FDA Adds Paxil SSRI to Category D Pregnancy Drug

Paxil aka Paroxetine HCL are SSRI (Selective Seratonin Reuptake Inhibitor) antidepressants marketed by GlaxoSmithKline. Paxil has been upgraded by the FDA to a category D pregnancy drug. Heart and lung birth defects are linked to Paxil. PPHN, or Perisistant Pulmonary Hypertension in the Newborn, ASD (Arterial Septal Defect) and VSD (Ventricular Septal Defect) are other birth defects that have been discovered far more frequently in infants born to mothers who were taking Paxil (Paroxetine HCL) during pregnancy.

This FDA upgrade is hugely significant as Category D pregnancy drugs are the most dangerous drugs to the developing fetus, next to Category X.  TheAmerican Pregnancy website lists the FDA definition of Category D pregnancy drugs in this way:

Positive evidence of Risk. Studies in humans and or post marketing data have demonstrated fetal risk. Potential benefits from the use of the drug may outweigh the potential risk however. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.'

Drugs like the tetracycline acne drugs are also category D pregnancy drugs. Paxil and Paroxetine are category D and not category X drugs (like thalidomide and Accutane) due to a myth that the life of the mother is in danger in some way if she stops taking Paxil in pregnancy. Women on antidepressants are often told that to stop taking their Paxil during pregnancy might harm baby, too. So mothers chose what seemed to be the lesser of two evils.

Another issue with the Category D pregnancy drug rating is that it assumes that no safer antidepressants or SSRIs are available. That's simple not true. There are safer antidepressants women can take. Whether an antidepressant or SSRI is necessary for the health of the mother is debatable. If the drug is a danger to the fetus in any way is information women need in order to be able to make informed decisions. For more on drugs, health and pregnancy, visit me at Health Help 4u

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