From Pharmacy Drug Guide
Women who are pregnant or who are considering becoming pregnant may need to work with their doctors to reevaluate the drugs they're currently taking. Often, this process begins by looking at the medication's pregnancy category. Drugs are assigned a pregnancy risk factor category ranging from A through E, and sometimes X, by the Food and Drug Administration, depending on what has been learned about the drug through animal and human studies. In some instances. when the drug is not administered systemically—as with a topical cream—or it is shown not to cause fetal harm, manufacturers may not include pregnancy risk information on the product label or insert.
|FDA Phone Number||888-INFO-FDA (1-888-463-6332)|
|FDA Division of Drug Information||301-796-3400|
|FDA Drug Information for Women||301-796-9440|
|Possible Risks to Fetus||Heart defects, congenital malformations|
|Pregnancy Risk Factors, increased miscarriage risk||Cateory A, B, C, D, E, and X|
|Disclaimer||The information provided by PharmacyDrugGuide is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician.|
FDA Pregnancy Risk Factor Categories
- Category A: Controlled studies in women failed to demonstrate a risk to the fetus in the first or subsequent trimesters. Possibility of fetal harm seems remote.
- Category B: Animal reproduction studies have not demonstrated fetal risk, and there are no adequate human studies OR animal studies have demonstrated adverse effects, but human studies have not demonstrated fetal risk.
- Category C: Animal studies have demonstrated adverse fetal effects, but there are no adequate human studies. Benefits to the mother may outweigh potential risks to the fetus.
- Category D: Positive evidence of human fetal risk is demonstrated in human studies or post-approval data, but benefits to the mother may outweigh potential risks to the fetus, and safer drugs cannot be used or are ineffective.
- Category E: Animal or human studies demonstrated fetal abnormalities, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
- Category X: Strong evidence that the drug causes birth defects, either in humans or in animals, and fetal risks outweigh any possible benefit.
Drugs and Breastfeeding
The FDA also requires drug manufacturers to document what is known about whether a drug is excreted in human or animal milk, and if it is, known effects on the nursing infant must be described. Possible recommended options include:
- Continuing the drug while breastfeeding
- Discontinuing nursing
- Discontinuing the medication while nursing
- Adjusting the schedule of drug administration relative to expected breastfeeding times
Medications that do not have known adverse effects on nursing infants will carry the warning "Caution should be exercised when (drug name) is administered to a nursing woman."
Pregnancy and Prescription Drugs
The risk to the fetus when the mother takes medications during pregnancy varies according to drug, dosage and individual tolerance. Certain drugs, such as Accutane® and Thalamid®, are known to cause serious defects and are therefore never prescribed during pregnancy. With other medications, such as anti-seizure drugs and antidepressants, the risk of taking the drug may sometimes be outweighed by the health risk to both the mother and fetus upon discontinuation. In some cases, doctors may lower the dosage to minimize the potential for fetal harm.
Pages in category "Drugs and Pregnancy"
The following 72 pages are in this category, out of 72 total.