The United States Food and Drug Administration has recently approved a new prescription diet drug called Qsymia. Qsymia contains a combination of phentermine (appetite suppressant) and topiramate (anticonvulsant) and is being used to treat obesity and related circumstances such as high blood pressure, sleep apnea, cholesterol and type 2 diabetes. It was developed in California and approved by the FDA by July of 2012. Due to the fact that this drug has just been approved there are few long term studies, but the recent studies that were conducted showed that in just over a year’s time participants lost an average of 37 lbs. There were 4,430 participants in the study and each had a body mass index (BMI) of 27 or greater. They were prescribed Qsymia in three different dosages, 15mg, 7.5mg and a low strength dose of 3.75mg. People who participated in the study also maintained a daily exercise routine and monitored their diets.
With any drug there were side effects experienced. Some of the most common included dry mouth and constipation. Some participants also experienced a tingling sensation in their finger and/or toes. Although none of the participants experienced any severe side effects, the FDA Advisory Committee generated a list of serious side effects to be considered before taking the drug. Some of these side effects include:
- Birth defects such as cleft palate or cleft lip
- Increased heart rate
- Suicidal thoughts
- Decrease in vision
- Unusual changes in mood
- Metabolic acidosis
- Loss of appetite
Some of the participants commented that they enjoyed taking Qsymia and that the drug suppressed their appetite. They also reported that they lost an average of 4lbs per month. Women who were taking Qsymia were encouraged to use a form of birth control to ensure they do not become pregnant due to the fact that an estimated 5 out of every 1000 pregnancies would result in their baby having a birth defect. Before the new diet pill is administered, patients of child bearing age will have to take a pregnancy test to ensure they are not pregnant, and it is recommended that they take a pregnancy test monthly when they are using qsymia. It was reported that 34 women did become pregnant during the study and none of them suffered a defect.
Makers of Qsymia, Vivus, have decided that the drug will not be available from doctors’ offices, but only by mail directly from the company. They fear that the drug can be misused and cause severe or fatal consequences.