GSK Requested to Change Paxil Pregnancy Class Category Due to Paxil Birth Defects

Drug classification categories of fetal risks due to pharmaceuticals were introduced in 1979 by the United States Food and Drug Administration (FDA).It was requested in 2005 by the FDA that the manufacturer of Paxil, GlaxoSmithKline, reclassify Paxil from Pregnancy Class C to Pregnancy Class D. The reclassification of Paxil has caused many women to begin to think .

When the FDA asked GSK to reclassify Paxil it was in pregnancy category class C. According to the FDA a pregnancy category class C drug is defined 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.”

Afterwards Paxil is now currently in pregnancy 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. Now that Paxil is 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. Some of the potential risks of taking Paxil during the final three months of pregnancy may include: general irritability due to withdrawal from the medication, seizures or persistent pulmonary hypertension (PPHN), a serious and life-threatening lung condition. However, an instance in where Paxil may be prescribed to a pregnant woman is if the patient has already taken other antidepressants with no positive response.

The FDA’s request to GSK to reclassify Paxil from pregnancy category class C to pregnancy category D may have caused many current users of Paxil to rethink using the drug. The reclassification may also change how the drug is prescribed to women who are pregnant or are looking to become pregnant because of possible . If you are looking to take Paxil for your signs and symptoms of depression, consult with your doctor first. t.

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