How The FDA Classifies Drugs Used by Pregnant Women
When a woman gets pregnant, she usually starts to think not only for herself but for the new life growing inside her as well. To ensure that she’s giving a proper environment for her baby to grow in, she might start eating healthier and be more conscious about her total well-being. But not every pregnant woman go through the same conditions when carrying a child. Some experience minor health concerns which can be alleviated by proper diet and exercise while others need medication to address the underlying health issues that could affect both mother and child.
An example of this would be Zoloft, an antidepressant drug that falls under the classification, Selective Serotonin Reuptake Inhibitor (SSRI), which is reported to be associated with Zoloft congenital heart defects. Drugs under this SSRI classification prevent the re-absorption of serotonin, a compound that acts as a neurotransmitter that helps maintain a person’s feeling of wellbeing. This action tends to counteract negative emotions that goes with mood disorders and depression.
When diagnosed with clinical depression, patients, even pregnant ones are given medication by their doctors. The United States Food and Drug Administration (FDA) classifies these drugs used by pregnant women under a pregnancy category to determine their safety.
FDA Pregnancy Category(taken from the FDA’s official site)
Category A
There is no demonstration of a significant risk to the fetus in the first trimester as well as in the later trimesters of pregnancy according to studies.
Category B
There are no adequate studies in pregnant women but animal reproduction tests and observations have failed to establish a risk to the growing fetus.
Category C
Animal reproduction studies revealed some adverse effects on the fetus and there are no studies in human but the potential benefits justify the use of the medication in pregnant women in spite of the potential risks.
Category D
Evidence of human fetal risk is positive as per the adverse reaction data from investigational or marketing experience or studies in humans but still, potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X
Adequate and well-observed studies in animals and/ or humans have demonstrated abnormalities in the fetus and/or there is positive evidence of human fetal risk basing on the adverse reaction data from investigational or marketing experience, and the dangers involved in the use of the drug in pregnant women greatly outweigh potential benefits.
The FDA classifies Zoloft as a category C medicine where harm could be inflicted on the developing fetus but it is believed that the benefits are more substantial that its potential risks. Note that drugs under this category were not tested on any pregnant human female. Recent studies have it that taking Zoloft while pregnant could cause several birth defects on the newborn. Your doctor is still the best person to talk to regarding these matters. You should raise these concerns and discuss them with your ob-gynecologist in order to address them appropriately.