Question

write an essay on the FDA pregnancy categories of teratogenic drugs include the category and the interpretation. give at least one example of drug for each category

Answer 1

In the year of 1979 , Food and drug Administration develped a system, which determines the teratogenic effects of drugs by considering the quality data from animal and human studies.

According to FDA there are 5 pregnancy catogories in teratogenic drugs.

A , B , C , D and X.

A: catogory A indicates no risk demonstrated in human studies.

A number of studies took place in the past and they were failed to demonstrate a risk to the fetus in any of the trimesters.

Examples:

*vitamines B, C, D, E

*folic acid

*thyroxin

B: no risk in other studies.

Animal studies also performed , but failed to demonstrate any adverse effects to fetus .

Examples:

*acetaminophen

*phenacetin

*antiemetics

*doxylamine

*erythromycin

*anthelmentics

*ethambutol

C: in category C, risk is not ruled out. Studies performed in animals have shown adverse effects on fetus. And there are no adequate and well controlled studies in humans.

Examples:

* aspirin

*gentamicin

*amikacin

*antimalarials

*antifungals

*rifampicin

*pyrazinamide

D: In catogory D, there is a positive evidence of risk.

Studies performed in human being was able to demonstrate adverse effects in fetus. But potential benefits may warrant use of the drug in pregnant women despite potential risks.

Examples:

*amikacin

*sulfanamides

*tetracyclines

*streptomycin

*medroxyprogesteron

X: contraindicated in pregnancy.

Studies performed in both animals and human have demonstrated number of fetal abnormalities. And the risk involved in use of drug in pregnant women clearly outweigh potential benefits.

Examples:

*androgens

*estrogens

*norethindrone

*bronchodilators