Qsymia and Pregnancy
Because women should not be trying to lose weight during pregnancy, Qsymia (phentermine and topiramate) should not be given to a pregnant woman. The U.S. Food and Drug Administration (FDA) has given this medication a pregnancy Category X rating, meaning it should be avoided during pregnancy because the risks clearly outweigh the benefits. Specifically, this drug may cause cleft palate, developmental problems, and other possible complications.
Qsymia® (phentermine and topiramate) is a prescription medication used to help people lose weight and maintain a healthy weight. It should not be used in pregnant women because it may harm an unborn child, and women who are pregnant should not be actively trying to lose weight.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Qsymia is classified as a pregnancy Category X medication.
Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Qsymia contains a combination of two medications: phentermine, a weight loss medicine, and topiramate (Topamax®), a seizure medicine that has appetite-suppressing actions. The combination of these medications caused a variety of problems when given to pregnant rats, including reduced fetal body weight, delayed growth and development, defects of the limbs and tail, and death in the newborn rats.
Perhaps more importantly, studies have shown that when taken in the first trimester of pregnancy, topiramate increases the risk of cleft lip and cleft palate in the fetus. In fact, women who take topiramate in early pregnancy are two to five times more likely to have a baby with an oral cleft defect.
Because these defects develop in early pregnancy, often before a woman even knows she is pregnant, it is recommended that women of childbearing potential use an effective form of birth control during Qsymia treatment. Also, women should have a negative pregnancy test before starting Qsymia, and every month while taking the medicine.
In addition, pregnant women are generally advised to gain weight during pregnancy. Even women who are overweight or obese when they become pregnant are advised not to lose weight during pregnancy. Therefore, a pregnant woman would gain no medical benefit from taking Qsymia.
If you are concerned about your weight during pregnancy, talk to your healthcare provider. He or she can give you an idea of how much weight you can safely gain, and help you develop a weight management plan that includes a healthy diet and exercise. You should not take Qsymia or any diet pills while you are pregnant.