Topamax Cleft Palate

Topamax, also known by the generic name Topiramate, is an anticonvulsant used to treat adults with epilepsy who have certain types of seizures. Topamax is also approved to prevent migraines; less commonly, a physician may prescribe Topamax to treat the symptoms of bipolar disorder. Recently, the FDA has announced a revised Topamax cleft palate warning that consumers should be aware of.

New Topamax Cleft Palate Warning

In March 2011, the FDA released a safety alert to health care professionals and Topamax patients regarding the use of Topamax by women who are pregnant or of childbearing age. New data indicate that pregnant women who take Topamax are at an increased risk of giving birth to children afflicted by cleft lips and/or cleft palates. The Topamax birth defects data was released from the North American Antiepileptic Drug Registry. The new labeling recommendations by the FDA places Topamax in Pregnancy Category D. Category D is reserved for medications that have shown positive evidence in regard to fetal injury. Topamax was previously listed as Category C; Category C drugs have shown potential for fetal injury during animal testing phases, but adequate Topamax cleft palate data pertaining to humans was not available at the time of approval. Similar Topamax cleft palate statistics have been noted by registries in the United Kingdom.

Women at Greatest Risk

Any woman who is of childbearing age or who is pregnant is at an increased risk of giving birth to a child with a cleft palate or oral cleft if she is taking Topamax. Topamax cleft palate side effects occur  in developing fetuses very early on in a pregnancy, usually before the woman even realizes she is pregnant; therefore, it is advisable that women who are thinking of becoming pregnant discuss possible drug alternatives and Topamax cleft palate risks with their physicians if they are taking Topamax. Women of childbearing age who do not wish to become pregnant should begin taking birth control. Because Topamax may affect the efficiency of certain birth control methods, women should discuss the best birth control method with their physicians. It is believed Topamax may pass through breast milk and harm an infant. Women who are breastfeeding should not take Topamax unless its use has been discussed with a physician.

It is strongly recommended that pregnant women who are taking Topamax not stop therapy without first contacting their doctors, as sudden ceasing of therapy may cause serious problems despite Topamax cleft palate risks.

When it’s Too Late

If a baby is born without an oral cleft, he or she will never develop one. Topamax cleft palates and lips occur during in utero development, not later in infancy. Unfortunately, for some women the news of Topamax cleft palate risks has come too late. Although a Topamax cleft palate may be repaired with surgery in the first year of a child’s life, the medical expenses associated with a Topamax cleft palate may be very high. For some families, the associated bills may not be affordable. Topamax has been on the market in the United States since 1996, so women who have been taking it since this time may have given birth to a child with an oral cleft and not known why. If you have taken Topamax since 1996 and given birth to a child with a Topamax cleft palate or Topamax cleft lip, or you are currently pregnant and taking Topamax, you may be eligible for a Topamax lawsuit to receive compensation related to your incurred medical expenses.