Template:FDA historic drug class table - Revision history

Z8600021 at 06:34, 15 February 2018

2018-02-15T06:34:40Z

← Older revision		Revision as of 17:34, 15 February 2018
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	\| Category D		\| Category D
	\| There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).		\| There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
	\|-bgcolor="~~red~~"		\|-bgcolor="orangered"
	\| Category X		\| Category X
	\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.		\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
	\|}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Drugs]][[Category:Abnormal Development]]</noinclude>		\|}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Drugs]][[Category:Abnormal Development]]</noinclude>

Z8600021 at 06:34, 15 February 2018

2018-02-15T06:34:07Z

← Older revision		Revision as of 17:34, 15 February 2018
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	\| Category A		\| Category A
	\| Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of a risk in later trimesters, and the possibility of fetal harm appears remote.		\| Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of a risk in later trimesters, and the possibility of fetal harm appears remote.
	\|-		\|-bgcolor="F5FAFF"
	\| Category B		\| 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 on 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).		\| 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 on 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).
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	\| Category C		\| 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.		\| 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.
	\|-		\|-bgcolor="F5FAFF"
	\| Category D		\| Category D
	\| There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).		\| There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
	\|-		\|-bgcolor="red"
	\| Category X		\| Category X
	\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.		\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
	\|}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Drugs]][[Category:Abnormal Development]]</noinclude>		\|}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Drugs]][[Category:Abnormal Development]]</noinclude>

Z8600021 at 06:29, 15 February 2018

2018-02-15T06:29:20Z

← Older revision		Revision as of 17:29, 15 February 2018
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	\| Category X		\| Category X
	\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.		\| Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
	\|}		\|}<noinclude>[[Category:Template]][[Category:Table]][[Category:Historic Embryology]][[Category:USA]][[Category:Drugs]][[Category:Abnormal Development]]</noinclude>

	~~{{FDA historic drug class collapsetable}}~~

Z8600021: Created page with "{| ! colspan=2|US FDA - Historic Drug Categories (pre-2015) |-bgcolor="CEDFF2" ! width=100px|Category ! width=600px|Description |- | Category A | Controlled studies in women f..."

2018-02-15T06:27:27Z

Created page with "{| ! colspan=2|US FDA - Historic Drug Categories (pre-2015) |-bgcolor="CEDFF2" ! width=100px|Category ! width=600px|Description |- | Category A | Controlled studies in women f..."

New page

{|
! colspan=2|US FDA - Historic Drug Categories (pre-2015)
|-bgcolor="CEDFF2"
! width=100px|Category
! width=600px|Description
|-
| Category A
| Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, there is no evidence of a 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 on 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 (eg, if the drug is needed in a life-threatening situation or for a serious disease for 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 or both, and the risk of use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
|}

{{FDA historic drug class collapsetable}}