Physicians are often reluctant to prescribe dermatologic drugs to pregnant and lactating women, since this type of treatment is often considered elective rather than life-saving. Despite opinions and advisories disseminated by various organizations, scientists and manufacturers, no one database provides definitive guidelines on the exact risks associated with drug use during pregnancy and lactation. Data from birth defect registries are inconclusive as a result of the small numbers of reported cases, the low frequencies of exposure to certain drugs and the concern that findings may not be extrapolated to all populations. Reed evaluated dermatologic drugs with a low known risk in pregnant and lactating women.
More than 30 years ago, the U.S. Food and Drug Administration (FDA) devised regulations for drug use during pregnancy. These regulations became known as the Pregnancy and Lactation Categories. These categories are graded, balancing fetal risk against potential benefits to the mother. Drugs in FDA categories A and B pose either no risk or minimal risk, respectively. Category C drugs are those in which risk to humans cannot be ruled out. Topical nystatin was the only category A drug found. Since category B drugs are not without risk, informed consent should be obtained before prescribing these drugs during pregnancy. Another source of information, the Teratogen Information Service (TERIS), rates drugs according to exposure risk to the fetus or infant (none, minimal, moderate and high).
Patients who need or desire elective treatment of dermatologic problems during pregnancy often use topical agents. Most benign topical agents are FDA category B drugs. The accompanying table on topical drugs with minimal risk shows only those category B drugs not contraindicated by the manufacturer for use during pregnancy. Some topical agents, such as erythromycin and benzoyl peroxide, are designated as category C drugs. Use of small amounts of topical steroids during pregnancy is not believed to be associated with significant risk to the fetus.
Life-threatening dermatologic conditions may require the use of systemic antibiotics during pregnancy. The accompanying table on drugs that may be used when medically necessary (p. 546) lists the FDA and TERIS risk categories of these drugs. Most of these drugs are either category B or C, but much of the data regarding risk have been compiled from less than optimal sources. Ibuprofen, ketoprofen and naproxen are category B drugs that should not be used during the latter part of pregnancy. The use of lidocaine with or without epinephrine for routine dermatologic excisions during pregnancy has not been contraindicated. TERIS ratings indicate that oral corticosteroids are unlikely to cause harm, but the data sources are listed as fair to poor.
Few topical or systemic dermatologic drugs are contraindicated during lactation, although some, including topical antifungal agents, have manufacturer's prohibitions. Drugs with no specific contraindications during lactation are also listed. The American Academy of Pediatrics regards prednisolone and prednisone as usually compatible with lactation.
The author presents a list of dermatologic drugs that may be used during pregnancy and lactation. Potential problems can be minimized by increasing awareness of potential fetal risks and obtaining informed consent from patients. Safety must always be weighed against the need to use the specific drug for a documented condition.