Proven Human Teratogens

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Numerous drugs are associated with congenital malformation e.g. aminopterin/methotrexate, ACE-Inhibitors, antineoplastics, anti-thyroids, barbiturates, carbamazepine, cocaine, coumarin derivatives, diethylstilbesterol, ethanol (large dose), iodides, radioactive iodine, lithium, methadone, phenytoin, retinoid, vitamin A (>18,000 IU/day), tetracycline and valproic acid.



FDA categories (teratogenic risks of drugs):
Category A

Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester and the fetal harm appears remote.

Category B

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 that was not confirmed in controlled studies in women in the first trimester.

Category C

Studies in animals have revealed ad- verse effects on foetus and no controlled studies in women are available. Or, studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Category D

Evidence of human foetal risk is positive, but the benefits from use in pregnant women may be acceptable despite the risk.

Category X

Studies in animals or humans have demonstrated foetal anomalies or there is evidence of foetal risk based on human experience or both and the risk of the drug in pregnant women

clearly outweighs any possible benefits. The drug is contraindicated in women who are or may become pregnant.