Daniel Jordan 
FDA Issues Warning on Acetaminophen Use in Pregnancy, Highlights Risks of Other OTC Medications
(CLAIR | Simi Valley, CA) — The U.S. Food and Drug Administration (FDA) announced this week that it will update warning labels on acetaminophen products such as Tylenol. The change reflects growing evidence of a possible link between use during pregnancy and higher risks of conditions like autism and ADHD in children.
The FDA stressed that while acetaminophen remains the only over-the-counter pain reliever generally considered safe in pregnancy, new studies have raised enough concern to warrant precaution.
But acetaminophen is not the only medication that pregnant women need to approach carefully. Many other common over-the-counter drugs can pose risks to a developing baby.
Medications to Avoid
Ibuprofen and Naproxen (Advil, Motrin, Aleve): These nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the risk of miscarriage early in pregnancy and cause heart and kidney problems for the baby later on.
Aspirin: Regular-strength aspirin can interfere with a baby’s development. Low-dose aspirin may be prescribed by a doctor in specific cases, such as to prevent preeclampsia, but should not be taken without medical supervision.
Decongestants like Pseudoephedrine and Phenylephrine (Sudafed and others): These can raise the risk of certain birth defects, especially when used in the first trimester.
Herbal Supplements: Products marketed as natural can still be dangerous. For example, blue cohosh has been linked to newborn heart problems, while pennyroyal and ginseng are considered unsafe.
Studies Behind the FDA’s Decision
Research driving the FDA’s decision includes long-running projects such as the Nurses’ Health Study II and the Boston Birth Cohort, both of which found associations between frequent acetaminophen use in pregnancy and later diagnoses of autism and ADHD.
A 2024 Swedish study published in JAMA reported similar findings but noted that when siblings were compared, much of the risk appeared to be explained by family factors rather than the medication itself.
In 2025, a Harvard T.H. Chan School of Public Health review examined 46 studies. Twenty-seven of them reported positive associations between prenatal acetaminophen exposure and neurodevelopmental disorders, while others found no link. The authors concluded that the evidence was “consistent with an association,” but not conclusive.
Guidance for Simi Valley Families
Doctors in Simi Valley and across Ventura County now face the task of helping families weigh these risks. With about 126,000 residents, many local households will be affected by the FDA’s new guidance.
The FDA advises that pregnant women should always consult their doctors before taking any medication, even if it is available without a prescription. When acetaminophen is needed, the recommendation is to use the lowest effective dose for the shortest period possible.
For more information, residents can call 888-INFO-FDA or visit www.fda.gov
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