Vioxx Birth Defects Lawsuit

The now-banned over-the-counter painkiller Vioxx (generic: rofecoxib) has been linked in a recent study to a variety of severe birth defects in babies born to mothers who took the drug during pregnancy. Birth defects associated with Vioxx include cleft palate, spina bifida, clubfoot, amniotic band syndrome (ABS), and two severe eye conditions known as anophthalmia and microphthalmia. Even with proper treatment, many of these defects will result in permanent impairment and lifelong disabilities.

Vioxx & Pregnancy

The new research, which was published in the December 2011 issue of the American Journal of Obstetrics and Gynecology, found that Vioxx and other similar OTC pain relievers have the potential to cause the following birth defects when taken by expecting mothers during their second trimester of pregnancy:

• Amniotic Band Syndrome (ABS)
• Clubfoot
• Anophthalmia
• Microphthalmia
• Cleft Palate
• Spina Bifida

Specifically, the results of the study indicated that babies were three times as likely to be born with no eyes (anophthalmia), or with abnormally small eyeballs (microphthalmia) if their mothers had taken aspirin or naproxen during pregnancy. The risk of amniotic band syndrome (ABS), a rare birth defect that often leads to clubfoot, was also tripled among expecting mothers who took OTC painkillers during their pregnancies. Cleft palate risks rose by 30 to 80 percent, and the risk of spina bifida, a congenital abnormality that occurs when the spinal cord fails to develop properly in the womb, jumped by 60 percent.

Vioxx was a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis, acute pain, and painful menstrual cycles. The drug was designed to work by reducing substances in the body that cause inflammation, pain and fever. In 2004, Merck voluntarily recalled Vioxx nationwide after the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial found that the drug has been linked to an increased risk of cardiovascular events such as heart attack and strokes during chronic use.