Hopefully, this drug will fail before taking off and making pharmaceutical companies BILLIONS of dollars, but just in case, I am writing this as a warning to those who are considering the drug for personal use. And if you know better, at least illustrate how important it is to research medications, supplements and herbs before you trust regulatory agencies that it is safe.
Contrary to statements made by Vivus, the manufacturer of QNEXA, about their concern on rising obesity rates, their only concern is the bottom line. The more they can cloud the truth and make this drug appear safe, the more money they get in the end. But if you succumb to their deception, the things you are likely to lose is your money and possibly your health, but not excess weight.
I base my position on this from a few different perspectives. First of all, my education. As much as one would like to believe that taking a pill will cure obesity, my two degrees in Nutrition have taught this much - obesity is multi-faceted problem, no one solution will fix it for everyone. Superseding the body’s natural regulation of hunger (which is the mechanism for QNEXA) will only go so far since there are numerous reasons of why we eat what we do, that go beyond these physiologic cues. Secondly, my experience. I work with patients who have epilepsy and many are on topiramate, one of the drugs used to make QNEXA. I’ve seen the side effects first hand and while it is successful at decreasing appetite and inducing weight loss it comes at a cost. I’ve also worked with adults and children to promote weight management. Everyone is different and success at achieving a healthy weight needs to be addressed as such. Finally, but most important, research. After reviewing the results of the trials and researching the side effects of the drugs used, I’ve concluded that the risks far outweigh the benefits.
QNEXA is described my Vivus as a drug intended to be used by overweight or obese candidates, based on a BMI >27 kg/m2 AND also must have co-morbidities associated with obesity such as high blood pressure, type-2 diabetes or abnormal cholesterol levels. While many Americans fall into the category of BMI >27, not all of them have these co-morbidities. The reverse is also true; many people have these conditions but are at a normal weight. According to a recent study published in the International Journal of Obesity, researchers found that 29% of people classified in the “normal” BMI range (<25), have heart disease risk factors similar to people who are obese. So, to say that QNEXA will make a significant difference in obesity risk factors is an overstatement, as its target will be only a portion of the obese population.
The pill itself is a combination of topiramate and phentermine, which are both FDA-approved medications. Topiramate is used for treatment of migraines and seizures and phentermine is a well-known drug for weight loss. The FDA originally denied approval of the QNEXA in 2010, stating that the risks associated with the drug were too high and long term effects were unknown, given that the trial was only 1 year. QNEXA extended the trial and gave the FDA advisory panel 2 years worth of data, which they have now surprisingly endorsed in a 20-2 vote. While the FDA does not have to take the advisory panel's recommendation, it is likely they will. So what changed the panel's mind?
The results of the Vivus trials averaged about a 10% weight loss in a year. For example, a 200 lb individual lost 20 lbs. Research shows that modest weight loss such as 5-10% of your body weight can reduce your risk of chronic disease. What is interesting is the sharpest drop in weight is seen in the first 4 to 8 weeks. The first 4 weeks subjects were being titrated onto the full dose, so they weren't actually receiving the full dose until week 4. Obviously, the subjects were geared up for the weight loss trial and were changing their diets and activity levels which resulted in weight loss. Even the placebo group experienced the same trend of weight loss initially, albeit not as great as the QNEXA group. The graphs of this can be seen on page 67 of the initial report from 2010 to the FDA (link is below). The weight loss continues to trend but begins to plateau after 6 months. Many people who change their lifestyle with the help of dietitians, personal trainers and organized programs such as Weight Watchers experience far greater results in much less time. Even if the weight loss was far greater, that completely avoids the issue of maintaining the weight loss after you stop taking the pill. As far as I could find, no trials have been done to see how long people were able to maintain the weight loss after they stopped taking QNEXA. The positive effects like decreased sleep apnea and lowered blood pressure can be explained by losing weight alone, the pill itself does not reverse those conditions. A magic bullet, QNEXA is not.
As for their risks, the manufacturers state side effects of faster heart rate and incidence of cleft lip or palate in children for women who become pregnant during the trial. They argue, that with education to health care providers to encourage birth control use and monthly pregnancy tests, this is controllable. Sounds reasonable. Except for the part where one of the many side effects of topiramate is that it makes birth control pills LESS effective! I’m curious to know how they justified that to the FDA.
Since we are talking about side-effects of topiramate and phentermine, let’s list them all out. Topiramate can cause decreased appetite and weight loss, but for some also increased appetite and weight gain! It can also lead to nausea, diarrhea, constipation, changes in how food tastes, indigestion, dry mouth, gingivitis, abdominal pain, decreased liver and kidney function, tremors, confusion, mood changes, nervousness, depression, back pain, apathy, fatigue, weakness, muscle pain, edema and menstrual changes. Phentermine can cause nausea, vomiting, diarrhea, constipation, can increase blood pressure and heart rate, tremors, dizziness, headache and insomnia. Phentermine can also be habit-forming and it is recommended to avoid alcohol and caffeine. It is also noted to be used with caution in those with diabetes as it can alter diabetes medications.
I lost my appetite just reading those side-effects.
To sum up, QNEXA claims to reduce risks associated with obesity, yet the two drugs used to make QNEXA are cautioned against being used in that very population! It is targeted to treat people with conditions that are contraindicated (diabetes and high blood pressure). The fact that this was completely disregarded by the FDA is frankly, frightening. Yes, obesity has its risks and treatment is important, but the QNEXA drug has the same risks, if not to an even higher degree. If this were the only option to help people improve their health, then I would understand accepting the risks, but there are other tried and true methods and QNEXA is not one of them. This is plain and simple all about money. And no amount of money is worth your life.
Zaneta M. Pronsky, MS, RD, LDN, FADA . Food Medication Interactions. 13th Edition, 2004.
Body mass index classification misses subjects with increased cardiometabolic risk factors related to elevated adiposity. International Journal of Obesity (2012) 36, 286–294; doi:10.1038/ijo.2011.100; published online 17 May 2011 http://www.nature.com/ijo/journal/v36/n2/abs/ijo2011100a.html