Paxil® During Pregnancy

Due to the recent Paxil® studies indicating Paxil®'s harmful effects to a developing fetus, the FDA asked Glaxo Smith Kline to change the pregnancy category from C to D. Category D means that a drug is more damaging than one in Category C. Teratogens refer to anything that can harm an embryo or fetus, and they may include drugs. For a more thorough understanding of pregnancy drug categories, please see below.

  • Category A
    Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters), and the possibility of fetal harm appears remote.
  • Category B
    Either animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of risk in later trimesters).
  • Category C
    Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
  • Category D
    There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease in which safer drugs cannot be used or are ineffective).
  • Category X
    Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

 

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Get Legal Help Today
If you or a loved one used Paxil® while pregnant and your child was born with a birth defect, a Paxil® lawsuit may be a possibility. Contact Morelli Ratner P.C. for a free legal consultation today. Call 1 (877) 415-3102 or fill out our form at the right.