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OTC meds & pregnancy: Citing potential risk, group of experts urges transparency, studies

TURIN, ITALY - JUNE 23: A pregnant woman during the last class of the pre-birth course in the Maternity House "Prima Luce". Here, qualified midwives teach women the importance of breastfeeding, explaining several advantages and techniques, in order to take care of their future child and their own health. They help them better prepare for the postnatal period{>}{>} on June 23, 2022 in Turin, Italy. Amid baby formula shortages in the United states, Europe has the world's lowest number of breastfeeding mothers. (Photo by Diana Bagnoli/Getty Images)
TURIN, ITALY - JUNE 23: A pregnant woman during the last class of the pre-birth course in the Maternity House "Prima Luce". Here, qualified midwives teach women the importance of breastfeeding, explaining several advantages and techniques, in order to take care of their future child and their own health. They help them better prepare for the postnatal period
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Moms-to-be try to make all the right choices to protect the health of their baby. Now, some experts are pushing for new research into a common over-the-counter medication that's long been regarded as safe to take while pregnant.

Spotlight on America examined research into acetaminophen, the most popular brand of which is Tylenol, and whether it could pose a risk to a child's development. As more studies are done, a group of leading physicians and scientists are calling for better communication with expecting mothers.

Karleen DeGroodt is an ICU nurse, dedicated to caring for the sickest patients in her California hospital. That includes working grueling 12-hour shifts, even when she was pregnant with her son Devyn in 2008.

She remembers being exhausted from moving patients around the ICU and suffering from aches and pains. To cope, she took Tylenol, a brand of acetaminophen, sometimes up to three times a week.

Acetaminophen is found in more than 600 medications used to relieve mild to moderate pain and reduce fever.

She told us Tylenol was part of a "goody bag" she received from her OB/GYN, and that she was never cautioned about any potential risk to the baby.

By some estimates, 65% of pregnant women take the drug, which has widely been regarded as safe.

Karleen recalls being told, "this is the safe medication. This is the only medication that a pregnant woman could take, and that's how it was explained to me."

But now, some scientific research is revealing potential risks, with more than two dozen studies raising questions about a possible connection between prolonged prenatal use of acetaminophen and autism and ADHD.

Karleen believes her regular use of the drug may have contributed to her son's diagnosis. Now 14, Devyn is on the autism spectrum, is non-verbal and communicates using an iPad.

We have gone through multiple therapists and special education schooling," Karleen told Spotlight on America. "It's something that truly infects every cell of the family dynamic."

As millions of families face autism diagnoses, some leading scientists are calling for more studies looking at the prenatal use of acetaminophen, and whether there is a potential connection.

Dr. Roberta Ness told us she's on a mission to bring this issue into mainstream conversation.

Dr. Ness is the former Dean of the University of Texas School of Public Health and a longtime adviser to the National Institutes of Health and the Centers for Disease Control and Prevention. She was a key witness in the trial that found Johnson & Johnson liable for failing to warn customers of the potential risk of ovarian cancer associated with baby powder.

Now, she's disturbed by the growing body of research surrounding acetaminophen.

There's an enormity of science," said Dr. Ness. "There have been 29 studies from around the world. 26 of those 29 studies have shown that acetaminophen is associated either with autism or ADHD, attention deficit disorder, amongst the offspring of those pregnant women."

Spotlight on America examined some of the studies.

  • A 2019 study funded by the NIH suggested acetaminophen exposure in pregnancy is linked to a higher risk of ADHD and autism.
  • Research done in 2021 found children exposed to prenatal acetaminophen were 19% more likely to have borderline or clinical autism spectrum conditions and 21% more likely to have ADHD symptoms compared to non-exposed children.

"It frankly should appall women across the country that they have never ever heard about this," Dr. Ness told us, adding that 16 of the 19 studies showed that the longer the duration of the drug use, the more "profound" the effect, signaling that if women need to take it, they should take it for the shortest amount of time in the lowest amount possible.

