SSRIs Will Add Fetal Risk Information To Labeling
This article was originally published in The Pink Sheet Daily
FDA is seeking additional information about the possible risk of persistent pulmonary hypertension in newborns.
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FDA is seeking data on how often antidepressants are used by pregnant women to help gauge the significance of the findings.
Preliminary results from a retrospective epidemiologic study suggest an increased risk of congenital malformations associated with the use of paroxetine by pregnant women over other antidepressants, the letter states.
The dual GLP-1/GIP agonist outpaced Novo's blockbuster GLP-1 analogue at all three doses, including the important low dose, on A1C reduction and weight reduction in patients with type 2 diabetes.