In 1979 the United States Food and Drug Administration (FDA) introduced drug classification categories of fetal risks due to pharmaceuticals. In 2005 the FDA asked the manufacturer of Paxil, GlaxoSmithKline (GSK), to reclassify Paxil from Pregnancy Class C to Pregnancy Class D. With the reclassification many women are beginning to think
if taking Paxil during pregnancy is really worth it.
Before the FDA asked GSK to reclassify Paxil it was in pregnancy category class C. Officially the FDA defines a drug that is pregnancy category class C as: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks."
Since the FDA request Paxil is currently pregnancy category class D. Officially the FDA defines a drug that is pregnancy category class D as: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
A new question arises with the class reclassification of Paxil which is if it will affect how the drug is prescribed to pregnant women. Since the drug is now classified as a potential risk to a developing fetus many women may stray from taking the drug as the potential risks may outweigh any positive effects the drug may have. The Potential risks of taking Paxil during the last trimester of pregnancy have been known to include: general irritability due to withdrawal from the medication, seizures or persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition. One instance in where Paxil may be prescribed to a pregnant woman is if the patient has already taken other antidepressants with no positive response.
Since GSK received a request from the FDA to change Paxils pregnancy category class from pregnancy category class from C to D many current users of the drug have begun to rethink using Paxil. The FDA requested reclassification may also change how the drug is prescribed to women who are pregnant or are looking to become pregnant because of possible Paxil birth defects. Consult with your doctor first if you are looking to start taking Paxil for your signs and symptoms of depression.
