Singulair, now a generic, is still used by millions of people in the United States even after thousands of patients and dozens of studies have described harm.
The F.D.A.’s handling of Singulair illustrates systemic gaps in the agency’s approach to addressing troubling side effects from medicines approved long ago — and to warning the public and doctors when serious issues arise.
With concerns lingering, researchers, including some at the F.D.A., have returned to basic animal studies to examine possible effects of montelukast in the brain, a quest that could take a decade to complete.
Settling the question of how common the problems are remains unlikely, said Dr. Daniel Benjamin, a Duke University researcher who helps distribute the scarce federal funds allocated to studying older pediatric drugs.
One Swedish study found that mice taking the drug for two weeks had impaired cell growth in the hippocampus, a brain region critical for memory and learning.
A 2022 study in Portugal found altered levels of dopamine and serotonin in rats, as well as lowered defenses against stress, said Gonçalo Justino, a biochemistry researcher at the University of Lisbon.
Dr. Marc Flajolet, a Rockefeller University neuroscientist, said evidence suggesting that the drug could affect developing brains meant that “it will be probably safer at this point not to use that in kids until we know more.”
The original article contains 3,327 words, the summary contains 195 words. Saved 94%. I’m a bot and I’m open source!
This is the best summary I could come up with:
The F.D.A.’s handling of Singulair illustrates systemic gaps in the agency’s approach to addressing troubling side effects from medicines approved long ago — and to warning the public and doctors when serious issues arise.
With concerns lingering, researchers, including some at the F.D.A., have returned to basic animal studies to examine possible effects of montelukast in the brain, a quest that could take a decade to complete.
Settling the question of how common the problems are remains unlikely, said Dr. Daniel Benjamin, a Duke University researcher who helps distribute the scarce federal funds allocated to studying older pediatric drugs.
One Swedish study found that mice taking the drug for two weeks had impaired cell growth in the hippocampus, a brain region critical for memory and learning.
A 2022 study in Portugal found altered levels of dopamine and serotonin in rats, as well as lowered defenses against stress, said Gonçalo Justino, a biochemistry researcher at the University of Lisbon.
Dr. Marc Flajolet, a Rockefeller University neuroscientist, said evidence suggesting that the drug could affect developing brains meant that “it will be probably safer at this point not to use that in kids until we know more.”
The original article contains 3,327 words, the summary contains 195 words. Saved 94%. I’m a bot and I’m open source!