Substance classification according to
with danger for pregnancy

CATEGORY

A

Controlled studies in women failed to demonstrate fetal risk in the first trimester (and there is no evidence of risk in subsequent trimesters).

Animal reproduction studies have not shown fetal risk but there are no controlled studies in pregnant women.

CATEGORY

B

CATEGORY

C

Or animal studies have shown adverse reactions in fetuses and there are no adequate controlled studies in humans, but the benefits may justify use in pregnant women despite the potential risks.

There is evidence of human fetal risk based on adverse events from experimental animal studies, clinical studies or market data, but the benefits may justify use in pregnant women despite the potential risks.

CATEGORY

D

CATEGORY

X

Animal or human studies have shown fetal abnormalities or there is evidence of fetal risk based on experience of use in humans or both, and the risk of use in pregnant women is clearly greater than any possible benefit.

Pregnancy and Lactation Labeling Rule (PLLR - FDA)

Considering the difficulty of weighing the risk / benefit balance in drug selection for pregnant women, the FDA revised the standards and excluded for some product categories the need to rank ("Class X", for example).

In addition, specific information on the effects observed should be included in the package leaflet, and the item "Risks to Pregnancy" should be grouped together with substances that interfere with labor, while the item "breastfeeding mothers" has been converted to "lactation".

A specific item was also inserted to include information on other effects on reproduction, such as those effects that may for example alter fertility rates in both men and women.

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