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Are biologics used by lactating mothers harmful to the infant?

Aug
28

Date: August 28th, 2018

Nursing Mothers can Safely Use IBD Biologics

The question has to whether nursing mothers should use IBD biologics is one that has disturbed both experienced and new mothers. Luckily enough, that issue is no longer a dilemma, thanks to a detailed multicenter research.The study found that there were lower transfer rates of anti-tumor necrosis factor (anti-TNF) agents into breast milk. Furthermore, these biologics could not be associated with any infant infections or inhibitions to the ability of your loved one to achieve crucial development milestones.

How the Study was done

To conduct this study, the researchers assembled samples of breast milk from 72 of 842 mothers receiving biologic therapy from 2013 to 2015. Concentrations of the drug were measured following four timelines, namely: 1, 12, 24 and 48 hours once dosing had been done. The researchers also measured in the points 72, 96, 120, and 168 hours.

In all the samples taken, it was found that the levels were minimal for all the biologics as shown below:

  • natalizumab in one of two treated women (max 0.46 μg/mL)
  • certolizumab in three of 13 treated women (max 0.29 μg/mL)
  • infliximab in 19 of 29 treated women (max 0.74 μg/mL)
  • golimumab no trace (one woman)
  • ustekinumab in four of six treated women (max 1.57 μg/mL)
  • adalimumab in two of 21 treated women (max 0.71 μg/mL)

Biologics safe to use for expectant mothers

Rebecca Matro, MD, of Oregon Health & Science University in Portland, told MedPage Today that “expectant and new mothers always worry about the potential harm of the medications they are taking on their unborn babies… this study is a clear indicator that even though biologics could be spotted in the least amounts, there was no harm to the infants.”

The study authors also noted that lactating mothers have been historically told to keep off anti-TNF and any biological therapies. “Breastfeeding should not worry you since IgA is the predominant immunoglobulin found in breast milk yet the evaluated agents in the study were IgG subclass. Hence, the transfer in breast milk is at its lowest levels.”

Anita Afzali, MD, of Wexner Medical Center, shared her views on the study notes that it made sense molecularly since biologics have a high molecular weight which means their transfer rate must be minimal. “Then again the fact that breast milk is predominated by IgA means the possibility of IgGmonoclonal antibodies moving into the breast milk is at its lowest.”

Furthermore, the researchers established that there was no harm to the ability of the infant to hit crucial developmental milestones. This assessment on development was conducted on the basis of Ages and Stages Questionnaire 3.

The findings of this study can be associated with another research, which concluded that biologics are not the blame for adverse pregnancy outcomes.

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