TOPAMAX for Epilepsy

March 4, 2011 - FDA Drug Safety Communication: TOPAMAX® (topiramate) use during pregnancy can cause fetal harm, including an increased risk for cleft lip and/or cleft palate. For information from the company click here. The FDA announcement can be found at www.fda.gov.

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Read on for valuable information about epilepsy
and TOPAMAX— to help you get the most out of
your treatment.

Attention TOPAMAX Patients and Medical Professionals.

Dispensing errors have been reported between TOPAMAX^® (topiramate) tablets and TOPROL-XL^® (metroprolol succinate) extended-release tablets. Please visit www.RxforSafety.com for complete information, and be sure to check your tablets to ensure you are taking the right medicine.

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About TOPAMAX^®

TOPAMAX^® is approved as initial monotherapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures.

Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials.

TOPAMAX^® is approved as add-on therapy for patients 2 years of age and older with primary generalized tonic-clonic seizures, partial-onset seizures, or seizures associated with Lennox-Gastaut syndrome.

Important Safety Information

Warnings and Precautions

TOPAMAX^® may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness; blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare professional right away if you have any new eye symptoms.

TOPAMAX^® may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Call your healthcare provider right away if you have a high or persistent fever or decreased sweating.

TOPAMAX^® can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired, not feel hungry (loss of appetite), feel changes in heartbeat, or have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with TOPAMAX^®. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, TOPAMAX^® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Pay attention to any changes and call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), or other unusual changes in behavior or mood.

TOPAMAX^® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness.

Do not stop taking TOPAMAX^® without first talking to your doctor. Stopping TOPAMAX^® suddenly can cause serious problems.

If you take TOPAMAX^® during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. There may be other medicines to treat your condition that have a lower chance of birth defects. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPAMAX^®. If the decision is made to use TOPAMAX^®, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX^®. You and your healthcare provider should decide if you will continue to take TOPAMAX^® while you are pregnant. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if TOPAMAX^® has caused metabolic acidosis during your pregnancy. If you become pregnant while taking TOPAMAX^®, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

TOPAMAX^® may cause high blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting.

Taking TOPAMAX^® when you are also taking valproic acid can cause a drop in body temperature (hypothermia) to less than 95ºF, feeling tired, confusion, or coma.

Adverse Reactions

As monotherapy, the most common side effects of TOPAMAX^® (in the 400 mg/day group and at a higher rate, ≥ 5%, than the 50 mg/day group) in adults were tingling in arms and legs, weight decrease, loss of appetite, sleepiness, and difficulty with memory; and in children, fever, weight decrease, mood problems, cognitive problems, infection, flushing, and tingling in arms and legs.

In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX^® in adults (200 to 400 mg/day) were sleepiness, dizziness, loss of muscle coordination, speech disorders and related problems, psychomotor slowing, abnormal vision, difficulty with memory, tingling in arms and legs, and double vision; and in children (5 to 9 mg/kg/day), fatigue, sleepiness, loss of appetite, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease.

Tell your doctor about other medications that you are taking. Report any side effect that bothers you or that does not go away.

These are not all the possible side effects of TOPAMAX^®. For more information, ask your healthcare professional or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information and Medication Guide.

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This site was last modified on: Sep 14 2012 at 10:54:45 EST