Topamax is a drug that has been used to prevent seizures and migraines. On March 4, 2011 the FDA announced that Topamax was linked to the development of birth defects like cleft palate and cleft lip in babies. If you or a loved one took Topamax during pregnancy and the baby was born with a cleft palate or cleft lip then it is likely they are related.
Topamax was approved by the FDA on December 24, 1996. The drug is commonly characterized as being an anticonvulsant drug, which helps to prevent epileptic seizures. Topamax has also been given for treatment of depression, bipolar disorder and other mental health issues. The drug was initially produced by Johnson & Johnson but can also be found in its generic form reproduced by other companies as well as topiramate. Over 20 years since it was released on the market the FDA finally answers the question of what causes cleft palate.
The FDA announced that the drug has the clear potential to increase birth defects in infants. Many women who took the drug gave birth to infants with cleft lip and cleft palate.
What is cleft lip and cleft palate?
If the cleft does not affect the palate structure of the mouth it is referred to as cleft lip. Cleft lip is formed in the top of the lip as either a small gap or an indentation in the lip (partial or incomplete cleft) or it continues into the nose (complete cleft). Lip cleft can occur as a one sided (unilateral) or two sided (bilateral). It is due to the failure of fusion of the maxillary and medial nasal processes (formation of the primary palate).
Cleft palate is a condition in which the two plates of the skull that form the hard palate (roof of the mouth) are not completely joined.
Palate cleft can occur as complete (soft and hard palate, possibly including a gap in the jaw) or incomplete (a ‘hole’ in the roof of the mouth, usually as a cleft soft palate). When cleft palate occurs, the uvula is usually split. It occurs due to the failure of fusion of the lateral palatine processes, the nasal septum, and/or the median palatine processes (formation of the secondary palate).
Topamax is a drug that has been used to prevent seizures and migraines. On March 4, 2011 the FDA announced that Topamax was linked to the development of birth defects like cleft palate and cleft lip in babies. If you or a loved one took Topamax during pregnancy and the baby was born with a cleft palate or cleft lip then it is likely they are related. Call us at 1-800-810-3467 to speak to someone that can help.