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Updated: Aug 21, 2026

Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Risk of drug-induced congenital defects
Marco De Santis1, Gianluca Straface, Brigida Carducci
1Telefono Rosso-Teratology Information Service, Institute of Obstetrics and Gynaecology, Catholic University Sacred Heart, Largo A. Gemelli 8, Rome 00168, Italy. marcodesantis@rm.unicatt.it
Abstract:
Defects attributable to drug therapy represent about 1% of congenital defects of known aetiology. This means that a precautionary attitude and correct use of drugs in fertile, and especially pregnant, women is a feasible form of prevention. Drugs currently in use with proven teratogenic effect number approximately 25, but new pharmaceutical drugs are constantly in preparation. Recognition of a drug-induced teratogenic effect is a complex procedure taking into account not only experimental animal data but also experience in humans. Considering that 40% of pregnancies are not planned, it follows that any drug with known or suspected teratogenic potential must be used only under strict medical control. Also, adequate knowledge on potential teratogenicity of a drug permits modification of therapy before conception. It goes without saying that any drug should be used during pregnancy only if it is essential, and it would be prudent to use only those where adequate information is provided and prior clinical experience is available. Teratology Information Services can assist both physicians and patients when any doubt exists.
Insights
Preventing drug-induced birth defects involves cautious medication use in women of childbearing potential. Strict medical supervision and knowledge of drug teratogenicity are crucial for safe pregnancy outcomes.
Area of Science:
- Medical Science
- Pharmacology
- Teratology
Background:
- Drug therapy accounts for approximately 1% of congenital defects with known causes.
- A significant number of pregnancies are unplanned, highlighting the need for proactive measures.
- The number of drugs with known teratogenic effects is substantial, with ongoing development of new pharmaceuticals.
Purpose of the Study:
- To emphasize the importance of a precautionary approach to drug use in women of reproductive age.
- To underscore the complexity in recognizing drug-induced teratogenic effects.
- To advocate for informed medication management during pregnancy and preconception.
Main Methods:
- Review of existing data on drug-induced teratogenicity.
- Consideration of both animal experimental data and human experience.
- Highlighting the role of Teratology Information Services.
Main Results:
- Approximately 25 drugs currently have proven teratogenic effects, with more in development.
- Recognition of teratogenicity requires a multifaceted approach, integrating diverse data sources.
- Strict medical control is essential for drugs with known or suspected teratogenic potential, especially in unplanned pregnancies.
Conclusions:
- Judicious drug use in fertile and pregnant women is a viable preventive strategy for congenital defects.
- Informed therapeutic decisions, including pre-conception therapy modification, are vital.
- Prioritizing essential medications with available clinical data and utilizing Teratology Information Services can mitigate risks.
Related Concept Videos
Teratogenicity
Drug Toxicity: Risk factors
Factors Affecting Drug Response: Overview
Drug toxicity: Idiosyncratic Reactions
Drug Toxicity: Dose-Dependent Reactions
Pharmacokinetics in Pediatric Patients: Drug Excretion

