Classification of Drugs for Pregnant Women As Per FDA

Pregnancy would usually make a woman start to think not only of herself but for her the life developing inside her womb. She would want to eat healthier, and be more conscious about her overall well-being to be able to provide a nourishing environment for her growing child. Each pregnant woman goes through varied conditions when carrying a baby. 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.

One such example is Zoloft, an antidepressant classified as a Selective Serotonin Reuptake Inhibitor (SSRI), which is now linked to certain 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 a pregnant woman is diagnosed to have clinical depression, they may be given certain classes of medication to treat it. 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.

A category C is given to Zoloft by the FDA where it believed that there are possible harm that may be caused from taking this drug but its benefits outweigh the risk. 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. That being said, your doctor is still the best person to consult regarding your treatment plan. You should raise these concerns and discuss them with your ob-gynecologist in order to address them appropriately.

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