An early magazine advertisement for Merck’s breakthrough asthma and allergy medicine, Singulair, featured a happy child, hanging upside-down from a tree. Asthmatic kids could now breathe easier, the text assured, and side effects were “usually mild” and “similar to a sugar pill.”
When the drug launched in 1998, its label said the drug’s distribution in the brain was “minimal,” with no mention of psychiatric side effects.
The lawsuits cite the research of Julia Marschallinger, a cell biologist who has studied the drug along with colleagues at the Institute of Molecular Regenerative Medicine in Austria. That team found in 2015 that the drug’s distribution into the brain was more significant than its label described. The FDA cited Marschallinger’s work when it ordered Singlair’s black-box warning label.
Marschallinger and her colleagues in Austria came away with a different finding when they reviewed Merck’s original research and did some of their own. They started looking at Singulair as a potential dementia treatment in 2011. They became interested in that prospect in part because of the reports of psychiatric side effects, such as depression, agitation or hallucinations, from patients and medical providers. While troubling, the side effects showed the drug might affect the brain.
The FDA said Merck’s original animal studies were “quite limited and cannot provide any definitive information about the montelukast levels and activity in the brain.” The agency acknowledged that its reviewer’s description that drug levels declined over time in all tissues “did not fully reflect the data.”
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