Label Changes for:

Topamax (topiramate) tablets and sprinkle capsules

December 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

March 2011

WARNINGS AND PRECAUTIONS

Fetal Toxicity
  • Topamax can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.
  • Consider the benefits and the risks of TOPAMAX when administering this drug in women of childbearing potential, particularly when Topamax is considered…

ADVERSE REACTIONS

Other Adverse Reactions Observed During All Epilepsy Clinical Trials
  • Central & Peripheral Nervous System Disorders: hyperesthesia

USE IN SPECIFIC POPULATIONS

Pregnancy
  • Pregnancy Category D
  • TOPAMAX can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk for cleft lip and/or cleft palate (oral clefts). When multiple species of pregnant animals received topiramate at clinicallyrelevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. Topamax should be used during pregnancy only if the potential benefit outweighs the potential risk. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Pregnancy Registry
  • Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1- 888-233-2334. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/.
Human Data
  • Data from the NAAED Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other AEDs, and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment…

 

December 2009 

 

WARNINGS AND PRECAUTIONS

Withdrawal of Antiepileptic Drugs (AEDs)
  • In patients with or without a history of seizures or epilepsy, antiepileptic drugs including Topamax should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency. In situations where rapid withdrawal of Topamax is medically required, appropriate monitoring is recommended.

PATIENT COUNSELING INFORMATION

Eye Disorders
  • Patients taking Topamax should be told to seek immediate medical attention if they experience blurred vision, visual disturbances or periorbital pain.

 

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