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Topiramate is a medicine prescribed to treat certain types of seizures in epileptic patients. It also is approved to prevent migraines. However, it has not been shown to reduce the pain of migraines once they have begun.

The drug is in a class of medications called anticonvulsants. These drugs work by decreasing excessive electrical activity in the brain.

FDA Advisory about Topiramate Birth Defects

On March 4, 2011, the U.S. Food and Drug Administration (FDA) changed the pregnancy classification of the drug from Pregnancy Class C to Pregnancy Class D. The change reflected new findings that the medication caused birth defects in infants born to mothers who took the medication during their first trimester of pregnancy.

Topamax® was found to significantly increase the risk of a baby being born with a cleft lip and/or cleft palate (oral cleft) if the mother took the drug during the first 12 weeks of pregnancy.

The patient medication guide and prescription information are being updated with the new information about birth defects. The new findings were published in the North American Antiepileptic Drug Pregnancy Registry.

The FDA issued a health safety announcement to alert patients and physicians to the new data gathered on the drug. The agency recommended that pregnant women and women of childbearing age should talk to their doctors about other ways to treat their epileptic seizures. The agency advises women to talk to their physicians immediately if they are planning to or do become pregnant.

The FDA announcement also warned women not to suddenly stop taking Topamax® unless their doctors tell them to do so. Immediately stopping topiramate without a physician’s guidance could result in seizures that are dangerous to the woman and her pregnancy.

Drug Formulation

Topamax® comes in tablet and sprinkle capsule form. For patients who have trouble swallowing tablets, the sprinkle capsules may be opened and the contents sprinkled on soft food that should be swallowed immediately without chewing. The tablets have a bitter taste and are meant to be swallowed whole, not split, chewed or crushed.

Some patients lose weight while taking Topamax® and should speak with their doctors if that happens. Patients on the medication should not be on a ketogenic diet. This is a high-fat, low-carbohydrate diet used to control seizures.

Side Effects of Topiramate

The medication can cause numerous side effects, including:

• Numbness, burning, or tingling of the hands or feet
• Delayed reactions
• Problems concentration
• Problems with speaking, especially remembering specific words
• Problems with memory
• Coordination problems
• Confusion
• Nervousness
• Aggressiveness
• Irritability
• Moodiness
• Depression
• Headache
• Sleepiness
• Weakness
• Excess movement
• Uncontrollable shaking of part of the body
• Uncontrolled eye movements
• Excessive thirst
• Weight loss
• Constipation
• Diarrhea
• Gas
• Heartburn
• Less able to taste food
• Tongue swelling
• Overgrowth of the gums
• Dry mouth
• Increased saliva
• Nosebleeds
• Tearing
• Dry eyes
• Back, muscle, or bone pain
• Skin difficulties or changes in color
• Dandruff
• Hair loss
• Hair growth in unusual places
• Ringing in the ears
• Swelling of the hands, arms, feet, lower legs
• Difficulty or pain when urinating

"Topamax® May Cause Birth Defects, Says FDA"

The FDA notified healthcare professionals and patients about a possible connection between Topamax® and certain birth defects. The agency sent a letter...

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