Recently, the U.S. Food and Drug Administration announced new data which suggests that Topamax increases the chance a baby will be born with oral cleft birth defects, cleft lip and/or cleft palate, if their mother took the antiepileptic drug during her pregnancy. These risks are much less for babies whose mothers were taking other antiepileptic medication or were not taking medication at all while pregnant.
Oral clefts have many serious side effects, and infants born with these oral birth defects often have difficulty eating and gaining weight, which results in poor growth. Children can also suffer recurring ear infections and may have speech problems as a result of the defects.
Surgery is required to repair an oral cleft defect. When an infant is between six and 12-weeks-old, cleft lip repair is done. During the procedure, the baby will be given general anesthesia while a surgeon cuts and shapes the tissues and also sews together the lip. For cleft palate repair, the operation is usually done when a child is older, between nine and 12 months in order for the palate to be allowed to change as they grow. During this process, a surgeon will remove tissue from the roof of the child’s mouth to cover the soft palate while they are under general anesthesia. Often, an additional surgery will be needed to completely close the palate, and depending on their severity of their cleft and their surgery wound, another operation may be required to fix the scarring. In both operations, a surgeon may need to also repair the tip of the baby’s nose, which is called rhinoplasty.
As with any surgery that uses anesthesia, there are risks, which can include an adverse reaction to medication, difficulty breathing, bleeding, and infections. Cleft palate repair operations may also cause the bones in the middle of a baby’s face to grow incorrectly, as well as change the connection between their mouth and nose. Typically, most children heal with few complications.
After the oral cleft surgery, a baby will need to remain in the hospital for five to seven days. A complete recovery can take up to four weeks. The surgery wound will need to be very clean while it heals, and must not have any pressure put on it. In addition, any stretching of the healing area is prohibited for three to four weeks. Until the oral cleft wound is healed, the child will need to be on a liquid diet, and may need to wear an arm splint or cuff to control their arm movement. During this time it is crucial they do not put their hands in their mouth. Following an oral cleft operation, a child may need to see a dentist as their teeth may need to be corrected as they grow in, and may also need to see a speech therapist if there are muscle problems in their palate.
Surgically repairing oral cleft defects can be an expensive and traumatic process for your child and your family. If your child has suffered due to Topamax, call the Topamax cleft palate attorneys at Anapol Weiss. We can help you determine whether you have a valid claim against the drug manufacturer. Call 866-735-2792 today.