Most Medications, Vaccines Safe for Nursing Mothers, Infants

Jenni Laidman

August 26, 2013

Although most medications and immunizations are safe for nursing mothers and infants, physicians should consult the National Institutes of Health online database, LactMed, when considering medications for nursing mothers, according to an American Academy of Pediatrics (AAP) report published online August 26 in Pediatrics.

Physicians consider the risks and the benefits of breast-feeding, rather than following the common practice of advising mothers to discontinue breast-feeding or stop taking essential medications, according to Hari Cheryl Sachs, MD, team leader on the pediatric and maternal health staff in the US Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, and colleagues from the AAP Committee on Drugs.

"The benefits of breastfeeding outweigh the risk of exposure to most therapeutic agents via human milk," the authors write. "Although most drugs and therapeutic agents do not pose a risk to the mother or nursing infant, careful consideration of the individual risk/benefit ratio is necessary for certain agents, particularly those that are concentrated in human milk or result in exposures in the infant that may be clinically significant on the basis of relative infant dose or detectable serum concentrations."

Physicians should consider such factors as the mother's need for the drug, the drug's potential effect on milk production, how much drug is excreted into milk, the extent of infant oral absorption of the drug, the drug's potential adverse effects to the infant, and the infant's age and health.

To assist in that evaluation, the authors point to LactMed as a generally comprehensive database on drugs and herbals. The database includes information such as the levels of individual drugs found in human milk and infant serum, possible adverse effects on the infant and/or on lactation, and alternate drug recommendations.

The authors of the AAP report cover several types of drugs in detail, including:

  • antidepressants, anxiolytics, and antipsychotics, some of which appear in breast milk at clinically significant levels;

  • drugs for smoking cessation and substance-abuse prevention, such as methadone and buprenorphine, which may produce lethargy, respiratory difficulty, and poor weight gain in the nursing infant and have unknown long-term effects;

  • pain medications, such as codeine and hydrocodone, which can reach high levels in breast milk and have been associated with unexplained apnea, bradycardia, cyanosis, and sedation;

  • galactagogues such as dopamine antagonists, herbal treatments, and hormonal manipulation, about which there are very little data about efficacy or safety;

  • common herbal products, which have little research behind them and are produced without FDA oversight;

  • agents used in diagnostic imaging, which require interruption or cessation of breastfeeding in most instances; and

  • maternal immunization, which is generally safe, even for live virus inoculations, such as rotavirus.

For example, in the area of psychoactive drugs such as antidepressants and antipsychotics, the data often provide little insight into the long-term effects of these drugs in nursing mothers and infants. Pharmacokinetic studies include few lactating women and only short-term observational study of their infants, the authors note.

Many antianxiety drugs, antidepressants, and mood stabilizers appear in low concentrations in breast milk, with estimated relative infant doses of less than 2% of the weight-adjusted maternal dose and/or milk–plasma ratios of less than 1. Still, clinically significant levels have been reported for several of these drugs, and there are no data on up to one third of psychoactive therapies. The long half-life of some of these compounds and their metabolites, combined with the immaturity of infant hepatic and renal function, may lead to measurable levels of these drugs in plasma and neural tissue. Infant plasma concentrations of more than 10% of therapeutic maternal plasma concentrations have been reported for several selective serotonin reuptake inhibitors, antipsychotics, and mood stabilizers.

Up to 43% of lactating mothers in a 2004 survey used herbal products, but reliable safety information is available for few of these products, and herbals are not subject to the same manufacturing standards and efficacy and safety testing as drugs. Physicians should inquire about a patient's use of herbal substances and nutritional substances. Limited information on herbals and other supplements is available through LactMed.

Pediatrics. Published online August 26, 2013. Full text


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