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UCSD receives $6.1M to study effects of medication on infants, milk

Posted at 10:58 AM, Sep 10, 2021

SAN DIEGO (CNS) - Researchers at UC San Diego School of Medicine have received a $6.1 million grant to launch a new Center of Excellence in Therapeutics to study the effects of medications on human milk and infant health.

According to the researchers, more than 70% of breastfeeding women take some form of medication, but 90% of those medications are not appropriately labeled for pregnant or lactating women. This means the drugs are taken "off-label" or without Food and Drug Administration approval, largely because they have never been tested in this population. Even less is known about whether these drugs enter the mother's breast milk or are safe for the baby to consume that way.

Initial studies at the UCSD center will focus on antibiotics. Antibiotics are some of the most frequently used medications by breastfeeding women, and are necessary treatments for many infections. However, their effects on child development via breast milk exposure remain largely unknown.

"UC San Diego's CET will bring together basic and data scientists, pharmacologists and clinical researchers to study the most commonly prescribed antibiotics and their impact on breast milk and pediatric health," said Dr. Adriana Tremoulet, professor of pediatrics at UCSD School of Medicine and lead principal investigator for the project.

UCSD joins Vanderbilt University, Indiana University, and Ohio State University to form the new Maternal and Pediatric Precision in Therapeutics Hub funded by the National Institutes of Health. The four institutions will work together to serve as a national resource for knowledge and expertise in maternal and pediatric pharmacology.

"We are particularly excited about the specific focus on breastfeeding and human milk," said Lars Bode, professor of pediatrics and director of the Larsson-Rosenquist Foundation Mother-Milk-Infant Center at UCSD School of Medicine, who will lead the MPRINT Milk Analytics Core.

"Human milk plays such a vital role at the interface of maternal and infant health," Bode said. "Yet, we know so little about the effects of therapeutics in this critical space."

The team will investigate how antibiotics alter the composition of breast milk and impact the infant microbiome, metabolome, and immune response. They will also assess whether the components of breast milk influence the effectiveness of therapeutics given to the breastfed babies.

"Antibiotic resistance is a huge emerging problem," said Bode. "We also realize how important the microbiome is for short- and long-term health, so you can imagine if you go in with antibiotics that disrupt the baby's microbiome, it may do more harm than good."

While it is important to understand the potential consequences of antibiotic use, Bode notes that it is equally important to determine if and when taking these medications is actually safe.

"My biggest concern is that when a woman is prescribed medications, often the default recommendation is to stop breastfeeding, out of fear of the unknown," he said. "We have learned so much in recent years about the many benefits of breastfeeding for both the infant and the mother.

"Infants who receive human milk have fewer infections and are also less likely to become obese or suffer from allergies later in life," Bode said. "Women who breastfeed are less likely to develop breast or ovarian cancer. So ideally, we don't want physicians to have to make that recommendation to stop breastfeeding simply because of a gap in knowledge."

Dr. Christina Chambers, professor at UCSD School of Medicine and Herbert Wertheim School of Public Health and Human Longevity Science, will lead clinical studies at the CET and co-direct the Administrative Core with Tremoulet.

In addition to these studies of mothers and infants, the center will also conduct computational data science studies and basic research in mice.