Psychotropic medications are associated with adverse drug reactions (ADRs), many of which are serious, in children younger than 17 years, according to a new database study from Danish researchers. Results also showed that all but one of the psychotropic-related ADRs for children between the ages of birth and 2 years were serious, including birth defects such as neonatal withdrawal syndrome, ventricular septal defects, and premature labor.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency in the UK responsible for medicines and medical devices, has issued a warning about potential SSRI birth defects related to the use of fluoxetine (Prozac). The MHRA issued the warning in its monthly drug safety update. The agency warns that there is a small risk of congenital cardiac defects in infants of mothers who took fluoxetine during the first trimester of pregnancy.