Common Drugs for Breastfeeding

Recruiting at 13 trial locations

Overseen By Emily Forgey

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: DOI per SOC

Disqualifiers: Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the amount of certain prescription drugs taken by breastfeeding women that transfers into their breastmilk and how much of that milk their infants consume. The study focuses on medications such as antibiotics, antidepressants, and other common prescriptions. As an observational study with no interventions, participants will maintain their current treatments. This trial suits breastfeeding mothers taking at least one of the studied medications and whose infants consume their milk. As an unphased study, it offers participants the chance to contribute to important research that can enhance understanding of medication safety during breastfeeding.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since the study involves women who are already taking certain drugs, it seems likely that you will continue your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many drugs in this trial are generally safe to use while breastfeeding. For example, azithromycin appears in low levels in breastmilk and is used in infants at higher doses without expected side effects. Ciprofloxacin is also considered safe, as it appears in breastmilk in low amounts unlikely to harm the baby.

Citalopram and escitalopram, both antidepressants, are commonly used during breastfeeding with minimal risks reported. Sertraline is especially noted for its low levels in breastmilk and is often recommended for breastfeeding mothers who need antidepressants.

Antibiotics like clindamycin and doxycycline can be used carefully, but clindamycin might affect the baby's gut health. Ondansetron, used for nausea, has limited information available, but no negative effects have been reported during breastfeeding.

Labetalol and nifedipine, used for high blood pressure, show low levels in breastmilk and are considered safe. Metformin, a diabetes medication, is found in low amounts in breastmilk, posing little risk to babies.

However, some drugs need careful consideration. Oxycodone, a pain reliever, can cause drowsiness in babies and should be avoided if possible. Similarly, hydroxyurea and valganciclovir are not recommended during breastfeeding due to potential risks to the baby.

Consulting a healthcare provider about any concerns is important to ensure the best choices for both mother and child. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover important information about how commonly used medications behave in lactating women and their breastfed infants. This study seeks to determine drug concentrations in breastmilk and estimate the relative dose infants receive. By understanding the pharmacokinetics and safety profiles of these drugs, healthcare providers can make more informed decisions about medication use in breastfeeding mothers, potentially leading to safer and more effective treatment options for both mothers and their infants.

What evidence suggests that this trial's treatments could be effective?

This trial will observe the pharmacokinetics and safety profiles of various drugs commonly administered to lactating women. Research has shown that many drugs in this study, such as metformin, sertraline, and labetalol, are generally safe to use while breastfeeding. Metformin and sertraline, for instance, appear in breastmilk in small amounts and usually don't harm infants. Labetalol also appears in low levels in breastmilk, posing little risk to babies. However, drugs like oxycodone and ciprofloxacin can pass into breastmilk in larger amounts and might affect infants, so caution is necessary. Each drug is different, and the amount that enters breastmilk can impact its safety. Research on other drugs, such as azithromycin and doxycycline, shows they can also transfer into milk, but their effects on infants are still under study. ^{1 3 4 6 7}

Who Is on the Research Team?

Kanecia Zimmerman, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.

Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Collection of breastmilk and blood samples from mothers and blood samples from infants to measure drug concentrations

Up to 180 days

Multiple visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after sample collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anakinra
• Azithromycin
• Ciprofloxacin
• Citalopram
• Clindamycin
• Doxycycline
• Escitalopram
• Fluvoxamine
• Furosemide
• Gabapentin
• Hydrochlorothiazide
• Hydroxyurea
• Labetalol
• Levofloxacin
• Metformin
• Nifedipine
• Ondansetron
• Oxycodone
• Remdesivir
• Rosuvastatin
• Sertraline
• Sumatriptan
• Topiramate
• Trazodone
• Valganciclovir
• Venlafaxine
• Verapamil

How Is the Trial Designed?

Group I: sertraline Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group II: oxycodone Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group III: ondansetron Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group IV: nifedipine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group V: metformin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group VI: labetalol Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group VII: escitalopram Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group VIII: clindamycin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group IX: azithromycin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group X: Verapamil Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XI: Venlafaxine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XII: Valganciclovir Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XIII: Trazodone Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XIV: Tranexamic acid (TXA) Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XV: Topiramate Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XVI: Tocilizumab Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XVII: Sumatriptan Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XVIII: Rosuvastatin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XIX: Remdesivir Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XX: Paroxetine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXI: Methylphenidate Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXII: Levofloxacin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXIII: Levetiracetam Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXIV: Hydroxyurea Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXV: Hydrocodone Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXVI: Hydrochlorothiazide Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXVII: Gabapentin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXVIII: Furosemide Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXIX: Fluvoxamine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXX: Duloxetine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXI: Doxycycline Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXII: Cyclobenzaprine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXIII: Citalopram Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXIV: Ciprofloxacin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXV: Bupropion Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXVI: Buprenorphine Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXVII: Anakinra Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Group XXXVIII: Amoxicillin Experimental Treatment 1 Intervention

No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women. The primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.

Anakinra is already approved in European Union, United States for the following indications:

Approved in European Union as Kineret for:

• Rheumatoid arthritis
• Cryopyrin-associated periodic syndromes
• Deficiency of interleukin-1 receptor antagonist
• COVID-19

Approved in United States as Kineret for:

• Rheumatoid arthritis
• Deficiency of interleukin-1 receptor antagonist
• Neonatal-onset multisystem inflammatory disease (NOMID)
• COVID-19

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK501871/

Anakinra - Drugs and Lactation Database (LactMed®) - NCBI Effects in Breastfed Infants. A woman was receiving anakinra 100 mg daily for adult-onset Still's disease during pregnancy and lactation. Her ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03511118

Pharmacokinetics and Safety of Commonly Used Drugs in ... Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the ...

3. academic.oup.com academic.oup.com/ehjcr/article/8157045

Anakinra during pregnancy and lactation for corticosteroid ... Due to limited data on the safety of anakinra there is only low-grade evidence supporting its use during pregnancy and breastfeeding. The European League ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/103950s5189lbl.pdf

anakinra - accessdata.fda.gov Most patients received a starting dose of 1 to 2 mg/kg/day and thereafter doses were individually adjusted to reach a stable efficacious dose.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4267708/

Lactation and the Use of Biologic Immunosuppressive ... There is one case report of a woman breastfeeding her infant while using anakinra without any apparent adverse outcomes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525008292?dgcid=rss_sd_all

Use of anakinra during pregnancy and breastfeeding in ... Our small case series suggests that the use of anakinra during pregnancy and lactation may be considered safe in pregnant women with recurrent pericarditis in ...

7. ema.europa.eu ema.europa.eu/en/documents/product-information/kineret-epar-product-information_en.pdf

kineret-epar-product-information_en.pdf Clinical efficacy and safety in RA The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1 790 RA patients ≥ 18 years ...