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Advil Lawsuits


Recently, research published in the Journal of Obstetrics and Gynecology found that mothers who used NSAID painkillers (inclding Advil) had a greater risk of having a baby with one of the following severe, debilitating birth defects: cleft lip, cleft palate, spina bifida, clubfoot, amniotic band syndrome, and two conditions that cause blindness.


September 17, 2012 — Advil has been associated with an increased risk of hearing loss. Click here to read more.

Advil Overview

Advil is a medication used for the treatment of mild to moderate pain, reduction of fever, and several chronic arthritic conditions. The active ingredient in Advil is ibuprofen, a type of anti-inflammatory drug that has been available in the U.S. since 1974. Advil is manufactured by Pfizer and has been available since 1984.

Advil and other NSAIDs work by inhibiting an enzyme that produces prostaglandins. Prostaglandins are necessary for pain, fever, and inflammation. By blocking these enzymes, Advil and other NSAIDs reduce pain and fever. As a class of medications, NSAIDs are some of the most popularly used medications in the world. You probably have at least one NSAID floating around in your medicine cabinet — aspirin, naproxen, and ibuprofen are some of the most common NSAIDs. These medications have a long history of use, so many people may believe that they are always safe to use. Unfortunately, recent research suggests that NSAIDs and Advil during pregnancy may increase the risk of having a baby with a birth defect.

Advil and Pregnancy

What birth defects have been linked to Advil?

  • Clubfoot: This occurs when the baby is born with one or both feet turned inward and downward at a sharp angle. Though it looks like this condition is caused by the way a baby develops in the womb, it is actually caused by abnormal development of the calf muscles, tendons, and ligaments in a baby’s foot. About half of cases involve both the baby’s feet, called “bilateral clubfoot.” Modern treatment has greatly improved, and children rarely undergo extensive surgery. In the Ponseti method, the baby’s foot is gradually stretched and casted into position. Usually, by the time the child is learning how to walk, the birth defect has been corrected.
  • Amniotic Band Syndrome (ABS): Children born to mothers who took an NSAID were three times more likely to suffer from ABS. This condition is thought to arise when there are ruptures to the amniotic sac, which is the sac that surrounds a developing baby in the womb. Fibrous bands of the sac float around in the amniotic fluid, and a developing baby can become entangled. The severity of ABS depends on what part of the baby is entangled and how tightly the bands are constricting the child. In severe cases, the child may suffer amputations caused by constricted bands.
  • Spina Bifida: This birth defect was 60% more likely to occur in children born to mothers who took an NSAID during pregnancy. Though most babies with spina bifida actually have no disability, in severe cases, children are born with paralysis and incontinence and they must use a wheelchair. Severe spina bifida occurs when the neural tube that normally protects the spinal cord fails to close during the first few weeks of fetal development. Damage to the exposed spinal cord cannot be cured.
  • Anophthalmia and Microphthalmia: These exceptionally rare birth defects are three times more likely to occur to children whose mothers took an NSAID during pregnancy. They may occur in just one eye or both eyes. Anophthalmia is the condition of being born with no eye tissue, leaving the child irreparably blind. Microphthalmia occurs when the child’s eyes are significantly smaller than usual.
  • Cleft Lip and Palate: These orofacial clefts were 30-80% more likely in children whose mothers took an NSAID during pregnancy. Babies born with clefts often have problems eating, sucking, and swallowing. In severe cases, babies must undergo multiple-stage surgeries to improve their facial appearance and improve their ability to eat normally.

Scientific Study of NSAIDs, Advil and Pregnancy

In December 2011, the Journal of Obstetrics and Gynecology published the results of a study that found a link between painkillers and birth defects. The researchers analyzed data on more than 20,000 women and looked for links between painkillers and 29 different birth defects. The good news is, most birth defects were not linked at all. Unfortunately, a few birth defects were linked to the maternal use of painkillers, and these birth defects were severe, debilitating, and sometimes deadly.

The conclusions of the study were based on information from 15,000 women whose babies had birth defects. The mothers all participated in the National Birth Defects Prevention study. The researchers analyzed this data, and compared it to data from 5,500 women whose babies had no birth defects. The researchers found that the maternal use of painkillers early in pregnancy increased the risk of having a baby with clubfoot, anophtalmia, microphthalmia, spina bifida, cleft lip, cleft palate, and amniotic band syndrome.

The researchers concluded that women who are pregnant should talk to their doctor about safe painkillers to take during pregnancy.

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