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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

American Academy of Family Physicians Warns on Topamax Cleft Palate

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According to a recent posting by the AAFP, Topiramate is linked to infants’ risk for oral birth defects. In its review of the new FDA Warnings for the epilepsy and migraine drug Topamax, AAFP is trying to make family physicians aware so that they can appropriately inform their patients of the risk and can determine if there are more suitable alternative treatments.

The cleft lip and cleft palate problems occur in the first trimester of development of the unborn fetus. Women who use this anticonvulsant during their pregnancy place at risk the unborn child. The FDA is urging doctors to educate women patients of the risk.

The FDA produced a PODCAST to help inform patients of the benefits and risks of topiramate. Since there may be alternative medications for patients and this should be discussed with a doctor to determine what is suitable for each patient.

Jennifer Shepherd, a pharmacist in the FDA’s Division of Drug Information, said, "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. 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."

The AAFP noted that informing patients and weighing risks and beneftis of alternative medications with a lower risk of oral cleft injuries is important. This is particularly important when topiramate is not being used to treat a condition involving permanent irreversible injury or death. AAFP also noted that adverse events should be reported to the FDA. In addition, women on topiramate also need to consider the use approrpiate birth control if they are not intending to become pregnant. However, some data shows the topiramate can compromise the effective of many oral birth control, and thuse alternative forms may be necessary.