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Fda ApprovedPregnant Women Learn FDA Pregnancy Category
A pregnant woman usually starts thinking not only for herself but for the child she's carrying inside of her as well. 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. 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 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.
Zoloft is classified by the FDA as a category C medicine where it could possibly cause harm to the developing fetus but its benefits are said to outweigh its risks. Note that drugs under this category were not tested on any pregnant human female. Recently, studies reveal that several birth defects is caused by taking Zoloft during pregnancy. 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. FDA approves PROGENSA PCA3 assay