For Dr. Ness, it's about transparency.

"American women are always the last to know," she said. "I do not understand, as a women's health expert, researcher, advocate my whole life, I do not understand why women are still treated as some vulnerable little things that we can't somehow assess the information and come to some reasonable conclusion on our own. "

Even though several studies have made a potential finding of a link between prenatal use of the drug and developmental issues, the authors associated with those studies consistently call for further research. That call is being echoed by a large contingent of leading scientists, who believe there's enough evidence to warrant better communication with expecting moms.

91 leading scientists and clinicians joined together in 2021 to issue a consensus statement, expressing concern about the potential developmental risks - stating that women should be made specifically aware of possible autism risks by both product labels and physicians.

One of those 91 scientists is Ann Bauer, a researcher at the Center for Autism Research and Education at the University of Massachusetts Lowell.

We want warning labels," Bauer told Spotlight on America. "I think we have to at least treat it like we do large fish that contain mercury and caffeine and these other things that early on in pregnancy, women are told to try to avoid. It should be among those."

According to the consensus statement: "Although these recommendations might not substantially differ from advice currently given to pregnant women, we believe that APAP-specific risk communication between health professionals and pregnant women is warranted due to the high prevalence of use and a widespread perception of negligible risk." APAP is short for N-acetyl-para-aminophenol, or acetaminophen.

The statement acknowledges that acetaminophen is an important medication to reduce fever in pregnant women, which can pose a serious risk to the fetus. However, it estimates that only between 8% and 33% of women use it for that purpose. Instead, it stated that the majority of uses are elective, for things like headache, muscle pain, back pain and infection.

It's those instances that Ann and her co-authors want acetaminophen to be closely considered, and believe that women should be counseled early in pregnancy about the following:

  • Pregnant women should forego APAP use unless medically indicated.
  • Pregnant women should consult with their physician or pharmacist if they are uncertain whether the use is indicated and before using on a long-term basis.
  • Pregnant women should minimize risk by using the lowest effective APAP dose for the shortest possible time.

The consensus statement also calls on the Food and Drug Administration to update its guidance about the prenatal use of acetaminophen to reflect the latest science. The agency hasn't formally weighed in since 2015, writing seven years ago that the studies that existed then were "too limited" to warrant new recommendations.

Bauer says that has changed.

"The evidence has gotten stronger as time has gone on," she said. "There's enough here that women should be cautioned."

The FDA wouldn't agree to an interview and didn't answer our specific questions.

Instead, the agency told us,

"The FDA is aware of the consensus statement.

"The FDA continues to review the published literature and to monitor the potential impacts of acetaminophen. While a great deal has been written about the impacts of acetaminophen and pregnancy, as noted by a recent response published by the American College of Obstetricians and Gynecologists (ACOG), neurodevelopment disorders are caused by a variety of causes, and it is difficult to associate neurodevelopment disorders with a single cause.

"The response from ACOG can be found here:"

ACOG also refused to speak with us, referring us only to their statement, saying the Bauer consensus statement showed "no clear evidence of a direct link to autism and ADHD." The consensus statement has also been disputed in subsequent articles, cautioning that its content could "promote unwarranted uncertainty, fear and guilt among pregnant women."

Johnson & Johnson, the manufacturer of the world's leading brand of acetaminophen, Tylenol, declined an interview with us. In writing, the company called the consensus statement an "outlier opinion" of a small group and pointed out that some in the medical community have disputed its findings. The company told us, "when scientifically warranted, we have and will pursue changes to our product labels for our over-the-counter medications." You can read the company's full response at the bottom of this article.

While bottles of acetaminophen typically have a label that says "talk to your doctor if pregnant or breastfeeding," Karleen DeGroodt says that's not enough. She's pushing for more awareness at physicians' offices so that women can be empowered to make the best choices about their needs.

