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Naproxen Lawsuits

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

Overview

Naproxen, also known as “Aleve,” is a painkiller medication. It belongs to a class of drugs called “NSAIDs,” which stands for “Non-Steroidal Anti-Inflammatory Drug.” NSAIDs include naproxen, Aleve, ibuprofen, and aspirin. They are the most commonly prescribed type of medication to treat inflammation, mild to moderate pain, fever, and arthritis. They block a certain type of enzyme involved in pain, fever, and inflammation.

Naproxen and Pregnancy

According to a new study, women who took an NSAID medication had a higher risk of having a baby with the following types of birth defects:

  • Amniotic band syndrome: A birth defect in which strands in the amniotic sac (the sac around a developing fetus in the womb) separate and entangle parts of the fetus. The severity of the birth defect depends on what parts of the baby are entangled and how tightly the bands are wrapped. Babies born to mothers taking NSAIDs such as naproxen were three times more likely to develop amniotic band syndrome
  • Clubfoot: A birth defect in which the baby’s foot is twisted out of shape — usually the foot is turned inward at a sharp angle. Treatment involves surgery or gradually stretching the foot back into the normal position. Babies born to mothers taking naproxen or NSAIDs were three times more likely to develop clubfoot
  • Anophthalmia and Microphthalmia: These birth defects affect the baby’s eye, and occur when the baby is born with no eyes, or eyes that are very small and blind.
  • Cleft Lip and Cleft Palate: These birth defects affect the development of the upper lip or the roof of the baby’s mouth, and occur when the lip or palate are split. The risk of cleft lip and cleft palate rose by 30-80% for women taking NSAIDs or naproxen during the first trimester of pregnancy
  • Spina Bifida: This birth defect occurs when the spinal cord is exposed outside the body, and can lead to severe paralysis. The risk of spina bifida increased 60% for women who took NSAIDs or naproxen early in pregnancy.

Naproxen Safety Study

The results of a new study were published int he American Journal of Obstetrics and Gynecology, and are based on data from women in the U.S. The women were interviewed about the types of medications they used during the first trimester of pregnancy. The researchers compared information from 15,000 women who had babies with birth defects, and 5,500 women who had a baby without birth defects. They looked for links between certain medications and a list of more than 29 birth defects. Relatively few birth defects were linked to the use of NSAIDs, but the researchers still recommended that women avoid this class of medications during pregnancy. Instead, the researchers recommend Tylenol, which works through a different mechanism than NSAIDs and is generally considered safe to use during pregnancy.

The researchers also stressed that these birth defects are relatively rare, so even a two-fold increase is a relatively small increase in overall numbers.

What is Naproxen prescribed for?

Naproxen 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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