Is Tylenol safe during pregnancy? Recent studies have suggested that the use of Tylenol during pregnancy may be associated with the development of neurological disorders in children. Specifically, the exposure to acetaminophen has been linked to the development of autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD).
If you are a parent or guardian of a child who developed ASD or ADHD after the use of Tylenol during pregnancy, you may consider seeking legal advice.
Tylenol and Its Uses
Acetaminophen, the primary active ingredient in Tylenol, is a medication that helps relieve mild to moderate pain caused by headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations, and reduces fever. It can also be used to relieve the pain associated with osteoarthritis. Acetaminophen falls under the class of medications called analgesics, which are pain relievers, and antipyretics, which are fever reducers. Acetaminophen works by changing how the body senses pain and cooling the body.
Health Risks Associated With Acetaminophen
Acetaminophen, which is also known as paracetamol, is a drug that is found in more than 600 over-the-counter and prescription medications, including Tylenol. Overdosing on this drug can cause liver damage, which is the most well-known risk associated with its use.
After taking acetaminophen, the liver metabolizes most of the drug and eliminates it through urination. However, some of the drug is transformed into a toxic metabolite that can harm liver cells. Taking too much acetaminophen increases the risk of liver damage, and in severe cases, it can result in death.
Several studies have linked acetaminophen use to severe skin allergies. According to the FDA Adverse Event Reporting System, between 1969 and 2012, 107 cases of such reactions occurred in the United States, resulting in 67 hospitalizations and 12 deaths. In 2013, the FDA issued a warning that, in rare cases, acetaminophen use can cause potentially fatal skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Is it safe to take acetaminophen during pregnancy? Taking Tylenol or acetaminophen during pregnancy has been found to increase the risk of the child developing autism spectrum disorder, ADHD, and developmental delays.
Recommended Dosage and Frequency
Tylenol is a popular medication available in various forms like tablet, chewable tablet, capsule, suspension or solution (liquid), extended-release tablet, and orally disintegrating tablet. It can also be used as a suppository for rectal use, or in its intravenous form in hospitals.
The medication is available in different doses, usually ranging from 300 mg to 1000 mg. It is available both as a prescription and over-the-counter drug. However, the FDA has limited the strength of acetaminophen in prescription drug products to 325 mg.
For adults, taking no more than 1000 mg at one time is recommended, or a maximum of 4000 mg in a 24-hour period. The recommended dose of acetaminophen ranges from 325 mg to 625 mg, depending on the person and condition treated. Exceeding these limits can lead to serious side effects.
Pregnant women can take a regular adult dosage of Tylenol, which is two capsules or tablets (325 mg each) every 4 to 6 hours while symptoms last. However, they should not take more than 10 capsules (3,250 mg) daily, unless their doctor advises.
What Is the Safety of Tylenol During Pregnancy?
It is generally considered safe to take acetaminophen during pregnancy in moderation, especially during the early stages of pregnancy. However, some studies suggest that long-term use of acetaminophen during pregnancy may lead to complications. Therefore, it is advisable for pregnant women to use Tylenol cautiously and only at the lowest effective dose for the shortest possible time. Using it long-term or in high-doses should be limited to indications as advised by a healthcare professional.
Pregnancy Complications and Precautions
Studies suggest a link between Tylenol use in pregnancy and abnormal baby development. The complications include:
Studies suggest that taking Tylenol during pregnancy may increase the risk of developmental and child behavior issues such as ADHD, autism, delayed talking, and cerebral palsy in children.
One study involving more than 2,600 pregnant women found that for women using acetaminophen during the first 32 weeks of pregnancy, there was a 30% higher chance of children having attention impairments by the age of 5. This is often seen in children who have ADHD or autism spectrum disorder. Tylenol use in the second or third trimester appeared riskier than during the first trimester. Further, the longer Tylenol was used, the greater the risk was. Most studies indicated that short-term use of Tylenol had minimal risk.
Changes in the Reproductive Tract of Unborn Males
There are some studies that suggest taking Tylenol while pregnant can affect the development of the reproductive tract in unborn males. According to these studies, using Tylenol during pregnancy may increase the likelihood of the child having undescended testicles or changes in the genitals’ anatomy. These changes can increase the risk of reproductive problems later in life.
The research suggests that the timing of Tylenol use during pregnancy is crucial. The risk of undescended testicles is at its highest when Tylenol is used in the late first trimester or early second trimester, the time when the reproductive tract forms in an unborn baby. The risk is also heightened when Tylenol is used for more than two weeks during that period.
Regulations and Guidelines in Illinois
When healthcare providers prescribe medication during pregnancy, they take into account whether the drug may lead to abnormalities in fetal development. To help prevent harmful consequences for the developing baby, the U.S. Food and Drug Administration (FDA) has established pregnancy categories that provide guidance on the safety of specific drugs for pregnant women.
Acetaminophen was previously labeled as “Category B,” indicating that no studies had demonstrated that it caused birth defects in animals. However, like many medications, no studies involving pregnant women were performed.
The classification system used to label drugs for pregnant women is getting phased out and replaced with a new rule from the FDA. This new rule requires drug labeling to include a summary of risk, a discussion of the data supporting that summary, and other relevant information to help healthcare providers make informed decisions about prescribing drugs to pregnant women.
The FDA has published a sample drug facts label with recommended warning for Acetaminophen.
The Role of Doctors and Healthcare Providers in Prescribing Tylenol During Pregnancy
It is important for both healthcare providers and patients to take responsibility for ensuring medication safety during pregnancy. If you are pregnant, provide your healthcare provider with a complete list of all medications and drugs you are taking or have recently taken, including prescription and over-the-counter medicines. Your doctor can then help you determine which medications are safe to take during pregnancy and monitor your use of them.
Although many medications can be taken safely during pregnancy without harming the developing baby, some drugs should be avoided. When prescribing medication during pregnancy, healthcare providers must consider whether the drug may cause abnormalities in the child’s development. Therefore, it is the doctor’s responsibility to prescribe medication, including Tylenol, during pregnancy in a way that minimizes the risks of developmental issues for the unborn child.
When Do You Need a Lawyer?
If your child developed Autism Spectrum Disorder or ADHD, you may be eligible to file a lawsuit as their parent or guardian. In case you were prescribed Tylenol while pregnant and your child developed complications, you may be able to claim damages by filing a lawsuit.
Some evidence is necessary to prove your Tylenol lawsuit. You and your lawyer must demonstrate that your child developed complications due to the use of Tylenol during your pregnancy.
You will also have to demonstrate that Tylenol was used during the pregnancy as recommended by a physician, without receiving any warnings of its potential risks during pregnancy.
If your child has been diagnosed with autism spectrum disorder (ASD) or attention-deficit hyperactivity disorder (ADHD) from exposure to Tylenol during pregnancy, you may seek compensation.
The first lawsuits related to Tylenol and its link to autism and ADHD are currently underway in the form of multidistrict litigation (MDL) lawsuits. An MDL lawsuit is similar to a class action lawsuit. A class action lawsuit is one which is filed by multiple plaintiffs who have suffered similar harm caused by one or more defendants. However, the main difference between an MDL and a class action lawsuit is that the former takes place in U.S. district courts, while the latter takes place in federal court.
The lawsuit settlement amounts for Tylenol lawsuits depend on the severity of the symptoms or health effects any lost wages incurred by the parent or guardian due to caregiving responsibilities, the loss of earning capacity for the child, both past and future medical expenses, as well as any pain and suffering experienced.