A “black box” warning connecting a popular asthma medication and psychological episodes as extreme as suicidal thoughts is starting to come back out of the shadows.
Questions about the medication – Montelukast (aka Singulair) – first arose four years agp during the COVID-19 pandemic but didn’t make much of a dent in the news cycle. Because of that limited coverage, it left many healthcare professionals and patients completely unaware of the risks.
Originally, the FDA issued the warning after reviewing evidence of mental health side effects of the drug. In addition to suicidal thoughts, those side effects included behavior changes, agitation/aggression and depression, not to mention sleeping disorders, particularly in seniors.
A key element in the FDA’s warning was that while these issues may go away once someone stops taking Montelukast/Singulair, they may linger.
But now, the UK’s version of the FDA, the Medicines and Healthcare products Regulatory Agency, is raising the issue again and flying the caution flag even higher. MHRA 2023 Yellow Card data counts 143 reports of psychiatric disorders associated with the drug, the highest-ever number.
As part of the drug safety update, the MHRA advised prescribers to carefully assess both the benefits and the risks of continuing treatment if neuropsychiatric reactions occur.
The FDA needs to get back on this
Now a third entity – New York Attorney General Letitia James – has called on the FDA to take another look at the situation. In her letter to the agency, James was irate that it has been nearly four years since the FDA seemed serious about the issue. She said it’s putting too many children at risk.
“Since that decision in March 2020, the prevalence of tragic adverse mental health events, including aggression, depression and suicide, continue to be widely reported, and disproportionately so for pediatric patients,” James wrote.
“Of the estimated 12 million people prescribed the medication, an estimated 1.6 million are children. … Parents and guardians have the right to be fully informed of a medication’s potential side effects when making choices about their children’s health. The risks associated with taking Singulair are far too dire to come without a very clear warning.”
Do you take Singulair/Montelukast?
If you take this medication, you now have a good reason to ask some serious questions. Not only about any associated side effects that you may have felt, but possibly finding an alternative medication.
According to Drugwatch.com, for anyone concerned about the risks of Singulair or who have experienced its related side effects, the other medications available for treating asthma and allergies include:
- Advair (asthma)
- Allegra (allergies)
- Claritin (allergies)
- Flonase (allergies)
- Loratadine (allergies)
- Prednisone (asthma and allergies)
- Promethazine (allergies)
- Symbicort (asthma)
- Xolair (asthma)
- Zyrtec (allergies)
“Speak with your healthcare provider to explore your treatment options. To ensure safe and effective management of your symptoms, always consult your doctor before discontinuing Singulair or starting a new medication,” Drugwatch recommends.
But if you experience side effects, you should speak with your doctor immediately or if there’s someone experiencing suicidal thoughts, contact the National Suicide Prevention Lifeline at 1-800-273-TALK (1-800-273-8255).
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