BIG PHARMA WINS AGAIN –
Jan. 9, 2024 – Ashley and Chris Bracken, Genevieve’s parents, in Genevieve’s bedroom. Ms. Bracken said she and her husband learned more about their daughter’s mental state after her death. (NYT) Nicole Sims, whose son experienced nightmares and hallucinations while on the drug, and other parents like her have only learned of these risks through online support groups, NOT from their doctors.
Nicole Sims, whose son experienced nightmares and hallucinations while on the drug, and other parents like her have only learned of these risks through online support groups, NOT from their doctors. The FDA’s approach has been criticized for initially dismissing evidence of brain-injury side effects during Singulair’s approval process in 1998. There have been numerous reports of psychiatric problems, but Merck, the drug’s original manufacturer which sold the drug to Organon in 2021, denies a significant link between Singulair and neuropsychiatric events. The FDA’s monitoring system largely relies on drugmakers to report problems, a process that may not provide a complete picture of the risks.
Studies on the drug’s psychiatric side effects have shown variations in their frequency and presence, leading to inconclusive results. The FDA continues to investigate these concerns, including studying animal models to understand the drug’s effects on the brain.
