Tylenol Birth Defects Risks

Acetaminophen, the main ingredient in Tylenol and other over-the-counter medications, may be linked to birth defects when taken during pregnancy.

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  • Acetaminophen Used During Pregnancy May Be Linked to Birth Defects
  • Research Group Finds Possible Link Between Acetaminophen and Birth Defect
  • Tylenol Use During Pregnancy
  • APAP and Phthalates
  • Acetaminophen as an Ingredient in Medications

Acetaminophen Used During Pregnancy May Be Linked to Birth Defects

Acetaminophen, the main ingredient in the over-the-counter medication Tylenol, is used by over half of pregnant women worldwide and up to 65% in the U.S. Tylenol has traditionally been considered “safe” for use during pregnancy and is widely used for mild to moderate pain and to reduce fevers.

Newly released research shows that the medication may not be as safe as previously thought. Researchers who conducted epidemiological and experimental studies have found that fetal exposure to acetaminophen during pregnancy may increase the risk of certain birth defects including neurodevelopmental, reproductive, and urogenital disorders.

Women or parents of children whose mothers took Tylenol or products containing acetaminophen during pregnancy and whose children were born with neurological, reproductive, or urogenital disorder may be eligible for compensation and should seek legal assistance.

Research Group Finds Possible Link Between Acetaminophen and Birth Defect

A group of scientists recently warned that taking Tylenol or medications containing acetaminophen may increase the risk of certain types of birth defect or developmental disorders. The group recommends that women be advised not to take acetaminophen unless necessary.

An international group of 13 scientists conducted a review of epidemiologic and experimental research which showed that the use of acetaminophen or “paracetamol” as it is called in Europe, may be linked to an increased risk of neurological, urogenital, or reproductive disorders. The research, published in Nature Reviews Endocrinology, examined 25 years’ worth of clinical data and medical literature. The conclusion reached by the 13-member science group was that guidelines for acetaminophen use during pregnancy should be changed.

The conclusion was echoed by the issuance of a joint statement by 91 physicians, scientists, and clinicians from a number of countries including Australia, Brazil, Canada, Israel, Scotland, the U.K., the U.S. and other countries of the EU. The group recommends that pregnant women should not use Tylenol or acetaminophen during pregnancy unless it is medically necessary and that the medication should only be used at the smallest dose, for the shortest time possible.

Tylenol Use During Pregnancy

Tylenol contains acetaminophen, also known as paracetamol or by the name “APAP”. Acetaminophen is also an ingredient in a number of over-the-counter medications such as cough and cold remedies and is an ingredient in certain prescription medications.

Over half of all pregnant women use acetaminophen for mild to moderate pain, as a fever reducer and as part of other over-the-counter medications. Tylenol has long been thought to be “safe” for use during pregnancy, partly because other OTC medications such as ibuprofen and aspirin have long been known to increase the risk of fetal abnormalities, some of which are severe.

While high fever in pregnant women can result in birth defect, most women take acetaminophen for other reasons such as aches, mild pain, or headache. For many women, Tylenol use is so common, it is not thought of as a true medication that can have possible side effects. Research is showing that acetaminophen may have more risk than previously thought.

In addition to the current concerns about neurologic, reproductive and urogenital disorders, previous research has attempted to link Tylenol use to autism, ADHD, intestinal disorder, and other birth defects with mixed results. In some cases, a tenuous link has been made, particularly when high doses were used for long periods of time.

The new study shows that acetaminophen use for less than two weeks total during pregnancy, carried the least risk. Over two weeks showed a greater risk for adverse events.

APAP and Phthalates

Acetaminophen, called chemically N-acetyl-p-aminophenol or APAP, may be chemically similar to a group of synthetic agents called phthalates. Phthalates are used to make plastics more durable and found in numerous personal care, food and consumer products. They do not easily break down but can result in a number of health concerns including asthma, ADHD, diabetes, hormone disorders and other concerns.

APAP or acetaminophen appears to have some similarity to phthalates and may affect the developing fetus in a similar way resulting in neurologic, developmental, reproductive, and urogenital issues, along with other potential disorders. A research survey found, 26 mother-child studies which identified concerns including ADHD, autism spectrum, language delays, decreased IQ and conduct disorders, while others have found urogenital, ovarian, and testicular issues.

No definitive link has been established but the possibility indicates further research is needed and gives reason to restrict acetaminophen use during pregnancy to “only when necessary”. Researchers and pregnancy advocates have indicated a need to see more definitive research that could include objective measures of when during a pregnancy, dosage amounts and length of exposure, in addition to more careful study of problems of infants after exposure.

Acetaminophen as an Ingredient in Medications

In addition to name-brand Tylenol and generic acetaminophen sold as pain and fever remedies, it is a common ingredient in other medications sold over-the-counter and in a number of prescription medications used mainly for pain treatment.

Examples of OTC medications containing acetaminophen:

  • Tylenol
  • Tylenol Cough and Cold
  • Tylenol Sinus
  • Excedrin
  • DayQuil / NyQuil
  • Theraflu
  • Robitussin Multi-symptom
  • Coricidin
  • Advil Dual Action
  • Generic or store brand products

Because the medications are so common, the science groups are recommending that women who are pregnant be advised to “forgo” acetaminophen use whenever possible and to only use it at the lowest dose, for the shortest time when it is medically necessary.

Women or loved ones of children whose mother took Tylenol or products containing acetaminophen during pregnancy, and who were born with a urogenital, reproductive or neurological birth defect, may have been placed at high risk and should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.


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