Study spotlight: “Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants”


The large-scale study, “Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants”, is being funded by the National Institutes of Health (NIH) in the United States.

Dr. Chan, Site Principle Investigator, says that BCWH was contacted as a potential site for the study being led by the Pediatric Trials Network (PTN), and secured its position as one of four Canadian sites due to its adjacency to BC Children’s Hospital (BCCH), its impressive breastfeeding rate (72.4%), and the volume of pregnant women with medical disorders on medications who could be potentially eligible to participate.

“Often when women are pregnant and they have to be on medications for their medical conditions there’s this conflict [of] whether they should take it or not,” says Dr. Chan. “What [we’re] looking at specifically is more the breastfeeding piece, so that women can be better counselled with respect to those medications that they take for breastfeeding.”

When new medications are released to the market they are not tested in pregnant or breastfeeding women, despite the many medical conditions which require their use throughout pregnancy.  Currently safety information for these drugs’ use during pregnancy and breastfeeding is only obtained through observation of use across large cohorts.

This study will help to bridge this knowledge gap by looking at how much a drug is transferred from mother to child during breastfeeding to help assess the safety of a medication.  The team will begin focusing on ten drugs commonly used within the organization, including antihypertensives, antibiotics, commonly used antidepressants, diabetic medications, and drugs that are used to stop bleeding, and will continue to expand the list of drugs, so long as funding exists.

“To successfully recruit and participate in this study really requires cooperation across the whole organization,” Dr. Chan says. “Participation in this study will move us closer to developing a teratogen information service in BC, where women can call for drug safety information during pregnancy and breastfeeding.”

This study will be unique because it will require collaboration across BCWH and BCCH between obstetric medicine, pharmacists, pediatricians and NICU physicians, as well as the on-site lab and pathology department.

Recruitment is expected to begin within the next two or three months.

Read more about Dr. Chan here.

Read more about the study here.