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Aleve has been linked to the following birth defects: clubfoot, cleft lip, cleft palate, spina bifida, anophthalmia, microphthalmia, and amniotic band syndrome. These birth defects have been linked to mothers who took Aleve during pregnancy.

Aleve Overview

Aleve is one of the most popular painkiller medications available in the U.S. It is a type of mediation called an NSAID, which means “Non-Steroidal Anti-Inflammatory Drug.” The medication works by inhibiting an enzyme in the body that is involved in inflammation, fever, and pain. Many people take Aleve regularly to treat arthritis and mild to moderate pain. Other types of NSAID medications include Aspirin, Advil (ibuprofen), Vioxx, Celebrex, Cataflam, Arthrotec, and Nabumetone.

Aleve and Pregnancy

If you are pregnant or trying to become pregnant, experts warn that you should avoid using these medications, because several reports of Aleve birth defects have been reported. A recent study found a link between NSAIDs (including Aleve) and the following severe birth defects:

  • Amniotic band syndrome: This birth defect can range from mild to severe. It occurs when bands of the amniotic sac (the sac surrounding a developing fetus in the womb) detach, and become entangled in the developing baby. If the bands become wrapped around a finger or a limb, it can cause these appendages to be amputated. If the bands become entangled around the baby’s body, it can be life-threatening. NSAIDs are associated with a three-fold increase in the risk of having a baby with amniotic band syndrome.
  • Clubfoot: This birth defect affects the ligaments and tendons in a baby’s foot, causing the child to be born with a foot that is turned inward at a sharp angle, resembling a club. Treatment may involve surgery, or a gradual stretching of the baby’s foot using bands or casts. If clubfoot is not treated, the child will usually have walking impairments.
  • Anophthalmia and Microphthalmia: These are two serious birth defects of the eye, and always cause a child to be born blind. When a baby is born without eyes, this birth defect is called anophthalmia. When a baby is born with abnormally small eyes that are usually blind, this birth defect is called microphthalmia. Though these two birth defects are very rare, babies born to mothers who took NSAIDs such as Aleve were more than three times more likely to be born with these birth defects.
  • Cleft Lip and Cleft Palate: Birth defects affecting the lip or the hard/soft palate (the roof of the mouth) are some of the most common types of birth defect, and can severely affect the baby’s physical appearance and its ability to feed. Nearly all babies born with these defects must undergo several reconstructive surgeries to repair the defect. Research has found that the rate of cleft lip and cleft palate increases by 30-80% when the mother took an NSAID, including Aleve, during pregnancy.
  • Spina Bifida: This birth defect may be mild, but is usually severe, and can even be life-threatening. Most babies born with spina bifida have some level of paralysis. The birth defect affects the neural tube, which is a tube that normally protects the spinal cord. When the neural tube fails to close during the fetus development, the spinal cord may remain exposed to the amniotic fluid in the mother’s womb. This causes the nerves in the spinal cord to become permanently damaged, and can cause the baby to be born with severe paralysis. The rate of spina bifida was increased more than 60% in babies born to mothers who took Aleve or other NSAIDs during pregnancy.

Aleve Safety Study

In December 2011, researchers announced the result of a new study of the effect of maternal use of Aleve and other NSAIDs on the rate of birth defects. The American Journal of Obstetrics and Gynecology published the researcher’s analysis, which looked for a link between 29 different birth defects and the maternal use of painkillers early in pregnancy. The researchers looked at data from the National Birth Defects Prevention Study, which included 15,000 women who had babies with birth defects. This information was compared to data on 5,500 women with babies who had no birth defects.

The researchers found that there was no link between maternal use of a medication and most birth defects, but a few did have a small link. The researchers stressed that the results of the study were preliminary and more studies were needed to compare results. Because many of the birth defects were quite rare, even a three-fold increase in the incidence translates to relatively few overall cases. Even so, the researchers recommend that women who are pregnant or trying to become pregnant avoid this group of medications.

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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