSIONALS CONSIDER BENEFITS & RISKS OF MENTAL HEALTH SIDE EFFECTS BEFORE PRESCRIBING MONTELUKAST

* FDA- MONTELUKAST PRESCRIBING INFORMATION ALREADY INCLUDES WARNINGS ABOUT MENTAL HEALTH SIDE EFFECTS, BUT MANY PROFESSIONALS, PATIENTS ARE NOT AWARE

* FDA- CONTINUE TO RECEIVE REPORTS OF MENTAL HEALTH SIDE EFFECTS REPORTED WITH MONTELUKAST USE Source text: (bit.ly/2VMl5mi)

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