Contraindicated

US FDA pregnancy category: Not assigned

Risk Summary: This drug may cause fetal harm; data from a pregnancy registry and epidemiologic studies have shown an increase in oral clefts with first trimester exposure to topiramate; animal studies have shown structural malformations, including craniofacial defects and reduced fetal weights in offspring of multiple species of pregnant animals administered topiramate at clinically relevant doses.

Comments:
-Pregnancy testing is recommended prior to initiating and monthly during therapy; women of childbearing potential should use effective contraception during therapy.
-Patients should be advised that concomitant use with combined oral contraceptives (COC) may cause irregular bleeding; patients should be advised continue taking COC and contact their healthcare provider if irregular bleeding occurs.

In multiple animal species, topiramate administration during the period of organogenesis has been shown to cause developmental toxicity, including teratogenicity at clinically relevant doses. In pregnant women, data from the North American Anti-Epileptic Drug (NAAED) Pregnancy Registry and several large epidemiologic studies have shown an increased risk of oral clefts with topiramate use. Metabolic acidosis has been reported and while topiramate-induced metabolic acidosis has not been studied during pregnancy, metabolic acidosis during pregnancy due to other causes can cause decreased fetal growth, decreased fetal oxygenation, and fetal death. Maternal weight loss is not recommended during pregnancy as it may result in fetal harm. Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians and pregnant women are encouraged to register by calling 1-888-998-4887.

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

Not recommended

Excreted into human milk: Yes
Excreted into animal milk: Data not available

Comments:
-Due to the potential for serious adverse reactions in breastfed infants with maternal phentermine use (e.g., irritability, hypertension, vomiting, tremor, weight loss, and sleep changes), breastfeeding is not recommended during therapy with this combination drug.

See references