While a few extra pounds may not seem like a big deal, they can increase your chances of having high blood pressure and high blood sugar. These conditions may lead to serious health problems, including heart disease, stroke, type 2 diabetes, and certain cancers.
FDA recommends you evaluate weight loss after 12 weeks of treatment. If you have not lost at least 3% of your body weight on Qsymia 7.5mg/46mg, stop Qsymia or increase dose. If you have not lost at least 5% of your body weight after 12 weeks on Qsymia 15mg/92mg, stop Qsymia because it is unlikely to work.
Adults who are overweight (Body Mass Index (BMI) of 27 to 29.9) with a weight-related problem (high blood pressure, high cholesterol, or heart disease) or are obese (BMI of 30 or higher)
Medium track record means that new‚ unexpected side effects are possible. Qsymia was approved by FDA in 2012 based on studies where about 2,300 people took approved doses of the drug for 12 months. As with all new drugs, rare but serious side effects may emerge after the drug is on the market when larger numbers of people - with other conditions and on other medications - have used the drug.
FDA is requiring the company to conduct studies to answer open questions about possible increased chance of heart attacks and strokes or kidney damage from the drug
Including topiramate and phentermine (or other sympathomimetic amines)
Qsymia passes into breast milk and can harm your baby
Not tested in children younger than 18
Qsymia has not been tested in this situation
Do not take: Controlled human studies show Qsymia harms baby and potential benefits do not outweigh potential harms (FDA Category X)
Do not breastfeed while taking Qsymia - either stop breastfeeding or stop Qsymia