The asthma and allergy medicine montelukast, brand name Singulair, will now come with a Boxed Warning or “Black Box Warning,” the most prominent and serious of FDA warnings about prescription drugs.

According to a news report, "Montelukast prevents asthma attacks and asthma ignited by exercise in people above the age of 6. Doctors can also prescribe it for long-term asthma treatment in adults and children more than 1 year old. Allergy prevention also makes the drug’s can-do list."

The FDA is taking additional steps and labeling the drug for its "serious mental health side effects", including agitation, depression, sleeping problems, and suicidal thoughts and actions. The FDA will also recommend that montelukast (Singulair) be prescribed for hay fever sufferers only when there’s no other medical option.

The idea that Singulair causes serious mental health side effects has been studied for years. In 2017, a study linked the drug to depression and nightmares in children. In 2018, another report found “167 reports of psychiatric events in children and adolescents” from 2000 to 2017.

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