It is feared that the use of Topamax during pregnancy will lead to an increased number of birth defects, including cleft lip and cleft palate. The Food and Drug Administration recently changed the class of the prescription drug, categorizing it as presenting potentially significant and unnecessary harm to a human fetus. If a cleft lip is present at birth, the young baby will likely need to undergo surgery to treat the birth defect.
Surgery is needed to Treat Cleft Lip
In order to treat cleft lip, surgery is always necessary. There are many factors as to when a surgery should take place. The doctor will likely consider the child’s health and the cleft lip itself when creating a timetable to engage in surgery. Most doctors have the common belief that a cleft lip should be repaired by the time the baby reaches three to six months of age. The severity of the defect as well as the baby’s health can account for having the surgery earlier or later.
Depending on whether cleft palate is also present, how much of the lip is involved, and whether the baby has any defects of the nose are all factors to be considered in deciding what type of surgery is required. As the child grows older additional surgeries may be used to further correct the defect. Additional surgery can be used to help the mouth adapt and improve the appearance of the scar. The number of surgeries, types of operations, and further treatment often differ depending on the specific facts of each individual case.
Birth Injury Attorneys in New Jersey and Philadelphia
If your child was born with a birth defect, such as a cleft lip or cleft palate, it is likely that you have some questions. Please contact the Mininno Law Office for any questions regarding birth defects or the use of Topamax, or call for a free consultation at (856) 833-0600 in New Jersey, or (215) 567-2380 in Philadelphia.
Cleft lip occurs when the developing tissue of the nose and upper jaw does not fuse normally resulting in a split in the lip. Cleft lip is treatable and generally does not cause health problems although in some more severe cases, children have difficulty feeding. The defect usually occurs on only one side of the upper lip, and very rarely in the lower lip. Cleft lip is visible at birth and beyond the noticeable physical appearance, there are usually no other symptoms.
As data from studies shows the possible correlation between Topamax and cleft lip, the FDA states that there will be a stronger label on the product. The pregnancy category of the drug has been changed. The warning will now show Topamax in category D, as opposed to its former spot in category C. There has been positive evidence of fetal risk in human beings, which is the reason for the change of category.
On March 4, 2011, the