Why is it so hard for pregnant women to find good medical advice?
And yet it is in widespread use. In fact, there are potentially hundreds of drugs being taken by pregnant women that little is known about, says Xiaobin Wang, MD, a pediatrician and director of the Center on the Early Life Origins of Disease at the Johns Hopkins Bloomberg School of Public Health. Huh. There are “too many questions” about these drugs and pregnancy, she says, “and too little data to give definitive answers.”
Partly that’s because pregnant women have long been excluded from clinical trials of drugs that may be beneficial. A 2014 review published in Frontiers in Pediatrics found that from the late 1960s to August 2013, only 1.3 percent of clinical trials focused on how drugs move through the body, This includes pregnant participants. The result of this lack of research has been that people who are pregnant should take such drugs anyway, but with no data to say which dosage is safest and most likely to work – a significant shortcoming. , given that pregnancy causes the body to metabolize drugs differently. . “If you don’t do studies in pregnant and lactating women, instead of protecting pregnant women, you’re going to be providing care without any evidence to guide it,” says Katherine Y. Spong, chief of the department of maternal fetal medicine at the University of Texas Southwestern Medical Center. This can include relying on older drugs with long track records, for which the potential risks appear small – such as acetaminophen – when newer ones may be safer and more effective.
“It’s not that we can’t do that,” Spong says. After all, there are clear protocols for including pregnant participants in medical research. For example, if researchers conduct early reproductive toxicology studies in animals, they may be enrolled in clinical trials of new treatments. But for drugs already in use, the funding needed to study them has been difficult to find (although there is legislation that provides funding and incentives for research on children’s drugs). Simply put, those who are pregnant are left without the same evidence-based treatment options available to other adults.
In the absence of better guidance or alternatives, Christensen and colleagues say that women who need acetaminophen should continue taking it with a doctor’s consultation. (In fact, asking a doctor before taking any medication is already standard advice for pregnant women.) Their goal to publicize their findings is to reach pregnant people, which, they say, surveys have shown. That they may be taking the medicine without being aware of it. Potential risks, or those who are using it in an ongoing effort to manage conditions – such as back pain or migraines – for which it is not very effective. In those cases, popping some Tylenol and letting it harden over an extended period of time may come with a greater risk than before, while not necessarily solving the user’s pain. The authors of the statement also hope to promote more research and persuade regulatory agencies, including the FDA, to review the existing literature.
But the question of how to best respond to risks during pregnancy is — frustratingly and frighteningly — complicated and hard to quantify. “It may be that we never really have an answer,” says Sarah Richardson, a professor of history of science at Harvard. “If we can never know, should we act on that?” In this case, she argues that no: “If this is the time to issue precautionary action, we may find ourselves in a scenario where everything and anything is dangerous for pregnant women.” Christensen disagrees: “I would rather be informed of the potential risk than live in my lack of knowledge.” But, he adds, “it’s not a black-and-white discussion.”
Kim Tingley is a contributing writer for the magazine.
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