Paxil CR Labeling Adds New Data On Birth Defects; GSK Plans Further Studies
Executive Summary
GlaxoSmithKline is conducting additional epidemiologic studies to better understand preliminary data suggesting a potential link between paroxetine use and birth defects, the company said in a "Dear Doctor" letter on revised labeling for Paxil CR and Paxil
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SSRIs not cause of birth defects
No significant association between use of selective serotonin-reuptake inhibitors in early pregnancy and congenital heart defects or most other birth defects was detected in a pair of case-control surveillance studies published in the June 28 issue of the New England Journal of Medicine. Results from the Slone Epidemiology Center Birth Defects Study found no significant increases in certain birth defects for the antidepressant class, but the findings "suggest that individual SSRIs may confer increased risks for some specific defects," although "the absolute risks are small." The Slone study found an association between sertraline (Pfizer's Zoloft and generics) and omphalocele and septal defects and between paroxetine (GlaxoSmithKline's Paxil and generics) and right ventricular outflow obstruction defects. Language regarding congenital malformations was added to Paxil labeling in 2005, and GSK is conducting its own epidemiologic studies examining the potential for birth defects (1"The Pink Sheet" Oct. 3, 2005, p. 10)...
SSRIs not cause of birth defects
No significant association between use of selective serotonin-reuptake inhibitors in early pregnancy and congenital heart defects or most other birth defects was detected in a pair of case-control surveillance studies published in the June 28 issue of the New England Journal of Medicine. Results from the Slone Epidemiology Center Birth Defects Study found no significant increases in certain birth defects for the antidepressant class, but the findings "suggest that individual SSRIs may confer increased risks for some specific defects," although "the absolute risks are small." The Slone study found an association between sertraline (Pfizer's Zoloft and generics) and omphalocele and septal defects and between paroxetine (GlaxoSmithKline's Paxil and generics) and right ventricular outflow obstruction defects. Language regarding congenital malformations was added to Paxil labeling in 2005, and GSK is conducting its own epidemiologic studies examining the potential for birth defects (1"The Pink Sheet" Oct. 3, 2005, p. 10)...
Paxil CR Labeling Adds Birth Defects Warning Based On U.S., Swedish Data
FDA deemed a birth defects warning for GlaxoSmithKline's Paxil CR to be warranted after data from a Swedish birth registry supported an analysis of a U.S. managed care claims database, the agency said