"Give them this information so they can figure out with their doctor what’s best for them. That’s what it really comes down to," she said.

Experts we talked to want to make it clear: pregnant women should not have to be in pain. Dr. Ness and others say instead, patients should discuss all symptoms with their doctor and evaluate pain management strategies to ensure women are taking the medication at the lowest dose for the least amount of time possible.

Karleen is part of a growing body of lawsuits that are moving forward, with a team of experts and attorneys that include powerhouse names like Erin Brockovich. A judge recently allowed families to file lawsuits involving Tylenol, autism and ADHD in a multi-district litigation matter. Attorneys estimate that tens of thousands of families may participate.

You can read more about the lawsuits from the plaintiff's perspective here.


Below, you can read the full statement from Johnson & Johnson concerning this issue:

On Claims Related to APAP Use During Pregnancy

“Nothing is more important to us than the health and safety of the people who use our products. We continue to evaluate the latest science and have not seen any evidence that validates a causal link between acetaminophen use during pregnancy and fetal developmental issues.

Every global health regulator and leading medical organization who has weighed in on this issue continues to stand behind the safety of acetaminophen, its use during pregnancy, and the information on the product labels. In fact, the U.S. Food and Drug Administration (FDA) has repeatedly considered the decades of data associated with acetaminophen use during pregnancy and maintains the same labeling requirements.

Our TYLENOL label specifically states: ‘If pregnant or breast-feeding, ask a health professional before use.’ We also make this information available to consumers via our TYLENOL website, call center and other external channels.”

On the Bauer 2021 “Consensus Statement”

“The Bauer article is an outlier opinion of a small group whose position has been rejected by their own medical organizations and every regulatory body to address the issue. To give credence to theories lacking sound science would only serve to harm the millions of women that will be pregnant in the United States this year.”

On Scientific Assessments of APAP

“With more than 30,000 related scientific publications, acetaminophen is one of the most studied medications in history. Based on the available data to date, the information we have analyzed has resulted in the same conclusions reached by leading medical organizations and regulators: there is insufficient evidence supporting a causal link between acetaminophen use during pregnancy and autism and/or attention-deficit/hyperactivity disorder (ADHD).

As a company grounded in science, we take any new information or publications related to our products seriously. We continuously monitor scientific literature, utilize internal and external reporting systems to analyze potential safety signals, and consult with outside experts if necessary. When scientifically warranted, we have and will pursue changes to our product labels for our over-the-counter medications. We will continue to engage in scientific exchange and contribute to the bodies of data related to acetaminophen use during pregnancy in ways that are scientifically meaningful.”

On the APAP Multi-District Litigation (MDL)

“These lawsuits lack legal merit and scientific support. The misinformation campaign launched by the plaintiffs’ bar is irresponsible and could lead to serious health consequences for expecting parents. Pain and fever, for example, are conditions that have scientifically known and recognized potential to harm a human pregnancy if left untreated. Our product labels have directions on how much TYLENOL to take and warnings on how long to treat these conditions before stopping use and consulting with a doctor. Our TYLENOL label also warns pregnant people: ‘If pregnant or breast-feeding, ask a health professional before use.’

The federal judge overseeing the MDL will evaluate expert testimony on the scientific validity of the claims raised to determine whether this litigation will proceed. We are prepared to share our position on the science and are confident the court will find, as the medical and scientific communities have, that these claims are unfounded and should be dismissed.”

On Decades of Regulatory Review

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“Acetaminophen has undergone a level of rigorous scientific, medical and regulatory review that surpasses most medicines in modern history. For more than half a century, FDA has undertaken continuous, periodic, and targeted safety reviews of acetaminophen-containing products, in multiple contexts, and for multiple dosages, indications and patient populations. We have worked with regulators, including FDA, on product labeling since TYLENOL became available and that will not change. FDA has reiterated multiple times that no changes to the labeling requirements for acetaminophen use during pregnancy are warranted at this time.”

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