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By Allen Cone, UPI
A National Institutes of Health task force recommended additional research on the affects of drugs used by pregnant women and nursing moms.
The Task Force on Research Specific to Pregnant Women and Lactating Women submitted its final recommendations to U.S. Health and Human Services Secretary Alex M. Azar II, the NIH announced Monday.
The task force was established by Congress' 21st Century Cures Act and led by NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Reviewing current research and focusing on specific drugs, formulations and other pharmacological factors, the task force made 15 recommendations for pregnant women and nursing mothers and their children. They also conducted public hearings.
"There is limited scientific knowledge about the effectiveness and optimal dosing of drugs commonly prescribed for pregnant and lactating women," Dr. Diana W. Bianchi, the NICHD director, said in the press release. "This needs to change. The theme that resonates clearly throughout the task force recommendations is that we need to emphasize the importance of protecting these populations through research instead of from research."
The task force wants research studies that comprise pregnant woman and nursing women, including removing regulatory barriers. Also sought are more clinicians and researchers with expertise in obstetric and lactation pharmacology and therapeutics.
The task force looked at dosing, finding what is approved for the general population may not apply to pregnant or nursing women. There may be safety considerations for the developing fetus or newborn, and pregnancy can change how drugs are metabolized and cleared, the task force said.
Also stopping medications to treat a medical condition during or after pregnancy may have severe consequences.
In addition, they urged more research to develop new drugs to treat pregnancy-related conditions.
The task force included officials from government agencies as well as representatives from medical societies, nonprofit organizations and companies that focus on the health of pregnant women, nursing mothers or children.
"On a daily basis, pregnant women and lactating women and their clinicians are forced to make decisions about whether to therapeutically treat pre-existing or emerging medical conditions such as epilepsy, chronic hypertension, asthma, mastiti and cholestasis without adequate scientific knowledge of the safety and efficacy of these treatments in this population," the authors wrote in the 382-page report. "Decisions not to treat or inadequate treatment options pose significant risks for the health and survival of pregnant women and their offspring. Consequently, patients and clinicians cannot make appropriate and informed risk-benefit decisions."
In 2016, researchers published an analysis of 198 studies involving 121 different medications during pregnancy, included antiretrovirals, antiepileptic drugs, antibiotics, antimalarial drugs and cardiovascular drugs. The studies took place in 2015 and 2016.
More than 90 percent of women took drugs, including prescription and over-the-counter medications, at some point during their pregnancy, the authors noted.
"This systematic review of pregnancy-associated pharmacokinetics changes identifies a significant gap between the accumulating knowledge of PK changes in pregnant women and our understanding of their clinical impact for both mother and fetus," the authors wrote in the study published in PLOS Medicine. "It is essential for clinicians to be aware of these unique pregnancy-related changes in PK, and to critically examine their clinical implications."
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