Increased risk for a birth defects called cleft lip and cleft palate

Qsymia is known as a Pregnancy Category X drug.

 The FDA assigns approved drugs to pregnancy categories to identify drugs that may have additional risks for newborns. They base the decision for each drug on data from animal studies and clinical studies or experience, as it is unethical to perform clinical studies on pregnant women. Pregnancy categories are useful tools for patients and healthcare professionals to weigh the risks and benefits of using a drug during pregnancy. The risk or consuming drugs in Pregnancy Category X during pregnancy clearly outweigh the benefits. For these medications, healthcare providers should advise either a safe delay in treatment or an alternative medication.

According to the drug’s website, “Qsymia can harm your unborn baby. If you take Qsymia while you are pregnant, 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.”

References
FDA approves weight-management drug Qsymia. FDA News Release. July 17, 2012.
Prescriptions for contraindicated category X drugs in pregnancy among women enrolled in TennCare. William O. Cooper, Gerald B. Hickson and Wayne A. Ray. ©Blackwell Publishing Ltd. Paediatric and Perinatal Epidemiology 2004, 18, 106–111. Posted on FDA.
Qsymia Medication Guide. ©2012, VIVUS, Inc.
QSYMIA (phentermine and topiramate) Extended-release Capsules [Category: anorectic and antiepileptic] VIVUS, Inc. RISK EVALUATION AND MITIGATION STRATEGY (REMS).
For further questions about cleft lip and cleft palate, contact The Cleft Lip and Palate Foundation of Smiles. Cleft lip and palate are two of the most common birth defects, which affect one in 600 children in the United States. The Foundation was formed by a  mother of twins born with cleft lip and palate. The Foundation offers positive support to parents of children with craniofacial differences by offering news, information on cleft palate teams, state by state resources, birth registry listings, and a support group where you can meet other families who are going through similar concerns, and where you can share and express useful information.