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In early 2020, the Food and Drug Administration responded to decades of escalating concerns about a commonly prescribed drug for asthma and allergies by deploying one of its most potent tools: a stark warning on the drug’s label that it could cause aggression, agitation and even suicidal thoughts.
The agency’s label, which was primarily aimed at doctors, was supposed to sound an alert about the 25-year-old medication, Singulair, also known by its generic name, montelukast. But it barely dented use: The drug was still prescribed to 12 million people in the United States in 2022.
Children face the greatest risks of the drug’s ill effects, and while usage by minors did decline, it was still taken by 1.6 million of them — including Nicole Sims’s son. Ms. Sims had no idea why, at 6, her son started having nightmares and hallucinations of a woman in the window. When he told her that he wanted to die, Ms. Sims went online, desperate for answers.
Only then did she learn about the F.D.A. warning. She also found a Facebook support group with 20,000 members for people who had experienced side effects of the drug. Members of the group recounted a haunting toll that they linked to the drug with the help of peers, not their doctors.
Singulair’s Boxed Warning
The Food and Drug Administration added a boxed warning to Singulair in 2020.
Singulair Prescriptions
More than 12 million people in the United States fill at least one prescription for Singulair or montelukast each year.
15
million people
ALL AGES
10
5
Ages 12
and under
2018
2020
2022
15
million people
ALL AGES
10
5
Ages 12
and under
2018
2019
2020
2021
2022
Singulair Anecdotes
Excerpts from testimonials submitted to the F.D.A. in 2022 before a meeting of experts studying how montelukast impacts the brain.
“In April the voices started. I thought I was going insane. I would look around the room, knowing I heard a voice even when there was no one there. It began to tell me to close the windows. Or just single words calling me names (b*tch, asshole, loser). At that point I became even more withdrawn not knowing what to do. I would sleep for days at a time, just to avoid the voice. … The day it told me to hurt myself with a knife I went off the Singulair. … Within a week I noticed the voice was gone.”
“Worried about our son, I was Googling psychosis in toddlers. As I tried to figure things out, he began to lose hope at home after big explosive episodes. If he wasn’t in complete denial of an outburst (he literally didn’t recall anything about them), he was so distraught he said he was so scared and didn’t want to live. He would bang his head against the wall and I found kitchen knives under his pillow — thankfully only the butter knives he could access. All at only three years old.”
“And then came the words. He would say ‘I’m not worth anything.’ ‘I’m so stupid.’ ‘Everything would be better if I wasn’t here.’ He became consumed with death. Always asking me questions about dying. Telling me he didn’t think he should be alive. At age 7 he actually attempted to take his life. I had to tackle my 7 year old child as we fought over the knife he grabbed in the kitchen. I had to hold him while he screamed uncontrollably that he didn’t want to be alive anymore. AT AGE 7.”
“In April the voices started. I thought I was going insane. I would look around the room, knowing I heard a voice even when there was no one there. It began to tell me to close the windows. Or just single words calling me names (b*tch, asshole, loser). At that point I became even more withdrawn not knowing what to do. I would sleep for days at a time, just to avoid the voice. … The day it told me to hurt myself with a knife I went off the Singulair. … Within a week I noticed the voice was gone.”
“Worried about our son, I was Googling psychosis in toddlers. As I tried to figure things out, he began to lose hope at home after big explosive episodes. If he wasn’t in complete denial of an outburst (he literally didn’t recall anything about them), he was so distraught he said he was so scared and didn’t want to live. He would bang his head against the wall and I found kitchen knives under his pillow — thankfully only the butter knives he could access. All at only three years old.”
“And then came the words. He would say ‘I’m not worth anything.’ ‘I’m so stupid.’ ‘Everything would be better if I wasn’t here.’ He became consumed with death. Always asking me questions about dying. Telling me he didn’t think he should be alive. At age 7 he actually attempted to take his life. I had to tackle my 7 year old child as we fought over the knife he grabbed in the kitchen. I had to hold him while he screamed uncontrollably that he didn’t want to be alive anymore. AT AGE 7.”
Singulair’s Side Effects
People taking the drug have 30 times the odds of reporting abnormal behavior or aggression compared to those taking other drugs.
Same reporting rate
as other drugs
10
times
20
times
30 times
more likely
Abnormal behavior
Aggression
Anger
Suicidal thoughts
Crying
Suicide attempt
Irritability
Depression
Anxiety
Drowsiness
Same rate as
other drugs
10
times
20
times
30 times
more likely
Abnormal
behavior
Aggression
Anger
Suicidal
thoughts
Crying
Suicide
attempt
Irritability
Depression
Anxiety
Drowsiness