2008 – Parents United for Pharmaceutical Safety and Accountability was formed by U.S. mothers who met after their children suffered horrendous side effects from the allergy/asthma drug Montelukast (Singulair).
2008 – Filed a Citizen’s Petition with the FDA requesting a boxed warning for neuropsychiatric side effects with Montelukast.
2010 – Testified at the NICHD’s Best Pharmaceuticals for Children Act Annual Meeting.
2011 – Conducted a legislative briefing for the Cody Miller Initiative for Safer Prescriptions, sponsored by NY Senator Kirsten Gillibrand.
2014 – Testified at FDA advisory committees:
At the May 2, 2014 Nonprescription Drugs Advisory Committee Meeting, we lobbied alongside Asthma & Allergy Network and Public Citizen against over the counter availability of montelukast. FDA Panel Rejects OTC Use of Montelukast (Singulair Allergy) “Among the witnesses at the public hearing portion of the hearing were 2 parents who described their children’s neuropsychiatric adverse reactions to montelukast.”
At the September 23, 2014 Pediatric Advisory Committee Meeting, we lobbied for greater awareness of Montelukast’s neuropsychiatric side effects, and submitted testimony with administrators of the Montelukast Side Effects Support and Discussion Group. The committee recommended FDA issue a reminder to healthcare professionals about neuropsychiatric side effects with Montelukast (distributed by FDA in March 2015). Montelukast’s Underrecognized Adverse Drug Events “During the open public hearing, a parent who represented numerous groups wanted to raise awareness of the potential for neuropsychiatric events with montelukast.”
2017 – With administrators of the Montelukast Side Effects Support and Discussion Group, we lobbied the FDA to reevaluate Montelukast’s safety profile, determine a mechanism for neuropsychiatric side effects, and acknowledge protracted side effects after stopping Montelukast and withdrawal.
2019 – FDA presented the results of their safety review to advisory committees on September 27th. Neuropsychiatric Events with Use of Montelukast in Pediatric Patients Alongside advocates from the Montelukast Side Effects Support and Discussion Group, Asthma & Allergy Network, Public Citizen, and other consumer advocacy groups, we called on the FDA to issue a boxed warning for mental health side effects with montelukast. Read our written statement.
FDA Panels Address Persistent Concerns About Montelukast Safety in Kids “The joint meeting of the FDA’s Pediatric Advisory Committee (PAC) and its Drug Safety and Risk Management Advisory Committee was held to address safety concerns voiced in a letter from Parents United for Pharmaceutical Safety and Accountability and Montelukast (Singulair) Side Effects Support and Discussion Group to the Office of Pediatric Therapeutics. In the letter, parents expressed concern about the connection between neuropsychiatric adverse events and montelukast.”
2020 – March 4, FDA Requires Boxed Warning for Mental Health Risks with Montelukast and acknowledges the possibility of protracted side effects and withdrawal symptoms.
We continue to work with other safety advocates to raise awareness of Montelukast’s neuropsychiatric side effects, and advocate for research.
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