Most drugs and vaccines are safe for women to take while breastfeeding, the American Academy of Pediatrics reemphasized, noting proposed changes to drug labeling that should make checking easier.
Caution is needed for the small proportion of drugs that are concentrated in human milk, have a long half-life, have known toxicity to mother or child, or expose the infant to relatively high doses or detectable serum concentrations, according to a clinical guidance report in the September issue of Pediatrics.
Clinicians should look up safety of specific medications on the National Library of Medicine's peer-reviewed LactMed database online, Hari Cheryl Sachs, MD, a pediatrician at the FDA in Rockville, Md., and colleagues wrote.
Her agency proposed a change in drug labeling in 2008 and is now working on the final rule.
The "Nursing Mothers" section that often simply advised caution or discontinuation of breastfeeding or the drug, depending on importance to the mother, would be replaced with a section called "Lactation." This will summarize what is known about drug secretion in milk and potential effects on the infant, what can be done to minimize infant exposure, and how to monitor for adverse effects.
A cautious approach emphasizing fear of adverse effects for their baby has led many mothers to unnecessarily stop breastfeeding or avoid taking essential medications, Sachs's group pointed out.
"The benefits of breastfeeding outweigh the risk of exposure to most therapeutic agents via human milk," they wrote in the report.
Even when clinicians use these resources, the paucity of data means clinical judgement will still be required, cautioned Ruth A. Lawrence, MD, a pediatrician and clinical toxicologist at the University of Rochester Medical Center in Rochester, N.Y., who was director of one of the first poison control centers in the country.
The report agreed, citing the greater vulnerability of some infants, such a preemies or neonates, due to immature organ function or underlying medical conditions.
"Consultation with a specialist may be indicated, particularly when the use of radiopharmaceuticals, oncologic drugs, or other therapies not addressed by LactMed is contemplated," it added.
Maternal immunization isn't a problem for breastfeeding infants, even for live vaccines, such as rotavirus, according to the guidance document.
The exceptions were immunization against human papillomavirus (HPV) for mothers of infants vulnerable to respiratory illnesses, such as preterm infants or those with congenital heart disease or chronic respiratory problems, and vaccination against smallpox or yellow fever, due to high risk of vaccinia for the child.
The report also addressed common concerns about antidepressants, anxiolytics, and antipsychotics, many of which show up in low concentrations in breast milk.
Clinically significant levels of drug have been reported in breast milk for bupropion (Wellbutrin), diazepam (Valium), fluoxetine (Prozac), citalopram (Celexa), lithium (Eskalith), lamotrigine (Lamictal), and venlafaxine (Effexor).
A long half-life also means relatively high infant plasma concentrations with a number of serotonin reuptake inhibitors, antipsychotics, anxiolytics, and mood stabilizers.
Again, the report recommended counseling women who want to breastfeed while taking these medications on the risk-benefit balance and the unknown long-term impact for the child.
It also addressed the "numerous questions" raised about the use of methadone for treating opioid dependence in lactating women since the last report in 2003. The report pointed out that although the product label cites risk of lethargy, respiratory difficulty, and poor weight gain in exposed infants, methadone levels are low in breast milk and infant plasma.
Guidelines from the Academy of Breastfeeding Medicine support breastfeeding for women on methadone as part of a methadone-maintenance program.
Codeine and hydrocodone should be used cautiously for nursing mothers and with close monitoring due to poor clearance in neonates and adverse events seen in ultra-rapid metabolizers; other narcotic painkillers are preferred.
. The statement indicated that any conflicts of interest have been resolved through a process approved by the AAP board of directors. All AAP clinical reports expire 5 years after publication unless reafï¬rmed, revised, or retired at or before that time.
By Crystal Phend, Senior Staff Writer, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
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