Topamax Linked to Cleft Lip, Cleft Palate

Another medical group is warning patients about the dangers associated with the anticonvulsant medication <"">Topamax (generic: topiramate) when used by expectant mothers. Now, the American Academy of Family Physicians (AAFP) is warning family physicians about the increased likelihood of infants being born with cleft lips or cleft palates in women taking <"">Topamax during pregnancy.

Topamax oral clefts occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women are not aware of their pregnancy.

Late last month, we wrote that The American Headache Society said that women of childbearing age should be careful about using Topamax to treat migraine headaches because of its birth defect risk. The society’s advice followed the U.S. Food & Drug Administration’s (FDA) recent warning that women who take Topamax while pregnant are 20 times more likely to give birth to a child with a cleft lip or cleft palate.

Topamax, made by Johnson & Johnson, is an anticonvulsant medication approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures. Topamax is also approved for use to prevent migraine headaches. The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010.

In February, the FDA changed the pregnancy classification for Topamax from Category C to Category D after data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicated that mothers on topiramate during the first trimester of pregnancy had an increased risk of infants born with oral clefts. The new classification also applies to generic forms of Topamax. The Pregnancy Category D designation means that there is positive evidence of human fetal risk based on human data, but potential benefits in pregnant women may outweigh risks in certain situations.

FDA officials now say that family physicians should be aware of increased oral cleft risks and is urging doctors to teach their female patients of childbearing age about the risks of taking Topamax during pregnancy, wrote AAFP.

According to Jennifer Shepherd, an FDA pharmacist in its Division of Drug Information, “The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death,” quoted AAFP. “Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used,” Shepherd added.

In a March 4 safety announcement, the FDA said doctors should be cognizant of the potential decrease in “hormonal exposure” and “contraceptive efficacy” in women using “estrogen-containing birth control” when taking topiramate, said AAFP. The American Headache Society also advises that women of childbearing age carefully weigh the risks and benefits of Topamax when choosing a migraine treatment and points out that Topamax can impact the efficacy of certain contraceptives that contain estrogen.

Data from the North American Antiepileptic Drug (NAAED) Pregnancy Data indicated that between one and two of every 100 infants (1.4%) exposed to Topamax in utero were born with a cleft lip or palate, compared to 3-5 of every 1000 infants (0.38-0.55%) born to mothers taking other antiepileptic medications during pregnancy, and 7 of every 10,000 infants (0.07%) born to mothers who neither had epilepsy nor took antiepileptic medications. According to the FDA, data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.

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