International Committee Urges Caution in Tylenol Use During Pregnancy
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Pregnant women should avoid taking acetaminophen (often sold under the brand name Tylenol) unless it is medically necessary, according to new consensus statement from a group of experts from the United States, the United Kingdom, Scotland, Israel, Europe, Canada, Brazil, and Australia.
Although the paper does not call for a ban of the drug during pregnancy, the authors urge both healthcare providers and patients to view and use acetaminophen with more caution.
“This statement is an important reminder to both providers and patients to use Tylenol and acetaminophen appropriately, and the recommendations are in line with what already is or should be current practice,” says Donna Neale, MD, assistant professor gynecology at Johns Hopkins Medicine in Baltimore and director of the Center for Maternal and Fetal Medicine at Howard County General Hospital in Columbia, Maryland.
“The authors clearly say, if you need to use Tylenol or acetaminophen, then you should use it. Use it at the lowest dose possible, use it for the least amount of time, or shorter frequency, and that’s exactly what we tell our patients,” says Dr. Neale.
Even people who are not pregnant should be mindful of the potential risks of acetaminophen she adds. “We know that acetaminophen causes hepatic damage or hepatic toxicity (damage to the liver) in the nonpregnant state, and so we tell all our patients to take this drug only when necessary,” she says.
Paper Highlights Potential Risks of Acetaminophen Use During Pregnancy
According to the authors of the statement, published September 23 in the journal Nature Reviews Endocrinology, research has emerged over the last several years that suggests it is possible for the drug to alter fetal development, which in some cases could result in neurological, urological, and reproductive disorders in the infant.
The group based their recommendations on a review of 29 studies that included the use of acetaminophen, 26 of which found evidence of birth defects.
“In addition to reaffirming that Tylenol and any drugs that contain acetaminophen should only be used when medically necessary, the authors suggest that there may be evidence why there should be caution. These drugs may cause potential abnormal development in children who have been exposed prenatally,” says Neale.
Because of that potential risk, the authors recommend that pregnant women should be counseled before or early in pregnancy with the following guidance:
- Avoid taking acetaminophen unless medically indicated.
- If you are uncertain whether use is indicated or you are considering taking acetaminophen long-term, consult with your doctor or pharmacist first.
- Take the lowest effective dose for the shortest possible time.
This guidance is important, says Neale. “There can be some overuse with medications, including Tylenol, for lots of smaller aches and pains. People may think there’s no downside to acetaminophen because it’s sold over the counter, and it’s not an addictive pain medicine such as an opioid,” she says.
Few Options for Pain Relief During Pregnancy
Part of the issue is that there are few options for pain relief during pregnancy, according to the paper.
“Recommending acetaminophen has been helpful in the past to give pregnant women a pain-relief option, as the use of nonsteroidal anti-inflammatories, like ibuprofen, can result in fetal harm late in pregnancy,” says Kristina Adams Waldorf, MD, an ob-gyn at UW Medicine in Seattle.
On October 15, 2020, the U.S. Food and Drug Administration (FDA) advised pregnant women not to take NSAIDS such as aspirin, ibuprofen, and naproxen after 20 weeks because it may result in low amniotic fluid.
Acetaminophen Use May Be Medically Necessary During Pregnancy
During pregnancy, using acetaminophen may be medically necessary and an important tool to treat high fever, according to the authors.
Neale agrees, saying, “The risks and benefits are always weighed in prescribing any medication, and there are times when the benefits of Tylenol will clearly outweigh any risk,” says Neale.
“For example, if a pregnant woman has a fever, that is not good. Depending on at what point in the pregnancy an elevated body temperature happens, it can lead to congenital abnormalities, particularly neural tube defects or spina bifida,” she says.
If it’s a choice between letting the patient have a fever or using acetaminophen to bring the fever down, acetaminophen will be used for fever reduction, says Neale. “But in many cases, we might just need to use two doses to achieve that, and then we wouldn’t use it anymore,” she says.
If you are currently pregnant and have used Tylenol sparingly in this way, it’s likely that wouldn’t lead to any of the negative effects that the authors write about in this paper, she adds.
Paper Recommends Warning Labels, New FDA Review
The statement also included recommendations for European and U.S. regulatory agencies, including the following measures:
- Acetaminophen and any drugs that contain acetaminophen should include recommendations for use during pregnancy on the label.
- The FDA and Europe Medicines Agency should conduct new safety reviews of the drug and update recommendations accordingly.
- Additional studies that examine the use of acetaminophen and acetaminophen-containing drugs should be conducted to more accurately determine if and how the drugs should be dosed, for how long, and at what time during pregnancy.
“The time has come for us to reassess what we thought we knew about acetaminophen and to take a more cautionary approach. As we learn more about fetal development and the many medications and infections that can impair normal development, greater caution is warranted,” says Dr. Waldorf.
Neale agrees, saying, “An FDA review of the recent evidence seems appropriate, and further study could provide more clarity about how acetaminophen should be used. What are the real risks of this relationship between using the medication and issues with fetal health — it is just an association or is it causation?”
“We would be remiss if we ignore what’s outlined in this paper,” says Neale. “We want to keep our moms and babies healthy, and we want our babies to grow into young people who can achieve their best potential.”
The 2015 FDA Drug Safety Communication recommendations included acetaminophen in a review of the possible risks of pain medicine use during pregnancy. The agency examined a study that linked attention deficit hyperactivity disorder (ADHD) in children born to women who had taken the drug at any time during pregnancy. At that time, it was determined that the evidence connecting acetaminophen use during pregnancy and ADHD was inconclusive.
Pain Relief in Pregnancy May ‘Need to Evolve’
In bringing to light these potential risks, it may encourage pregnant women to stop and consider if they really need to take the drug or if there could be an alternative way to treat their pain, says Neale.
Waldorf suggests that pain relief in pregnancy may need to evolve more to modalities that don’t involve medication. “This could include physical therapy, massage therapy, ice and heat, and, when necessary, limiting activities. I routinely prescribe physical therapy and massage therapy to my patients, which is underutilized and incredibly helpful,” she says.
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