Researchers have found a link between the maternal use of NSAIDs, including Vioxx, and some severe, life-threatening birth defects. Some of these birth defects include spina bifida, clubfoot, cleft palate, cleft lip, amniotic band syndrome, and two severe eye defects that cause incurable blindness.
Vioxx was withdrawn from the U.S. market in September 2004 after it was shown that long-term use could increase a user’s risk of a deadly or debilitating heart attack or stroke. If you took Vioxx while you were pregnant and your baby had a birth defect, you may still have time to file a Vioxx lawsuit and receive compensation for your baby’s injuries.
Vioxx (rofecoxib) is a prescription medication used to treat the symptoms of arthritis, rheumatoid arthritis, acute pain in adults, and painful menstrual cycles. It belongs to a new class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs for short). It is a selective COX-2 inhibitor, which means that it selectively inhibits a protein that is involved in the body’s inflammation and pain response. Other COX-2 selective NSAIDS include Celebrex and Bextra. These medications are closely related to non-selective NSAIDs, such as naproxen and ibuprofen.
NSAIDs are some of the most popular, widely-used medications in the world, and you probably have at least one in your medicine cabinet. Unfortunately, new research has recently discovered that there may be a link between NSAIDs taken during pregnancy and a variety of severe, life-threatening birth defects.
Vioxx and Pregnancy
In December 2011, new research emerged that linked the maternal use of NSAIDs, including Vioxx, to several serious birth defects.
- Amniotic Band Syndrome (ABS): This complication occurs when parts of the amniotic sac separate, entangle the developing baby, and cause constricting rings around fingers, arms, or legs. The severity of ABS depends on the part of the baby that is entangled and how tightly it is wrapped in the bands. Severe cases can cause amputation of body parts. ABS is also thought to cause miscarriages, and is highly associated with other birth defects. ABS is three times more likely to occur in babies born to mothers who took an NSAID during pregnancy.
- Clubfoot: This birth defect develops while the baby is in the womb and is present at birth. It is visually apparent as soon as the baby is born. One or both feet are turned inward at a sharp angle at the ankle, so the baby’s foot resembles a club. The foot may also be turned downward. It occurs when parts of the calf muscle, ligaments, and tendons are shorter than normal, and is not caused by the position of the baby in the womb. It can be treated with surgery or gradual stretching of the foot into a normal position.
- Anopthalmia and Microphthalmia: These are rare but severe birth defects affecting the eyes, and they are three times more likely to occur in babies born to women who took an NSAID during pregnancy. Though the terms “anophthalmia” and “microphthalmia” are often used interchangeably, they refer to separate conditions. A baby with anophthalmia has no eyes, whereas a baby with microphthalmia has abnormally small eyes. Sometimes, babies with microphthalmia have some rudimentary vision, though they always have some impairment. Most children born with these conditions are blind.
- Spina Bifida: This severe, debilitating birth defect is almost always associated with some level of paralysis. The rate of spina bifida is 60% higher in babies born to mothers who took an NSAID during pregnancy. Spina bifida is a birth defect that occurs within the first few weeks of fetal development, when the neural tube is closing to protect the spinal cord. A baby born with spina bifida may have an opening at the base of his or her skull, where the spinal cord is exposed to the elements. This exposure almost always causes severe, irreparable damage to the spinal cord, which results in permanent paralysis.
- Cleft Lip, Cleft Palate: The rate of oral clefts and facial clefts increased by 30-80% when mothers took an NSAID while pregnant. A “cleft lip” is a birth defect that occurs when the flesh on the upper lip fails to fuse together. There may be a wide separation or just a small notch in the upper lip. In severe cases, the cleft lip extends into the baby’s nose. Surgical repair of a cleft lip may need to be done in several stages as the child ages. Cleft palate and cleft lip may occur independently or together. Cleft palate affects the roof of the baby’s mouth, and may cause severe problems with eating, sucking, and swallowing. Fortunately, these birth defects can be treated very successfully through modern surgical techniques.
Scientific Studies of Vioxx and Birth Defects
Researchers announced the link between NSAIDs and birth defects in December 2011. They cautioned that the risk of having a baby with one of these birth defects is still very small, but women who are pregnant should probably avoid all NSAIDs until more research can explore the possible link more thoroughly.
The researchers looked for links between maternal use of medications and 29 different birth defects. Most of the birth defects were not associated with any medications. Some were, however. The researchers compared the use of painkillers among 15,000 women whose babies had birth defects, versus 5,500 women whose babies had no defects. Though the results of the study do not prove that there is a conclusive link, the researchers say that they are a warning sign.