Author Interviews, Autism, OBGYNE, Pain Research, Pediatrics / 23.09.2025
Tylenol in Pregnancy: Statement from Harvard T.H. Chan School of Public Health Dean
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Dr. Baccarelli[/caption]
Statement from Andrea Baccarelli, MD, PhD
Dean of the Faculty
Professor of Environmental Health
Harvard T.H. Chan School of Public Health
Colleagues and I recently conducted a rigorous review, funded by a grant from the National Institutes of Health (NIH), of the potential risks of acetaminophen use during pregnancy. We reviewed 46 previously published human studies worldwide.
We found evidence of an association between exposure to acetaminophen during pregnancy and increased incidence of neurodevelopmental disorders in children. This association is strongest when acetaminophen is taken for four weeks or longer.
Dr. Baccarelli[/caption]
Statement from Andrea Baccarelli, MD, PhD
Dean of the Faculty
Professor of Environmental Health
Harvard T.H. Chan School of Public Health
Colleagues and I recently conducted a rigorous review, funded by a grant from the National Institutes of Health (NIH), of the potential risks of acetaminophen use during pregnancy. We reviewed 46 previously published human studies worldwide.
We found evidence of an association between exposure to acetaminophen during pregnancy and increased incidence of neurodevelopmental disorders in children. This association is strongest when acetaminophen is taken for four weeks or longer.
Dr. Casale[/caption]
Thomas B. Casale, M.D.
Professor of Medicine and Pediatrics
Chief of Clinical and Translational Research
Division of Allergy and Immunology
USF Health Morsani College of Medicine
University of South Florida
Tampa, Florida
MedicalResearch.com: What is the background for this study?
Response: The data leading to FDA approval of neffy came from extensive pharmacokinetic and pharmacodynamic studies. As with previous epinephrine delivery devices, the FDA asked for data showing that after delivery of neffy the epinephrine blood levels and expected changes in pulse and blood pressure were similar to those achieved with injectable formulations of epinephrine. neffy performed as expected with blood levels of epinephrine bracketed by those achieved with EpiPen and a needle and syringe along with increases in pulse and blood pressure compatible with the epinephrine levels measured.
Additionally, clinicians are interested in whether neffy would perform similarly in real clinical situations. The data from the neffy experience program provides real-world assurance that neffy can effectively treat acute allergic reactions. Given the large number of patients and the similar findings to those achieved with injectable epinephrine in previous studies, the data should provide assurance that neffy can be an effective substitute for injectable epinephrine in patients that desire a needle-free option.
Maria Tan[/caption]
MedicalResearch.com:
Maria Y. Tian, MBS
Department of Medical Education
Geisinger College of Health Sciences
Scranton, Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: Schizophrenia-spectrum disorders are severe, disabling conditions that are associated with substantial economic burden. Approximately one-third of patients have treatment-resistant schizophrenia, which clozapine is the only evidence-based therapy for. Clozapine also provides unique benefits, including reduced suicide risk, aggression, and all-cause mortality. Despite this, it has historically been underutilized due to concerns over adverse effects, required blood monitoring, patient adherence, and limited clinician training. Previous research in Medicaid populations had demonstrated marked state-level variation in use, but little was known about prescribing trends in the U.S. Medicare system, which covers nearly half of individuals with schizophrenia. This study analyzed Medicare Part D data from 2015–2020 to assess national and regional trends in clozapine prescribing and to identify states with significantly different prescribing patterns.
