Arthrotec Birth Defects Lawsuit

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A new study has found that expecting mothers who take the non-steroidal anti-inflammatory drug (NSAID) Arthrotec (generic: diclofenac) while pregnant have an increased risk of having babies with severe birth defects. Congenital anomalies associated with the maternal use of Arthrotec include spina bifida, clubfoot, cleft palate, amniotic band syndrome (ABS), as well as two severe eye disorders known as anophthalmia and microphthalmia. Due to the severity of these defects, women who are pregnant or may become pregnant should consult their physicians before beginning a regimen of Arthrotec.

Arthrotec & Pregnancy

New research, which was published in the American Journal of Obstetrics and Gynecology, compared the use of NSAIDs among approximately 15,000 women whose babies were born with congenital defects with 5,500 mothers whose infants were not born with defects. The results of the study found that:

  • Infants born to mothers who took ibuprofen or other similar OTC painkillers during pregnancy were three times as likely to be born with no eyes (anophthalmia), or with abnormally small eyes (microphthalmia).
  • A baby’s risk of being born with amniotic band syndrome (ABS) was three times higher if their mothers had taken ibuprofen during pregnancy.
  • The risk of cleft palate rose by up to 80%.
  • Spina bifida birth defects jumped by 60% in babies who had been exposed to the drugs in utero.

According to statistics published by the Centers for Disease Control & Prevention (CDC), anophthalmia and microphthalmia occur in approximately one out of every 5,300 babies born in the U.S., while about one in 10,000 babies are born with amniotic band syndrome each year around the country.

Arthrotec is an over-the-counter NSAID painkiller that works by inhibiting the production of prostaglandins. The drug is a combination of diclofenac, which blocks COX-1 and COX-2 enzymes that promote the inflammatory process, and misoprostol, which protects the lining of the stomach by reducing acid production. Arthrotec has anti-inflammatory, analgesic, and anti-pyretic properties.

In addition to Arthrotec, other pain relievers in the NSAID class include:

Arthrotec Birth Defects

Birth defects linked to Arthrotec by the new study include:

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