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A group representing family physicians nationwide is warning its members about the potential danger of cleft palate and cleft lip from Topamax, which can occur when the epilepsy and migraine medication is given to women who are pregnant.
The American Academy of Family Physicians (AAFP) sent out an alert to its members on March 8, shortly after the FDA issued a warning that Topamax has been linked to cleft palate and cleft lip birth defects.
On March 4, the FDA announced that new warnings about the risk of oral clefts from Topamax would be added to the medication’s label after data showed infants exposed to Topamax during the first trimester of pregnancy, when many women do not even know they are pregnant, face an increased risk of cleft lip or cleft palate. The FDA urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy, as alternative durgs may not carry the same risk for the unborn child.
The AAFP represents 97,600 family physicians, medical residents and students nationwide. The organization’s physicians are being urged to educate women of childbearing age about the potential Topamax birth defect side effects and to heed the FDA’s warnings and recommendations regarding use of the drug during pregnancy.
Topamax (topiramate) was first approved for treatment of epilepsy, which is a neurological disorder characterized by recurrent uncontrolled seizures. In 2004, the FDA approved Topamax for an additional use of treating severe headaches known as migraines. It is also used off-label by many doctors to treat bipolar disorder. Generic forms of the drug began to appear in 2006.
The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010.
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.
A number of women who have given birth to children with a defect or malformation after using the drug while pregnant are considering a potential Topamax lawsuit against the drug makers as a result of their failure to research the pregnancy risks associated with the medication or adequately warn about the risk of Topamax cleft palate and lip problems.