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Study of drugs quantification in breast milk

We are looking for participants for a study

Welcome to the web page of our project entitled Drugs Quantification in Breast Milk, a project of the Faculty of Pharmacy of the Université de Montréal, the department of obstetrics and gynecology of CHU Sainte-Justine and the team of pharmacists at Centre IMAGe.

What is the purpose of this study?

The primary objective of this study is to determine the feasibility of dosing several drugs in breast milk using specific analytical techniques. This study consists of collecting breast milk samples from breastfeeding women who are treated with predetermined medications. The chosen drugs are those for which there is a lack of information on their excretion into breast milk. This study will provide a better understanding of the excretion of these drugs into breast milk, which will help health professionals to improve clinical recommendations for the use of these medications during breastfeeding.

This project has been approved by the Ethics and Research Committee of CHU Sainte-Justine.

How is the study conducted?

The study is conducted in two parts:

  • The first part consists of answering two short phone questionnaires (10 to 20 minutes), each separated by two week intervals, on the evolution of breastfeeding as well as on the health status of the mother and the child.
  • The second part involves collecting six to eight samples of breast milk that have to be sent to the research team at the Faculty of Pharmacy of Université de Montréal. Subsequently, these samples will be analyzed in order to quantify the drug into the milk.

The research team will provide full details on the collection, storage, and delivery of samples.

Since the analytical techniques are developed specifically for this study, several weeks for sample analysis are required; thus, the decision to breastfeed or take the drug cannot be based on the results of the analysis of the milk samples. Treatment decisions and infant monitoring (follow-up) parameters should be determined by the mother and her health professionals based on currently available data on the safety of the drug during breastfeeding, considering all the characteristics specific to each woman and newborn child. Once available, the results of the analysis could be provided to the participant and her health professional.

The researchers in this study do not provide medical follow-up: for any medical question, please contact your doctor.

Who can participate in this study?

Eligible women must be:

  • Breastfeeding, or pregnant (will be breastfeeding soon)
  • At least 18 years old
  • Living in the province of Quebec
  • Able to speak French or English
  • Taking (or planning to take) one of the targeted medications while breastfeeding

Important notice

Drugs included in this study are those for which there is a lack of information on their safety during breastfeeding. In general, your health care professional will prefer to prescribe better-known medicines if you are breastfeeding.

However, in some cases, after discussion with your health care professional, some of these medications may still be used despite the lack of information.

In this case, the decision to take the drug while breastfeeding must be made with your healthcare professional taking into account all the clinical factors and with appropriate follow-ups.

In any case, consult your health care professional if you have any question about any of these medications while breastfeeding.

This study does not constitute an approval to use any of the drugs listed while breastfeeding.

The following drugs are included in our study:

  • Atomoxetine (Strattera® and other trade names)
  • Aripiprazole (Abilify® and other trade names)
  • Bisoprolol (Monocor® and other trade names)
  • Clomiphene (formerly Clomid®, Serophene®)
  • Dicyclomine (Protylol® and other trade names)
  • Lacosamide (Vimpat® and other trade names)
  • Letrozole (Femara® and other trade names)
  • Levomilnacipran (Fetzima®)
  • Melatonin (several trade names)
  • Methotrexate (several trade names)
  • Mexiletine (Mexitil® and other trade names)
  • Mycophenolate mofetil or mycophenolic acid (Cellcept®, Myfortic®, and other trade names)
  • Ondansetron (Zofran® and other trade names)
  • Solifenacin (Vesicare® and other trade names)
  • Tamsulosin (Flomax® and other trade names)
  • Vilazodone (Viibryd®)
  • Vortioxetine (Trintellix®)

Would you like to know more about our study?

Contact us by phone or email. A research assistant will contact you as soon as possible to explain the project and to answer any question.

You are a health professional and would like to know more about our project? Feel free to contact one of the members of the research team.

To join us

Leave us a message on our voicemail or by email; the research assistant in charge of the project, Anaëlle Monfort, will contact you as soon as possible to provide all details needed.

The research team

Anaëlle Monfort, BSPB, étudiante à la maîtrise en sciences pharmaceutiques, Faculté de pharmacie, Université de Montréal

Ema Ferreira, B.Pharm., M.Sc., D.Pharm., FCSPH, FOPQ, pharmacienne, CHU Sainte-Justine, professeure titulaire de clinique et vice-doyenne aux études de premier cycle, Faculté de pharmacie, Université de Montréal

Grégoire Leclair, Ph.D., professeur agrégé, Faculté de pharmacie, Université de Montréal

Isabelle Boucoiran, MD, gynécologue-obstétricienne, CHU Sainte-Justine, professeure adjointe de clinique, Faculté de médecine, Université de Montréal

Brigitte Martin, B.Pharm., M.Sc., pharmacienne, CHU Sainte-Justine, clinicienne associée, Faculté de pharmacie, Université de Montréal

About this page
Updated on 4/9/2019
Created on 4/7/2019
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