New research has found a link between NSAID painkilling medications (including Vioxx) and an increased risk of having a baby with clubfoot, spina bifida, amniotic band syndrome, two eye defects that cause permanent blindness, cleft lip, and cleft palate.
Vioxx (rofecoxib) is a new type of Non-Steroidal Anti-Inflammatory (NSAID) painkilling medication. It belongs to a group of NSAIDs called COX-2 selective NSAIDs, and is similar to Celebrex and Bextra. These powerful painkillers inhibit a substance that is involved in your body’s pain and inflammation response. By inhibiting this substance, the medication is able to reduce pain, inflammation, swelling, and tenderness. Vioxx was usually prescribed to people with osteoarthritis and rheumatoid arthritis, two conditions that are caused by chronic inflammation of the delicate lining between a person’s joints.
Vioxx is also related to the non-selective NSAIDs naproxen and ibuprofen. These are some of the most popular medications in the world. They treat a variety of common ailments, including mild to moderate pain, inflammation, and swelling. Many people also take aspirin, the most popular NSAID, to reduce the chance of developing blood clots that can cause a heart attack.
Unfortunately, these common medications have recently been linked to some serious birth defects.
Vioxx and Pregnancy
In December 2011, researchers found a link between NSAIDs and several life-threatening, debilitating birth defects. The link was most pronounced in women who took an NSAID, such as Vioxx, early in pregnancy. Researchers recommend that women avoid this class of drugs for their entire pregnancy.
- Amniotic Band Syndrome (ABS): This birth defect is thought to occur when bands of the amniotic sac separate, entangle a developing baby, and cause constriction that can lead to amputation, death, or miscarriage. It is often difficult to detect before birth, and is often only diagnosed when the bands cause swelling of the baby’s limbs. The severity of ABS depends on what part of the baby is entangled and how tightly the bands are constricting. ABS is three times more likely to occur in babies born to mothers who took an NSAID during pregnancy.
- Clubfoot: Though it appears that this birth defect is caused by the position of the baby in the womb, it is actually caused by abnormal development of the baby’s calf muscles, tendons, and ligaments. It may affect one foot or both feet. It is visually apparent when the baby is born: one or both feet are turned inward sharply, and may also be pointed downward. The foot may be twisted nearly upside-down. If left untreated, clubfoot can cause severe impediments when the child is learning how to walk, and can cause the child to have an abnormal gait. For this reason, most parents choose to treat clubfoot. The child may undergo surgery to lengthen the abnormally short parts of the foot. Modern treatments also include gradually stretching the foot into a more normal position.
- Spina Bifida: This birth defect was 60% more likely in babies whose mothers took an NSAID during pregnancy. Spina bifida is also known as “myelomeningocele,” or “cleft spine,” and is a birth defect that affects the neural tube. The neural tube normally closes early in fetal development to protect the spinal cord. Sometimes, this tube fails to close. If the baby has an “open” birth defect, the spinal cord is exposed to amniotic fluid in the womb, and the baby will almost always have severe paralysis any may be incontinent. If the baby has a “closed” spina bifida, the child may have no disability. Sometimes, babies with spina bifida are born with a sac sticking out of the mid to lower back where there is an opening in the neural tube.
- Anopthalmia and Microphthalmia: These rare but serious conditions were three times more likely to occur in babies whose mothers took an NSAID during pregnancy. Though the terms are often used interchangeably, these are actually two separate conditions. A baby with anopthalmia is born without eyes; a baby with microphthalmia has abnormally small eyes. There is no treatment or cure for anophthalmia or microphthalmia. These conditions nearly always result in complete or near-complete blindness. Some children benefit from surgical treatment to improve the appearance of the child, including being fitted with a prosthetic eye.
- Cleft Lip (cheiloschisis) and/or Cleft Palate (palatoschisis): These oral / facial birth defects can occur independently or together, and are 30-80% more likely in babies born to mothers who took an NSAID. These birth defects form while the baby is developing in the womb. They may be as minor as a small notch in the upper lip, or as severe as a widely separated upper lip that also involves a cleft palate. A cleft palate may involve only the soft palate, or it may be a severe cleft that involves the hard and soft palate.
Scientific Studies of Vioxx and Birth Defects
The results of a clinical study of birth defects and maternal use of medications was announced in December 2011. The researchers looked at information from 15,000 women whose babies had a birth defect. The researchers compared this information to 5,500 women whose babies had no defects. Then the researchers looked for links between the maternal use of medications and 29 different birth defects. Though the researchers were happy to announce that most of the defects were not associated with the maternal use of medications, unfortunately, a few were. The few birth defects that were associated were exceptionally rare, severe, and debilitating. Because the defects were so rare, even a three-fold increased risk translates to relatively few birth defects numerically. Even so, the researchers said that until the link between NSAIDs and birth defects can be explored further, pregnant women should probably avoid this group of medications.