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Ronkonkoma family successful in lobbying FDA to include warning on asthma medication

The FDA announced this week it is putting a black box warning on the medication Montelukast -- the generic version of Singulair.

News 12 Staff

Mar 6, 2020, 8:53 PM

Updated 1,539 days ago

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The Food and Drug Administration is changing the way a popular asthma medication is labeled, netting a win for a Ronkonkoma family.
The FDA announced this week it is putting a black box warning on the medication Montelukast -- the generic version of Singulair.
The Ronkonkoma family has been fighting for the changes for two years after Nicholas had serious mental health side effects from taking the medication. Laura Marotta was emotional after learning about the victory for her 13-year-old son.
"The problem was, for 20 years Singulair has been prescribed to millions of asthma and allergy patients as medication that only acts on the airways," says Marotta. "But this new research, this new science showed it's actually working directly on the brain."
As News 12 has reported, Nicholas' life changed dramatically after taking Montelukast when he was 11. He started feeling sad, so he stopped taking the medication, but things only got worse -- bringing on depression, anxiety, hallucinations and insomnia.
"It was very scary because I didn't know what was going on, no one else did. I felt alone," says Nicholas Marotta.
At first doctors didn't make the connection, but Laura didn't give up and went online to learn more.
"We actually found out that this is quite common," says Laura Marotta. "Nicholas was not alone."
Five months ago, the mother and son joined other parents and advocacy groups in Washington, D.C. to testify in front of the FDA.
Because of their fighting, the FDA will require the boxed warning about the serious mental health side effects of Montelukast.
"I feel like it's really important for everyone to remember you need to ask questions, and you need to research everything that you put into your body," says Laura Marotta.
The FDA also acknowledged that side effects may develop or continue after the medication is stopped. It's recommending doctors avoid prescribing the drug for mild symptoms like allergies.
 


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