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Zero Exposure Project, An Initiative of the Healthy Start Coalition of Hillsborough County Information & Services - Over the Counter Drugs
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Over the Counter (OTC) Drugs

If you develop a condition while you're pregnant that requires drug treatment, your provider should know how to select a therapy that minimizes risks to the fetus or embryo and maximizes your ability to get your health back to normal.

But before starting a medication, it's always a good idea to find out what kind of drug you are taking.

To guide you and your physician in selecting the safest drugs to use during pregnancy, the U.S. Food and Drug Administration developed five categories (A, B, C, D and X). Each letter reflects the level of risk associated with the use of that drug in pregnancy.

When your provider gives you a prescription or recommends an over-the-counter drug, make sure you ask which category the drug is in.

Drugs that fall into categories A, B and C are generally considered "safe" in pregnancy. Drugs in Category D have been shown to have potential adverse effects during pregnancy, but sometimes their potential benefit outweighs the risk. Generally, pregnant women should take Category D drugs only if there are no other choices.

Category X drugs, also known as "teratogens," are known to cause malformations in human embryos or fetuses, and there is usually no benefit to taking these drugs during pregnancy. Category X drugs are contraindicated for women who are contemplating pregnancy, as well as for women who are already pregnant. Only a few drugs -- such as thalidomide, alcohol and DES -- are in Category X.

FDA Pregnancy Categories for Drugs

Category A

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester, and there is no evidence of a risk in later trimesters. The possibility of fetal harm appears remote. Example: Vitamin C when used in recommended daily allowance dosage.

Category B

Animal studies have not demonstrated fetal risk but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect (other than a decrease in fertility), but adequate studies in pregnant women have not demonstrated a risk to the fetus during the first trimester and there is no evidence of risk in later trimesters). Example: Ampicillin.

Category C

Animal studies have shown an adverse effect on the fetus (teratogenic, embryocidal, or other) but there are no adequate studies in humans. The benefits from the use of the drug in pregnant women may be acceptable despite its potential risks, or there are no animal reproduction studies and no adequate studies in humans. Example: Zidovudine (AZT).

Category D

Positive evidence of human fetal risk exists, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (eg, for a life-threatening condition or a serious disease for which safer drugs cannot be used or are ineffective). Example: Phenytoin (anticonvulsive).

Category X

Studies in animals or humans demonstrate fetal abnormalities or adverse reaction reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit. Example: Isotretinoin (acne treatment)

 

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