Box 372

FDA Classification System

The following table represents the five category systems used by the FDA to classify drugs based on their potential for causing birth defects.

A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.

li 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).

C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal, or other) and there are not 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.

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).

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 contraindicated in women who are or may become pregnant.

bitewing, panoramic, or selected periapical films are indicated.

Medications. Drug therapy in the pregnant patient is controversial because drugs can affect the fetus by diffusion across the placenta. Prescriptions should be only the duration absolutely essential for the pregnant patient's well-being and only after careful consideration of potential side effects. I he classification system established by the I DA in 1979 to rate fetal risk levels associated with many prescription drugs provides safety guidelines (Box 37-2). Ihe prudent practitioner should consult references such as briggs' Drugs in Pregnancy and Lactation11 or Olin's Drag l-acts anil (.ornparisonsuA tor information on the I DA

pregnancy risk factor associated with prescription drugs. Ideally, no drug should be administered during pregnancy, especially Ihe lirst trimester.1 However, il is sometimes impossible to adhere to this rule. It is therefore fortunate that most commonly used drugs in dental practice can he given during pregnancy with relative safety, although there area few important exceptions (see lables 37-1 to 37-3). The table of drugs presented is considered a general guideline. Refer to the tables regarding local anesthetic, antibiotic, and analgesic prescriptions. In particular, antibiotics are often needed in periodontal therapy. Note that the effect of a particular medication on the fetus depends on the type ol antimicrobial, dosage, trimester, and duration of the course of therapy. " Research regarding subgingival irrigation and local site delivery in relation to the developing fetus is inadequate at this date.

Breast Feeding. Usually, there is a risk that the drug can enter breast milk and he transferred to the nursing infant, in whom exposure could have adverse effects (see Fables 37-4 and 37-5). Unfortunately, there is little conclusive information about drug dosage and effects via breast milk; however, retrospective clinical studies and empiric observations coupled with known pharmacologic pathways allow recommendations to be made.1 The amount of drug excreted in breast milk is usually not more than 1% to 2% of the maternal dose; therefore it is highly unlikely that most drugs have any pharmacologic significance for the infant.KS'M

I he mother should take prescribed drugs |cist after breastfeeding and then avoid nursing for 4 hours or more, if possible,1 ss to markedly decrease the drug concentration in breast milk.

New Mothers Guide to Breast Feeding

New Mothers Guide to Breast Feeding

For many years, scientists have been playing out the ingredients that make breast milk the perfect food for babies. They've discovered to day over 200 close compounds to fight infection, help the immune system mature, aid in digestion, and support brain growth - nature made properties that science simply cannot copy. The important long term benefits of breast feeding include reduced risk of asthma, allergies, obesity, and some forms of childhood cancer. The more that scientists continue to learn, the better breast milk looks.

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