Naproxen Birth Defects Lawsuit

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A recent study conducted by researchers at the Centers for Disease Control and Prevention (CDC) has found that expecting mothers who take naproxen and other similar over-the-counter painkillers during pregnancy have an increased risk of giving birth to babies with serious congenital abnormalities. Birth defects linked to naproxen include clubfoot, cleft palate, spina bifida, anophthalmia, microphthalmia, and amniotic band syndrome. If you took naproxen while pregnant and gave birth to a baby with any of these defects, you should contact Schmidt & Clark, LLP to discuss your legal options immediately.

What’s the problem?

The new research, which was published in the American Journal of Obstetrics and Gynecology, consisted of a series of interviews with new mothers around the country. These women were asked a number of questions about the types of medications they took during their first trimester of pregnancy (a time when many of the women were still unaware they were pregnant). Included were questions about common over-the-counter painkillers like naproxen, aspirin and ibuprofen.

Naproxen belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs) that are designed to work by reducing hormones that cause inflammation and pain in the body. NSAIDs are used to treat pain and inflammation caused by such conditions as arthritis, tendinitis, bursitis, gout, or menstrual cramps. Naproxen is sold under various brand names including Aleve, Anaprox, Naprelan and Naprosyn.

The CDC study compared the use of NSAIDs among 15,000 mothers whose children were born with birth defects with 5,000 women whose babies were born with no such congenital abnormalities. The results found significant increases in a number of different birth defects. The risk of babies being born with cleft palate increased from 50 to 80 percent compared to women who did not take NSAIDs during pregnancy, while the risk of spina bifida jumped 60%. However, the most troubling statistic found that children born to mothers who took naproxen or aspirin during pregnancy were more than three times more likely to be born without eyes (anophthalmia), or with eyes that were abnormally small (microphthalmia).

Naproxen Birth Defects

The maternal use of naproxen during pregnancy has been associated with the following congenital birth defects:
Amniotic Band Syndrome (ABS) – Rare condition caused by strands of the amniotic sac that separate in utero and entangle digits, limbs, or other parts of the developing fetus. it is believed that ABS occurs when the inner membrane (amnion) tears, leaving the fetus exposed to the floating tissue from the ruptured amnion. ABS is commonly found accompanied by other birth defects such as clubfoot.

Clubfoot (congenital talipes equinovarus) – Birth defect characterized by the feet being rotated inward at the ankle. Clubfoot can occur in one or both feet, with the affected extremity being smaller than normal and difficult to place in the correct position. The calf muscle and foot may also be smaller than normal.

Anophthalmia (also known as anophthalmos) – Congenital absence of one or both eyes. The absence of the eye will cause a small bony orbit, a constricted mucosal socket, short eyelids, reduced palpebral fissure and malar hypoplasia. Anophthalmia is an extremely rare birth defect, and has been reported to be present in approximately 3 out of every 100,000 live births in the United States.

Microphthalmia (also known as microphthalmos, nanophthalmia or nanophthalmos) – Developmental disorder in which a baby is born with abnormally small eyes. In most cases, microphthalmia leads to blindness later in life. The incidence of microphthalmia is approximately 14 per 100,000 live births, and affects between 3 and 11% of blind children.

Cleft Palate – Cranial malformation that occurs when part of the lip doesn’t completely fuse together early in the first trimester of pregnancy. A cleft palate can affect the appearance of the face, and lead to serious problems with feeding and speech. About 1 out of every 2,500 children are born with cleft palate in the United States.

Spina Bifida – Neural tube defect characterized by the failure of the backbone and spinal cord to close before birth. The condition typically occurs in the first trimester of pregnancy, when the two sides of the embryo’s spine fail to join together. Spina bifida has been found to occur in as many as 1 out of every 800 infants.

Naproxen During Pregnancy

The U.S. Food & Drug Administration (FDA) has classified naproxen as a Pregnancy Category C medication, meaning that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans. If you are pregnant or planning to become pregnant, consult your doctor before taking naproxen. Taking naproxen at any time during pregnancy may result in birth defects. Additionally, naproxen can pass into breast milk and has the potential to harm a nursing baby. Do not give naproxen to a child under the age of two without your doctor’s consent.

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