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Topamax® and Pregnancy

Women, who are either currently pregnant or considering becoming pregnant, are now cautioned to read and understand the possible effects of Topamax®, a medication employed to treat epileptic seizures and migraine headaches. Several healthcare providers suspect that Topamax® might result in birth defects like cleft lip and also cleft palate. Similarly, they encourage women who are using Topamax® and also have the potential to become pregnant to use barrier-based contraceptive methods in order to minimize the potential of becoming pregnant.

FDA Warnings

Recently, the FDA also echoed concerns of Topamax and it’s associated dangers of causing cleft lips and cleft palates in newborns. Used as both a medication for epilepsy as well as headaches, Topamax is often used by women who may not know they are pregnant and are in their first trimester. This is why healthcare agencies are urging women who are on Topamax and are within their child birthing years to use the proper means of preventing pregnancy.

Topamax® and Birth Control

Education of Topamax and its effects is something that is emphasized by the American Headache Society (AHS). As well as the push for education concerning the potential birth defects attributable to Topamax, the AHS wants women to understand that Topamax may also lower birth control pill effectiveness, and is advocating women to utilize physical contraceptive methods as an alternative. Diaphrams are one such example, but AHS states that progesterone-only pills and progesterone-based IUDs are also options. For those interested, progesterone injections are one final substitute for standard birth control pills.

About Topamax

As a treatment for uncontrolled seizures, Topamax was initially approved primarily as a medication for epilepsy. However, Topamax was later approved by the FDA in 2004 as a means of treating migraine headaches in addition to Topamax's epilepsy treatment uses. Numerous physicians additionally prescribe Topamax to patients suffering from bipolar disorder, but the doctors do so off-label. Two years following the FDA approval, generic brands of Topamax became available to patients.

Between January 2007 and December 2010, 32.3 million Topamax prescriptions or its generic counterpart were issued, according to the FDA.

Topamax and Birth Defects

Research results made available from the North American Antiepileptic Drug Pregnancy Registry claims that infants born to mothers who used Topamax throughout their pregnancy were roughly three times more likely to have an oral cleft birth defect when compared to the babies of women who took other antiepileptic drugs. The risk of cleft defects skyrocketed to around 20 times higher when a comparison was made relating to the infants born to mothers who used Topamax, and the infants belonging to women who neither had epilepsy nor used other antiepileptic medications.

Cleft lips and palates certainly are a very noticeable problem for children. The condition hinders a child’s capability to both eat and speak. Cleft defects are also correlated to increase the likelihood a child will have ear infections, which often times must be corrected through surgery. Likewise, cleft lips and palates will affect a child’s physical appearance, in that the child will have a notched lip beginning from the nostrils to the roof of the child’s mouth. This is a result of the lip or palate not being able to fully fuse during development.

Topamax Lawsuits

A class-action lawsuit by mothers affected by Topamax and its ability to produce birth defects in newborns is in the works. The lawsuit is on the basis that manufacturers of Topamax didn’t appropriately investigate the effects of the medication on pregnancy or warn of Topamax’s dangers after becoming aware of the risks involved.