Exposure to Paxil/Paxil CR (paroxetine HCl, GlaxoSmithKline) during the first trimester of pregnancy increases the risk for congenital malformations, especially cardiac malformations, according to the FDA. As a result, the manufacturer has changed Paxil's pregnancy category from C to D and added new recommendations to the prescribing information's Warnings section.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.