Cataflam Birth Defects Lawsuit

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The over-the-counter pain reliever Cataflam (generic: diclofenac) has been associated with a number of extremely serious birth defects in babies born to mothers who took the drug during pregnancy. Defects linked to Cataflam include cleft palate, spina bifida, clubfoot, amniotic band syndrome, and two severe eye conditions known as anophthalmia and microphthalmia. Women who took Cataflam while pregnant and gave birth to a child with any of these conditions may be entitled to compensation for their child’s injuries.

Which birth defects have been linked to Cataflam?

According to research published in the December 2011 issue of the American Journal of Obstetrics and Gynecology, taking Cataflam and other similar non-steroidal anti-inflammatory drugs (NSAIDs) during the first trimester of pregnancy can increase the risk of the following birth defects:

  • Amniotic Band Syndrome (ABS) – Occurs when strands of the amniotic sac tear in the womb and entangle digits, limbs, or other parts of the developing fetus.
  • Clubfoot – Characterized by the baby’s feet being rotated inward at the ankle, with the affected extremities being smaller than normal and difficult to place in the correct position.
  • Anophthalmia – Congenital absence of one or both eyes.
  • Microphthalmia – Baby is born with abnormally small eyes, leading to blindness later in life.
  • Cleft Palate – Occurs when part of the lip fails to fuse together in utero, affecting the appearance of the face and leading to serious problems with feeding and speech.
  • Spina Bifida – Characterized by the failure of the backbone and spinal cord to close before birth, resulting in an incomplete spinal canal.

The study, which was conducted by researchers at the Centers for Disease Control and Prevention (CDC), found that babies were more than three times as likely to be born with these defects if their mothers took NSAIDs like Cataflam during pregnancy.

Manufactured by Patheon, Inc. for Novartis Pharmaceutical Corporation, Cataflam works by reducing substances in the body that cause pain and inflammation. Cataflam is used to treat mild to moderate pain, as well as the symptoms of rheumatoid arthritis and osteoarthritis. It is also commonly used to treat cramping pain in the lower abdomen associated with menstruation.

The CDC research utilized data from the National Birth Defects Prevention Study, which included interviews with new mothers about the medications they took during pregnancy. Among the questions presented in the interviews, the women were asked whether or not they used NSAIDs while pregnant. The researchers then compared the use of painkillers among 15,000 mothers whose children were born with birth defects with 5,500 women whose children were born without defects. According to the results of the study, the risk of developing cleft palate grew by 30 to 80 percent, while the risk of spina bifida jumped by 60 percent.

While the study failed to prove conclusively that NSAIDs caused these birth defects, the results definitely point to the need for further research on the topic. In the meantime, women are strongly urged to consult with their physician to weigh the risks versus rewards of taking Cataflam and other painkillers prior to undergoing a regimen.

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