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Aleve Lawsuits


Aleve birth defects include amniotic band syndrome, clubfoot, cleft palate, cleft lip, spina bifida, anophthalmia and microphthalmia.


Aleve is a common painkiller that belongs to a class of drugs called NSAIDs, which are “Non-Steroidal Anti-Inflammatory Drugs.” Other drugs in this class of medications include: Aspirin, Advil (ibuprofen), Vioxx, Celebrex, Cataflam, Arthrotec, and Nabumetone. These medications inhibit a certain type of enzyme in the body that is involved in inflammation. They are usually prescribed to treat mild or moderate pain, fever, inflammation, and arthritis.

Aleve and Pregnancy

New research has emerged that points to a link between NSAIDs, such as Aleve, and the following severe birth defects:

  • Amniotic band syndrome: This serious birth defect occurs when a developing baby becomes entangled in bands of the amniotic sac while it is developing in the womb. The severity of the problem can be mild, when only fingers are entangled, or it can be life-threatening if the bands are wrapped tightly around the body. The researchers found that mothers who took NSAIDs were three times more likely to have a baby with amniotic band syndrome
  • Clubfoot: This birth defect can severely impair a child’s ability to walk, though treatment is improving. Clubfoot occurs when a baby is born with its foot turned sharply inward, and is not caused by the positioning of the child in the womb. Some children have surgery to correct the condition, and others undergo treatment that involves gradually stretching the foot into the correct position.
  • Anophthalmia and Microphthalmia: These two severe, incurable birth defects cause a baby to be born blind. A baby born with anophthalmia has no eyes, and a baby born with microphthalmia has abnormally small eyes that are blind. Babies were more than three times more likely to suffer this birth defect when their mothers took an NSAID early in pregnancy.
  • Cleft Lip and Cleft Palate: These two birth defects occur when the left and right side of the baby’s lip or the roof of the mouth is separated, forming a cleft. Babies are born with this condition and usually undergo reconstructive surgery to improve physical appearance and improve the child’s ability to eat. The risk of cleft lip and cleft palate was 30-80% higher in babies born to mothers who took NSAIDs such as Aleve during pregnancy.
  • Spina Bifida: This birth defect occurs during fetal development in the womb, and occurs when the neural tube that normally protects the spinal cord has an abnormal opening, which exposes the spinal cord to the amniotic fluid in the womb. Damage to the spinal cord can be mild to severe, but usually results in permanent, lifelong paralysis. The rate of spina bifida was 60% higher for babies born to mothers who took Aleve or NSAIDs during pregnancy

Scientific Study of Aleve and Birth Defects

The research study that found the link between Aleve and birth defects was published in the American Journal of Obstetrics and Gynecology. The researchers took data from the National Birth Defects Prevention study, which included interviews with more than 15,000 women who had babies with birth defects. The researchers compared this information to 5,500 women who had babies without birth defects.

The researchers looked for a connection between the maternal use of medications during pregnancy and more than 29 different birth defects. Though the vast majority of these birth defects had no connection, a few did. This information prompted the researchers to recommend that women who are pregnant or trying to become pregnant refrain from using Advil or other NSAIDs. Instead, they recommend Tylenol, which is generally considered safe. Tylenol is a painkiller that uses a different mechanism than NSAIDs to prevent pain and inflammation.

What is Aleve prescribed for?

Aleve may be prescribed for the following conditions:

  • Relief of pain, tenderness, swelling and stiffness caused by osteoarthritis
  • Rheumatoid arthritis
  • Juvenile arthritis
  • Ankylosing spondylitis (arthritis of the spine)
  • Shoulder pain
  • Tendinitis
  • Menstrual pain
  • Reduce fever
  • Mild headaches
  • Muscle aches
  • Toothaches
  • Backaches

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