Heart Birth Defect Warnings and Alerts
Category C Warning
The Food and Drug Administration uses a pregnancy category system that classifies risk to a fetus when medication is taken during pregnancy. The FDA initially declared SSRI antidepressants as pregnancy “category C” drugs. This category means that the particular medicine has not been studied in pregnant women, but side effects to the fetus were found in animal studies. The pregnancy categories measure the teratogenic effects a drug has on a fetus. Teratogenic means that a drug or other substance is capable of interfering with the development of a fetus.
Heart Birth Defect Public Health Advisory
The Food and Drug Administration issued a Public Health Advisory in 2005 declaring that certain SSRI antidepressants may increase the risk for congenital cardiac defects when taken during the first trimester of pregnancy. The alert was prompted by studies showing the rise in risk of heart malformations, particularly septal heart defects (such as atrial or ventricular septal defects) when mothers took certain SSRIs during their pregnancy. The FDA recommended that physicians caring for women taking certain SSRI antidepressants “should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in the first trimester of pregnancy.”
Alliance for Human Research Protection
The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected.
Harvard / Stanford -- Psychiatry's Opinion Leaders Financial Ties to Industry
AHRP highlights two investigative reports in the Wall Street Journal and the Mercury News that explain how “opinion leaders” linked to antidepressant manufacturers influence how mental health patients are treated.
Safety of Newborn infants Threatened by Rx Antidepressants During Pregnancy
In this AHRP alert, we learn that The New England Journal of Medicine has found that the use of SSRI antidepressants taken during pregnancy poses a serious risk of pulmonary hypertension in newborns (PPHN).