Cleft lip is an oral birth defect that is caused by the failure of the maxillary and medial nasal processes to properly fuse together during fetal development. Cleft lip can range in severity; from a small notch on a baby’s lip or to a complete split in a baby’s lip that goes all the way to the base of their nose. It can be one-sided or two-sided. In most cases of cleft lip, cleft palate is also present. Cleft palate is a birth defect that occurs when the two plates of the skull, which form the hard palate (the roof of a person’s mouth), are not completely joined together. Typically the soft palate is also affected. Cleft palate may also cause a gap in a baby’s jaw or a hole in the roof of their mouth. Often, the uvula is split. Cleft palate can affect one or both sides of a baby’s mouth and sometimes goes the full length of the palate. Together, these oral birth defects are referred to as oral clefts.
There are many serious side effects of cleft lips and cleft palates. Often these defects can cause a baby’s teeth to grow in misaligned, and it can also affect the shape of their nose. Other problems an infant may experience due to their oral cleft include difficulty eating, an inability to properly gain weight, poor growth, speech difficulties, recurrent ear infections, and more.
Recently, the U.S. Food and Drug Administration announced an oral birth defect warning after new data was released regarding a link between cleft lip and cleft palate and Topamax usage. According to the data, babies who are born to women who took Topamax during their pregnancy had a 1.4 percent occurrence rate of oral clefts. This rate is much more than the occurrence rate in babies who were exposed to other antiepileptic drugs, which was found to be between 0.38 and 0.55 percent. Babies who were born to women who did not take any antiepileptic drugs during pregnancy only had an occurrence rate of 0.07 percent. Typically, about 1 out of every 2,500 babies is affected by one or both of these oral birth defects.
According to the FDA, at least 4.3 million patients in the U.S. filled prescriptions for Topamax and its generic versions from January 2007 through December 2010. Many Topamax lawsuits are expected to be filed because of the antiepileptic drug’s extensive use.
Wondering whether you have a valid Topamax lawsuit against the drug manufacturer or negligent healthcare professional who failed to warn you regarding the drug’s dangers? Contact the Topamax lawyers at Anapol Weiss. We can help you decide whether your claim is meritorious. Call 866-735-2792 to learn more.