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Birth defects linked to Naproxen use during pregnancy include: amniotic band syndrome, clubfoot, cleft palate, cleft lip, spina bifida, anophthalmia, and microphthalmia, and more.

Naproxen Overview

Naproxen is the generic name of the popular medication “Aleve,” and is used by millions of people as a painkiller. Naproxen and Aleve belong to a group of medications called NSAIDs, which is an abbreviation of “Non-Steroidal Anti-Inflammatory Drug.” NSAIDs work by inhibiting an enzyme in the body that is necessary for pain, fever, and inflammation. Other drugs in this class include ibuprofen and aspirin.

Naproxen and Pregnancy

New research has found evidence that links the maternal use of NSAIDs, including naproxen, to several types of birth defects. These birth defects can cause lifelong debilitation. The following birth defects have been linked to NSAIDs:

  • Amniotic band syndrome: This is a birth defect in which parts of the amniotic sac separate, form bands, and become entangled in the fetus developing in the womb. If these strands become entangled around fingers, they may lead to amputation. More serious entanglements can cause death to the child. The risk of amniotic band syndrome was three times higher in mothers who took naproxen
  • Clubfoot: This is a birth defect affecting the foot, in which it is turned inward at a sharp angle, resembling a club. Usually this condition is readily treatable, because the infant’s joints and ligaments are very flexible. Some babies undergo surgery to treat clubfoot; others undergo gradual stretching of the foot to reshape it into a position that will not impede walking.
  • Anophthalmia and Microphthalmia: These are two serious birth defects affecting the baby’s eyes. In anophthalmia, the baby is born with no eyes. In microphthalmia, the baby is born with eyes that are abnormally small and blind. There is no cure or treatment for a baby born with these birth defects. Babies born to months who took naproxen or NSAIDs during pregnancy were three times more likely to suffer these birth defects.
  • Cleft Lip and Cleft Palate: These two birth defects occur when the baby’s upper lip or the hard/soft palate (the roof of the mouth) do not fuse together during fetal development, causing the flesh to be separated. Babies with this birth defect may have serious problems feeding, and almost always undergo surgery. The risk of this birth defect is increased by 30-80% for babies born to mother who took naproxen or NSAIDs early in pregnancy.
  • Spina Bifida: This can be a severe birth defect, causing paralysis and lifelong disability. This birth defect affects the neural tube, which is the tube that protects the spinal cord. When a baby is born with spina bifida, there is an opening in the neural tube and the spinal cord is exposed to the environment, causing mild to severe damage. Spina bifida was 60% more common in babies born to mothers who took naproxen or NSAIDs

Naproxen Safety Study

The researchers who found the link between naproxen, NSAIDs, and birth defects published the results of their analysis in the American Journal of Obstetrics and Gynecology. The data used by the researchers came from the National Birth Defects Prevention study, and compared information from 15,000 women who had babies with birth defects, versus 5,500 women who had babies with no defects.

The researchers looked for links between medication use during pregnancy and more than 29 birth defects. Though the vast majority of the birth defects were not linked to any medication use, some were. Even these were quite rare — so even a three-fold increase translates to relatively few cases numerically. However, the researchers stressed that women who are pregnant or trying to become pregnant should avoid naproxen and other NSAIDs. Tylenol, a painkiller that works in a different way, is generally considered safe to use during pregnancy.

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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