The anti-seizure medication Topamax® (topiramate) will receive a stronger warning to reflect the newly discovered birth defect risk, according to the U.S. Food and Drug Administration (FDA).
The label change follows data that links the medication to the development of facial defects, including cleft lip and cleft palate. Cleft lip and cleft palate are oral malformations that develop during the first several weeks of development.
Cleft lip and palate can occur in the same patient, although it is not always the case. Complications from oral defects can result in difficulty with speech, difficulty eating and ear infections.
Treatment usually requires surgery to repair the cleft in as early as 3 months following birth. Multiple surgeries might be required, depending on the severity of the cleft.
The stronger Topamax® warning will alert female patients of the childbearing age of the birth defect risk. The FDA has asked healthcare providers to inform their patients of the potential risks and to consider other options for females who are thinking of becoming pregnant.
Patients that are not planning on becoming pregnant should take an effective form of birth control, advises the agency.