2008 - Parents United for Pharmaceutical Safety and Accountability was formed by U.S. mothers Kate Miller, Jenna Markle, Lynne Faraone, and Jan Gilpin, who met after their children suffered horrendous side effects from the allergy/asthma drug montelukast.


2008 - PUPSA filed a Citizen's Petition with the FDA requesting a boxed warning for neuropsychiatric side effects with montelukast.

2009 - PUPSA Advocates joined the Montelukast Side Effects Support and Discussion Group, founded in 2008 by a Canadian mom.


2010 - PUPSA representatives spoke at the NICHD's Best Pharmaceuticals for Children Act Annual Meeting.  


2011 – PUPSA conducted a legislative briefing for the Cody Miller Initiative for Safer Prescriptions, sponsored by NY Senator Kirsten Gillibrand.


2014 - PUPSA representatives testified before two 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)

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 these side effects (distributed by FDA in March 2015).

Montelukast's Underrecognized Adverse Drug Events


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 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 other 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 PUPSA's written statement and the hundreds of testimonials submitted by consumers. 

FDA Panels Address Persistent Concerns About Montelukast Safety in Kids
 

2020 - March 4, FDA Requires Boxed Warning for Mental Health Risks with Montelukast and acknowledges the possibility of protracted side effects and withdrawal symptoms.

PUPSA continues to work with other safety advocates to raise awareness of the nature and mechanism of montelukast's neuropsychiatric side effects, and advocate for research into withdrawal and protracted side effects with montelukast.

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Queensbury Mom Pushes for Better Drug Warnings After Son's Suicide

Mentor mom Lynne Faraone helped sound the alarm over side effects from popular Singulair

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