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Topiramate Pregnancy and Breastfeeding Warnings

Topiramate is also known as: Qudexy XR, Topamax, Topamax Sprinkle, Topiragen, Trokendi XR

Topiramate Pregnancy Warnings

UK: -When used for migraine prophylaxis: Contraindicated -When used for seizures: Use only if clearly needed and benefit outweighs potential risk. AU, US: -Use only if clearly needed and benefit outweighs potential risk. AU TGA pregnancy category: D US FDA pregnancy category: D Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age. Comments: -It is recommended that women of child bearing potential use adequate contraception and consider alternative therapeutic options. -This drug should only be prescribed after the patient has been fully informed of the known risks of uncontrolled epilepsy during pregnancy and the potential risks of the drug to the fetus. -This drug should not be used by women of childbearing potential not using an effective method of contraception. -Infants exposed to this drug in the first trimester have an increased risk of congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems).

Animal studies have revealed evidence of teratogenicity, embryotoxicity, and maternal toxicity. When multiple species of pregnant animals received this drug at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. When multiple species of pregnant animals received this drug at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring. -This drug can cause metabolic acidosis. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the ability of the fetus to tolerate labor. There are no controlled data in human pregnancy. Infants exposed to this drug in utero have an increased risk for cleft lip and/or cleft palate. The North American Antiepileptic Drug (NAAED) Pregnancy Registry is collecting information about the safety of antiepileptic drugs during pregnancy. All patients should be encouraged to enroll if they become pregnant. Patients can call the toll free number at 1-888-233-2334 or go to http://www.massgeneral.org/aed/. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Topiramate Breastfeeding Warnings

Breastfeeding infants exposed to this drug showed infant plasma levels of this drug are equal to 10% to 20% of the maternal plasma level.

AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Benefit should outweigh risk. Excreted into human milk: Yes Comments: -If this drug is used during breastfeeding, the infant should be monitored for diarrhea, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.

See references

References for pregnancy information

  1. "Product Information. Qudexy XR Sprinkle (topiramate)." Upsher-Smith Laboratories Inc, Minneapolis, MN.
  2. "Product Information. Topiramate (topiramate)." Cipla USA Inc., Miami, FL.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Trokendi XR (topiramate)." Supernus Pharmaceuticals Inc, Rockville, MD.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Qudexy XR Sprinkle (topiramate)." Upsher-Smith Laboratories Inc, Minneapolis, MN.
  3. "Product Information. Trokendi XR (topiramate)." Supernus Pharmaceuticals Inc, Rockville, MD.
  4. "Product Information. Topiramate (topiramate)." Cipla USA Inc., Miami, FL.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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