Phentermine has been available for a while, but one of its more serious side effects is convulsions, so this new drug appears on the surface to simply be a way to control this side effect.
Qsymia is being made by Vivus Inc., a relatively small biopharmaceutical company from Mountain View in California. They specialise in treatments for obesity, sleep disorders and sexual health. In July 2012 the U.S. Food and Drug Administration approved Qsymia.
Who Can Take Qsymia?
Qsymia is available on prescription only. It will only be prescribed to patients who have a BMI of over 30, or, if you have a weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol, it may be administered to patients with a BMI of over 27. Calculate your BMI here.
Conditions of Use
Vivus make it clear that this drug does not work in isolation. Patients need to follow a healthy lifestyle with increased exercise and a healthy, well-balanced and calorie-reduced diet when taking Qsymia. It is certainly not a magical cure for being overweight and it will not be legally available without a prescription.
Qsymia Safety Trials
Qsymia was tested on more than 3700 patients during the phase 3 trials. The trials found that patients taking Qsymia lost around 10% bodyfat during the trial period, compared to a weight loss of around 1.5% for those who were given a placebo.
Common Side Effects of Qsymia
The research by Vivus found that the “most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.”
Qsymia can cause fetal harm and absolutely must not be taken by women who are pregnant of planning for a family. It is advised that women take a pregnancy test before starting the medication and then receive monthly tests throughout the course. If a woman becomes pregnant while taking the medication the treatment must be stopped immediately.
Unknown Effects and Limitations of Use
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. Doctors are advised to monitor heart rate in all patients, especially those with cardiac or cerebrovascular disease.
Qsymia is in a capsule form that is taken once per day. The recommended daily dose is Qsymia 3.75 mg/23 mg (phentermine 3.75 mg/topiramate 23 mg extended-release) daily for 14 days; then increase to 7.5 mg/46 mg daily.
If weight loss is not experienced by a patient then the medication should be discontinued. Patients taking higher dosages need to be weaned off to prevent risk of seizure.
“Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose.” – FDA, July 2012.
Patients with renal or hepatic impairments should not exceed a 7.5 mg/46 mg dose.
Doctors are also advised to monitor patients for changes in personality and mental health, especially for depression and suicidal thoughts.
Mood and sleep disorders may occur, and if so, a reduction in dosage is recommended. Other mental problems include reduction in cognitive ability.
Qsymia must not be used in patients with glaucoma or hyperthyroidism.
Also, it is important to note that nothing is known about the effect of using Qsymia alongside other weight loss drugs, either prescribed or over-the-counter medications, alternative therapies or herbal remedies.
The only way to safely take this medicine is via a prescription with regular health checks.
Resources and Further Reading
FDA approves weight-management drug Qsymia. July 17, 2012. First seen on FDA.gov. Accessed 19th Sept 2012.
HIGHLIGHTS OF PRESCRIBING INFORMATION – These highlights do not include all the information needed to use QSYMIA™ safely and effectively. – Vivus.com. Accessed 19th Sept 2012.
VIVUS Announces Availability Of Once Daily Qsymia™ (Phentermine And Topiramate Extended-Release) Capsules CIV – Vivus.com. Accessed 19th Sept 2012.
“Limitations in anti-obesity drug development: the critical role of hunger-promoting neurons” by Marcelo O. Dietrich, Tamas L. Horvath. Nature Reviews Drug Discovery 11, 675-691 (September 2012) | doi:10.1038/nrd3739
Vivus have launched www.qsymia.com to promote the new drug.