3 ms·

It sounds unethical to conduct human trials on babies when the mother could simply stop breastfeeding while taking the medication. I wonder if doctors recommend

• haldujai 3y ago
  It is entirely unethical to conduct lactation safety trials on children. It would also be a violation of HHS regulations for pediatric research which clearly state the research must be of minimal risk, not unknown, or present direct benefit to the children which this does not. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/common-rule-subpart-d/index.html#46.404 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/... > ... simply stop breastfeeding while taking the medication. I wonder if doctors recommend that for this or other drugs? Yes, all the time. It was part of the study protocol too. > I'd hope they inform the mother at the very least. It's in both the patient and physician handouts to discuss the risks/benefits and alternatives. Formula is available as are breast milk donations in certain regions. This is neither the first nor last medication that may be excreted in breastmilk we have to deal with in medicine and there are systems and processes in place to address these situations.
• touisteur 3y ago
  Stopping breastfeeding can also deepen depression and increase stress (talking from experience here) so it's really a difficult choice here, depending on the level of danger the mother is to herself. Hopefully some data is compiled in the next years on the actual safety for infants.