FDA pregnancy categories

      FDA pregnancy categories;

   Category A

    Control studies in women fail to demonstrate risk in first trimester ( and there is no                evidence of risk in later trimester) and possibility of fetal harm appears remote.                   Example

•     Thyroid hormone
•      Folic acid
•      Pyridoxine
•     Category B

  Category B

   Animal reproduction studies have not demonstrated fetal risk but there are no controlled       studies in pregnant women. Animal reproduction studies have shown adverse effect that       was not confirmed in controlled studies of women in first trimester, There is no evidence       of risk in later studies.

   Example;

•    Metronidazole
•    Famciclovir
•    Famciclovir
•    clindamycin
•     didanosine
•     acyclovir

  Category C 

   Studies have shown adverse effect on fetus and there are no controlled studies on                   women. In some cases, studies in women and animal are not available. Drugs in this             category should be given only if potential benefit justifies risk to fetus.

    Example;

•    Ciprofloxacin
•    Corticosteroids
•    Foscarnet
•    Indinavir
•    dronabinol
•    filgrastim

  Category D

   There is positive evidence of human fetus risk, but the benefit of pregnant women may         be  acceptable beside the risk, as in life threatning disease for which safer dud cannot be       used or are in effective. An appropriate statement must appear in the warning section of         the labelling of the drug in this category.

   Example;

•    cytarabine
•    daunorubicin
•    etoposide
•    bleomycin

  Category X;

   studies in animals and humans have demonstrated fetal abnormalities and adverese               reaction reports indicate evidence of fetal risk. The risk of using the drug in pregnant             woman out-weighs any possible benefit. The drug is contraindicated in woman who may       become pregnant.

   Example

•    Cyclophosphamide
•     Megestrol
•     Thalidomide
•     Ribavirin

What are FDA  pregnancy categories?

Is category D safe during pregnancy?

What is category A medication in pregnancy?