Qsymia, the new blend of weight loss drug containing phentermine and topiramate

What is Qsymia?

does-qsymia-work-img1Qsymia is one of only two weight-loss pills which have been approved by the FDA, Food and Drug Administration, since 1999. Coincidentally, both pills have been approved in the last month after increasing pressure on the regulators by health professionals to try and tackle the growing obesity problem, which stands at 35% of adults in the US.

Qsymia is a federally controlled substance, manufactured by Vivus Inc, which is estimated to be available in the last quarter of 2012. Initially it will be available only through mail order from ‘certified pharmacies,’ and not through your physician.

The guidelines under which the FDA have approved Qsymia is that it is prescribed for chronic weight management in the obese in only two situations; for those with a BMI of 30kg/m2 or anyone with a BMI of 27kg/m2 and one weight related medical condition, such as high blood pressure, type 2 diabetes or high cholesterol.

Dr Barbara Troupin, Vivus’ Vice President of scientific communications and risk management told CNN “There will not be dispensing from doctors’ offices…seeing that issue and what has happened in fad and diet drugs in the past, that is not a path that we’re going to be taking.”

Clearly referring to the 1990s fen-phen phenomenon where physicians literally opened ‘pill mills,’ prescribing the phentermine based drug even to those with minor weight issues. The strict control over the dispensation of Qsymia is because it contains phentermine and topiramate, both incredibly potent drugs which can have serious, if not fatal side effects.

How does it Work?

Qsymia contains a blend of phentermine and topiramate in extended release capsules. Phentermine is similar in chemical structure to amphetamine and affects the central nervous system by mimicking the effects of adrenalin to increase heart rate and suppress appetite.

Phentermine has long been linked to effective weight loss in the obese, but only as a last resort when all other options have failed due to the serious potential side effects. Interestingly, phentermine is joined by topiramate in Qsymia, which is an anti-convulsant drug, used to treat epilepsy.

Topiramate There have been some indications through clinical studies that topiramate also aids weight loss in two respects; firstly by effecting blood glucose and insulin secretion so the body uses fat stores as a primary source of fuel instead of food, a process known as ketosis; and secondly its successful treatment of bulimia nervosa indicates that it limits binge eating, suppressing cravings and appetite levels.

Qsymia itself has been subject to a number of clinical trials before receiving FDA approval. Out of 4430 people who trialled the drug, one half lost 10% of their body weight, and on average they lost between 227 – 204 pounds.

Vivus specify that the effects on the individual should be strictly monitored, and the healthcare provider should make the decision to either stop or increase the dose if a certain weight target hasn’t been reached in the first 12 weeks of use. If the dose is increased and a certain target achieved in the subsequent 12 weeks, then it is up to the discretion of the healthcare provider to then reduce the dose again.

Potential Qsymia side effects

The potential side effects are extensive, including depression, mood swings, suicidal thoughts, increased heart rate, eye problems, glaucoma, insomnia, constipation, increase in metabolic acidosis (acid in bloodstream which can lead to osteoporosis), impaired thinking, concentration and memory loss.

The active ingredients in Qsymia are habit forming and Vivus stipulate the drug should not be stopped immediately due to the high risk of side effects from withdrawal.

People with glaucoma, overactive thyroid, or those taking MAOI anti-depressants should also avoid this drug and Vivus advise that you should not drive or operate heavy machinery due to its effect on reasoning and concentration.

Is Qsymia worth trying?

There is no doubt that Qsymia will be a very powerful aid in the war on obesity, but it does come at a price. Vivus have not established if Qsymia will increase the risk of heart problems and stroke, or  whether Qsymia is safe to take with other weight loss products, even herbal supplements.

It is clear that Qsymia is only suitable for a limited number of people, and where the risks of Qsymia are outweighed by the advantages. In extreme cases where there is no other alternative to treating the morbidly obese then Qsymia will offer a life line.

Vivus do recommend that Qsymia be taken in combination with a healthy diet and exercise, and after the initial weight loss Qsymia could offer a realistic way to maintain a healthy weight and lifestyle where none existed before.