Impact of Drugs on Pregnancy: Risks and Categories
Learn about the risks associated with using drugs during pregnancy and understand the FDA Pregnancy Risk Categories. Explore the potential harm to the fetus, ranging from minimal risk to serious abnormalities, and discover which medicinal products and substances to avoid during pregnancy to ensure a healthy outcome for the baby.
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Presentation Transcript
Drugs During Pregnancy Dr. Haider Raheem Mohammad Dr. Haider Raheem Mohammad
FDA Pregnancy Risk Categories CategoryA Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and 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 an 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 a risk in later trimesters). Category C Either study in animals has 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.
FDA Pregnancy Risk Categories Category D There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., 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 the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Medicinal products, chemicals and drugs of abuse with proven embryo/fetotoxic potential in humans Agent Alcohol Androgens Antimetabolites Benzodiazepines Carbamazepine Cocaine Coumarin anticoagulants Diethylstilbestrol Iodine overdose Lead Methyl mercury Indicating signs Fetal alcohol syndrome/effects Masculinization Multiple malformations Floppy infant syndrome Spina bifida, multiple malformations CNS, intestinal and kidney damage Coumarin syndrome Vaginal dysplasia and neoplasms Reversible hypothyroidism Cognitive developmental retardation Cerebral palsy, mental retardation
Medicinal products, chemicals and drugs of abuse with proven embryo/fetotoxic potential in humans Agent Misoprostol Penicillamine Phenobarbital/primidone (anticonvulsive dose) Phenytoin Polychlorinated biphenyls Indicating signs Moebius-sequence, reduction defects of extremities Cutis laxa Multiple malformations Multiple malformations Mental retardation, immunological disorders, skin discoloration Ear, CNS, cardiovascular, and skeletal disorders Discoloration of teeth Malformations of extremities, autism Multiple malformations Spina bifida, multiple malformations See retinoids Retinoids Tetracycline (after week 15) Thalidomide Trimethadione Valproic acid Vitamin A (>25,000 IU/day)
