Topamax Pregnancy Risks Lead to Guidelines for Headaches and Migraines

A group of healthcare providers dedicated to the study and treatment of headaches is warning women of childbearing potential who are suffering migraines about the potential pregnancy risks with Topamax, and indicate that barrier-based contraceptives should be used to avoid getting pregnant while on the anticonvulsant and limit the risk a Topamax birth defect, such as a cleft lip or cleft palate. 

Earlier this month, the FDA issued a drug safety communication about the risk of cleft lip or cleft palate from Topamax. Use of the epilepsy and migraine medication during the first trimester of pregnancy, when many women do not even know they are pregnant, could cause babies to born with the serious malformations from side effects of Topamax.

In a statement issued last week by the American Headache Society (AHS), the group stressed the importance of women being informed about the risk of pregnancy on Topamax. In addition, AHS warned that Topamax can reduce the effectiveness of birth control pills, and recommended that women who feel that they have to take Topamax consider using a physical form of birth control, such as a diaphragm. The group also said that progesterone-only pills, progesterone-based IUDs and progesterone injections might also be options.

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.

According to data from the North American Antiepileptic Drug Pregnancy Registry, children born to mothers who took Topamax while pregnant had an oral cleft birth defect about three times more often than infants born to women who took other antiepileptic drugs. However, when compared to children born to women without epilepsy or treatment with other antiepileptic drugs, the Topamax pregnancy risk was associated with a 20 times greater prevalence of cleft palate or cleft lip.

Cleft palate and cleft lip birth defects 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.