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Arthrotec has been linked to an increased risk of having a baby with clubfoot, spina bifida, cleft lip, cleft palate, amniotic band syndrome, and more.

Arthrotec Overview

Arthrotec is the brand-name of a combination of two drugs: diclofenac and misoprostol. Diclofenac is one of the most popular medications used in the treatment of arthritis. It belongs to a class of drugs known as Non-Steroidal Anti-Inflammatory Drugs, or NSAIDs for short. These medications inhibit an enzyme in the body that is necessary for inflammation and pain. Unfortunately, these enzymes are also necessary to protect a person’s stomach lining and gastrointestinal tract. Many people who were taking an NSAID suffered stomach ulcers and other gastrointestinal problems.

To fix this, the makers of Arthrotec combined diclofenac with another drug: misoprostol. Misoprostol is a synthetic version of the enzyme that diclofenac inhibits, and it replaces this enzyme in the stomach and intestines. It encourages a person’s stomach to produce mucous, which protects the stomach and reduces the rate of stomach ulcers and other problems.

Rheumatoid arthritis and osteoarthritis are painful conditions that occur when the delicate lining between a person’s joints becomes inflamed. NSAIDs treat the symptoms of arthritis by inhibiting the body’s inflammation response.

NSAIDs are some of the most popular, widely-used drugs in existence, and they are used worldwide by millions of people. Other common medications in this class of drugs includes aspirin, naproxen, and ibuprofen. These medications are commonly used in the treatment of mild to moderate pain, inflammation, and to reduce fever. Unfortunately, they have recently been linked to some severe birth defects when women took these medications during pregnancy.

Arthrotec and Pregnancy

Did you know that taking an NSAID or Arthrotec during pregnancy may increase your risk of having a baby with a birth defect? The risk is greatest when a woman took the medication early in pregnancy. The following birth defects have been linked to the maternal use of NSAIDs, including Arthrotec:

  • Amniotic Band Syndrome (ABS): This condition increased by a three-fold rate in babies born to mothers who took an NSAID. ABS is caused when the amniotic sac ruptures, fibrous bands of the amniotic sac float in the amniotic fluid, and an unborn baby becomes entangled in the bands. ABS can be particularly devastating to an unborn baby because it is very difficult to detect. Most ultrasounds do not catch ABS until the baby is entangled and the bands begin causing swelling of the baby’s limbs.
  • Clubfoot: This is a congenital birth defect that affects one or both feet. If it affects both feet, it is called “bilateral clubfoot.” Without treatment, a child with clubfoot will appear to walk on their ankles or the side of their foot. Fortunately, clubfoot is a readily treatable condition. Extensive surgery is rarely required. A relatively non-invasive treatment that is becoming standard therapy is called the Ponseti method, in which the child’s foot is gradually stretched and casted into position over the course of several years.
  • Anophthalmia and Microphthalmia: These defects were three times more likely when a mother took an NSAID during pregnancy. Anophthalmia refers to a complete absence of the eyes at birth. Microphthalmia is a term that can describe many defects, but is essentially an eye that is much smaller than normal. Either of these conditions may only affect one eye, or both eyes. Treatment usually involves surgery to improve facial appearance. Children are often fitted with a prosthetic eye.
  • Spina Bifida: The rate of this birth defect was 60% higher when mothers took Arthrotec or another NSAID during pregnancy. Most cases of spina bifida do not cause severe problems. The severe forms are relatively uncommon, and occur when the neural tube fails to close, and the spinal cord is exposed to the environment. The spinal cord may be severely, permanently damaged, causing paralysis.
  • Cleft Lip and/or Cleft Palate: Orofacial clefts are birth defects in which there is a gap in the upper lip or the roof of the mouth. These birth defects occur early in fetal development (during the first three months of pregnancy) and are present when the baby is born. Cleft lip may involve only the upper lip, or the nose, gums, and the palate. A cleft palate may also vary in size. Babies born with this condition are at risk of nutritional deficit, because they often cannot suck properly and cannot obtain enough nutrition from breastfeeding alone. The rate of cleft lip and cleft palate rose by 30-80% when a mother took an NSAID during pregnancy.

Scientific Studies of Arthrotec and Birth Defects

The American Journal of Obstetrics and Gynecology published research in December 2011 regarding the link between Arthrotec, other NSAIDs, and birth defects. Though the link between NSAIDs and birth defects needs to be explored more fully with further research, the researchers have concluded that pregnant women should consider this a warning, and they should talk to their doctor about taking other painkillers during pregnancy to minimize the risk to their unborn baby.

The analysis was based on information that was collected on 15,000 women whose babies had birth defects. The women all participated in the National Birth Defects Prevention study. The researchers took this information and compared it to data on 5,500 women whose babies had no birth defects. Then, the researchers looked for links between the maternal use of painkillers and 29 different birth defects. Though most of the birth defects had no link to painkillers, seven rare but severe birth defects were linked to the maternal use of NSAIDs.

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