Antidepressant Birth Defects Warnings & Alerts

The use of antidepressants, such as Celexa and Lexapro, have been at the center of heated debate due to growing concerns over potential adverse reactions, including serious birth defects.

The Food and Drug Administration (FDA):

Category C

The FDA uses a pregnancy category system to classify potential risk to a fetus when medication is taken during pregnancy. The FDA has declared the majority of SSRI antidepressants, a pregnancy “Category C” drug. This pregnancy category means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate well-controlled studies in humans. 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.

"In some ways, tort litigants may be in a better position than the FDA to keep drug companies honest, since they sometimes see evidence that the agency doesn't." -- The National Law Journal wrote about Baum Hedlund.

Congenital Heart Defects

The FDA issued a Public Health Advisory on December 8, 2005 warning that use of certain antidepressants during the first trimester of pregnancy could potentially increase the risk of infant heart birth defects. According to the FDA, several studies indicate that exposure to certain SSRI antidepressants in the womb increases the risk of cardiac defects in newborns. The studies mainly focused on atrial and ventricular septal defects, potentially life threatening conditions in which the wall between the right and left sides of the heart is abnormal.

PPHN

On July 19, 2006, the FDA issued a Public Health Advisory concerning SSRI antidepressants such as Celexa, Lexapro and Zoloft, based on a study published in the New England Journal of Medicine (NEJM) that found a six fold increased risk of persistent pulmonary hypertension (PPHN) in infants born to mothers who took an antidepressant in the last trimester of pregnancy. PPHN is a life threatening congenital disorder in which an infant’s arteries to the lungs remain constricted after delivery, limiting the amount of blood flow to the lungs and therefore the amount of oxygen into the bloodstream.

Health Canada:

Adverse Effects with Third Trimester Use

On August 9, 2004, Canada’s national public health department, Health Canada, released an advisory warning the public of a number of possible adverse effects to newborns whose mothers took antidepressants during the last trimester of pregnancy. According to the advisory, newborns whose mothers took antidepressants during pregnancy have developed “complications at birth requiring prolonged hospitalization, breathing support and tube feeding.  Reported symptoms include: feeding and/or breathing difficulties, seizures, muscle rigidity, jitteriness and constant crying.” Health Canada explained that the symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug.” The agency urged pregnant women to “carefully consider the potential risks and benefits of the various treatment options for both the mother and the unborn baby.

Consumer Advocates:

Alliance for Human Research Protection

Harvard / Stanford–Psychiatry’s Opinion Leaders Financial Ties to Industry

Below is an Excerpt from a July 12, 2006 article by the Alliance for Human Research Protection (AHRP), a consumer advocacy network dedicated to advancing ethical medical research practices.

David Armstrong of the Wall Street Journal documents violations of medicine’s foremost ethical principle, “first, do no harm,” by influential academic psychiatrists who promote psychotropic drugs for pregnant women that will cause harm to their developing infants.   Specifically, thirteen leading industry-financed psychiatrists from Harvard, UCLA and Emory, published a report in JAMA (2006) whose aggressive promotion in the local and national media was designed to frighten pregnant women and to dissuade them from stopping antidepressants during pregnancy.

The authors emphasized a (previously unreported) risk of relapse, disregarding a body of evidence (documented since 1993) demonstrating that exposure to serotonin (SSRI antidepressants) in utero has caused birth defects, cardiac malformation, respiratory distress, and severe withdrawal syndrome in infants…

… JAMA’s failure to enforce its conflict of interest disclosure policy raises serious questions about the journal’s role as a promoter of industry’s marketing agenda rather than a gatekeeper protecting the integrity of scientific and ethical standards in research.

Alliance for Human Research Protection

Safety of Newborn infants Threatened by Rx Antidepressants During Pregnancy

This February 9, 2006 article by the Alliance for Human Research Protection discusses drug safety accountability:

 Psychiatry ought to be held accountable for making false claims about drug safety. There ought to be a law prohibiting licensed professionals from prescribing hazardous [sic] substances to pregnant [sic] women and children–without even informing them about the documented risks the drugs pose.Even an examination of the risks disclosed by manufacturers in these drugs’ labels should have raised alarm bells about widespread prescribing of antidepressants–especially for children and pregnant women whose intake of toxic substances injures their yet to be born infants.  

To make an informed decision, one must weigh the potential benefits against the risks. To do so, one must know what the relative risks are.