Is this medication safe when breastfeeding?

WEDNESDAY, April 3, 2019 (HealthDay News) – The safety of using drugs during badfeeding is too little known – and it's time to get some answers, experts say.

This is a critical gap, given that badfeeding is the best source of nutrition for babies – and that mothers are encouraged to do so. But when a woman questions the safety of any medication she takes, doctors usually have little factual advice to offer.

It's according to an article in perspective in the April 4 issue of New England Journal of Medicine highlighting the lack of evidence in this area.

"The purpose of this article is to raise public awareness of the problem," said co-author Catherine Spong. "We must encourage more research."

Spong is vice president of obstetrics and gynecology at the Southwestern Medical Center at the University of Texas at Dallas.

The need for this type of research has been recognized for decades, said Spong and his colleague, Dr. John Byrne. In the 1980s, for example, separate reports from the US Department of Health and Human Services and the American Academy of Pediatrics highlighted this gap.

But it took 20 years for the US Food and Drug Administration to issue guidelines to the industry on how to conduct studies on badfeeding women. And it was only last year that a federal task force released a report containing recommendations on research needs for pregnant and lactating women.

The recommendations indicated that these women should be included in drug research studies, unless there is a "scientific rationale", and regulatory barriers to their participation should be removed.

"There has been a bad idea that you can not do research in this population," Spong said. And this deprived women of valuable information, she added.

According to Christina Chambers, a professor of pediatrics at the University of California San Diego (UCSD), it is not difficult to study badfeeding women.

"It just takes time and money," she said.

Chambers is also President of MotherToBaby, a free service of the Teratology Information Specialist Organization, a non-profit organization. It provides women with information on drug safety during pregnancy and badfeeding.

Ms Chambers said she hoped the new article would draw attention to the lack of research. But she was also optimistic about "hoping that a radical change is coming".

Chambers is a program director of a bad milk standard at UCSD, which provides the very first database of research on bad milk samples. This will allow scientists to study, among other things, the safety of drugs.

A first question is whether a given drug even gets into a woman's bad milk. And if so, how much?

"So what parents really want to know is what does it do?" Chambers said.

Are there any short-term effects on the baby, such as fatigue, irritability or diarrhea? Beyond that, there is the longer-term question of whether drug exposure can affect brain growth or development in any way.

According to Chambers, even if a drug had small effects, one would have to compare the benefits of badfeeding.

For now, Chambers and Spong have recommended the LactMed website as a good resource on medication safety during badfeeding. It is managed by the US government and collects scientific evidence on individual drugs – giving recommendations where possible.

But in November 2018, only 2 percent of the products on the site had recommendations based on "solid data," Spong said.

She emphasized, however, that the intention was not to deter women from badfeeding, but to emphasize the need for research.

"I do not want anyone to move away from this thought:" I should not badfeed, "Spong said.

The rooms accepted. And there are certain badurances in what scientists know at this stage, she noted.

According to LactMed, for example, ibuprofen (Advil), an badgesic, enters bad milk at "extremely low concentrations" – well below the dose that would be administered to the infant. It is therefore considered a "preferred choice" for badfeeding mothers who need pain relief.

Chambers discussed monoclonal antibody therapies used in diseases such as rheumatoid arthritis and Crohn's disease. These are large proteins that must be administered IV because they can not be absorbed orally. Experts believe that they are unlikely to pose a risk to bad-fed babies.

Any woman who is concerned about taking her medication should talk to her doctor, said Spong.

For more information, Chambers added, they can contact a MotherToBaby advisor for free.

More information

Visit the US government's LactMed website for information on medicines and badfeeding.