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Medication Topamax Found to Increase Risk of Fetal Cleft Palate


The federal government has warned of the risk of birth defects from the drug topiramate when mothers are treated with it during pregnancy.

Topiramate is approved by the Food and Drug Administration to treat people for some types of seizures and to prevent migraine headaches. It has also been prescribed for other unapproved reasons such as to treat bipolar disorder. Topiramate is sold under the brand name Topamax and generic versions are also available.

According to the FDA, many millions of prescriptions for this drug have been filled in the U.S.

FDA Announcement

In March 2011, the FDA issued a drug safety announcement about the increased risk of infant cleft lip and cleft palate when mothers take topiramate during pregnancy.

According to the Mayo Clinic, cleft lip and palate are common facial birth defects causing “openings or splits in the upper lip, the roof of the mouth (palate) or both” that can run “into the bottom of the nose.” Resulting problems can include speech impairment, feeding problems, dental problems, ear infection and hearing loss. Although cleft lip and palate can usually be successfully treated surgically, some kids experience the stress of dealing with how their faces look to others.

At that time of the FDA announcement, the agency put topiramate into Pregnancy Category D because of new data from U.S. and U.K. human studies about the increased dangers to babies. This governmental category lists dangerous medications for which “positive evidence of human fetal risk based on human data” exists, but there still may be times when the drug’s therapeutic effects for a particular expectant mother outweigh the risks to the child.

The agency warned that women of childbearing age should carefully consider with their physicians whether taking topiramate is worth the increased risk of birth defects. If a woman takes the drug and becomes pregnant, the medical damage can be done to the fetus before the mother even realizes she is pregnant because the cleft palate or lip happens early in development. Women may want to take reliable contraception along with topiramate for this reason.

The FDA warns that women taking topiramate should not stop without working with their treating physicians, because abruptly stopping the drug can cause uncontrolled seizures. The agency urges women on the medication who become pregnant to register with the North American Antiepileptic Drug Pregnancy Registry, and those whose kids have birth defects while taking topiramate should report this information to the FDA MedWatch program.

Physician Responsibility

According to the announcement, doctors should educate their female patients of childbearing age of the dangers from topiramate to developing fetuses in the first trimester. The risks and benefits of taking the drug during pregnancy should be carefully weighed and women taking it who could become pregnant should use birth control In addition, alternate medicines that might be safer should be seriously explored.

Other Risks

The FDA reports that topiramate has also been known to cause eye damage and vision problems in some patients, as well as suicidal thoughts in about 1 in 500 people taking it.

Anyone who took topiramate during pregnancy and delivered a child with cleft palate or lip should discuss the situation with an experienced medical malpractice attorney, especially if the mother was not adequately informed of this risk.

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