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By Gary Fitzgerald

Allergy & Asthma Network’s voices were heard – the U.S. Food and Drug Administration (FDA) announced it is requiring a boxed warning for montelukast due to mental health, behavior and mood-related changes associated with the medication.

“Allergy & Asthma Network was the only national patient organization to advocate for the black box warning,” Tonya Winders, President and CEO of the Network, told “We have many reports of families impacted by the neuropsychiatric side effects of montelukast.”

Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts and actions, however many healthcare professionals, patients and families are not aware of the risk.

The boxed warning is FDA’s most prominent warning, added to the prescribing information for montelukast to describe these serious mental health side effects.

One family impacted by montelukast mental health side effects was the Teehee family of Tahlequah, Oklahoma.

“It is important to recognize the warning signs and talk with your doctor about alternative treatments,” Winders says.

If you or your child experiences mental health, behavior or mood-related changes while taking montelukast, FDA advises stopping the treatment and discussing the side effects with a doctor. These changes may include:

  • Agitation or hostility
  • Depression
  • Suicidal thoughts and actions
  • Bad or vivid dreams
  • Disorientation or confusion
  • Anxiety
  • Hallucinations
  • Obsessive-compulsive symptoms
  • Difficulty sleeping
  • Memory problems

Montelukast (brand name Singulair®) is prescribed for asthma and allergic rhinitis treatment in adults and children. It was first approved by FDA in 1998.

Alternative treatments may include allergen immunotherapy and avoidance measures; for allergic rhinitis patients, certain over-the-counter medications may also help, including antihistamines and corticosteroid nasal sprays.