Qnexa, the next weight loss 'miracle'?

I was reading in the New York Times today about a new weight loss pill that has not hit the market yet called Qnexa®. The drug was invented by Dr. Thomas Najarian, who opened a weight loss clinic in California in 2001.

Here's what we know so far about Qnexa®:

It was rejected by the FDA in 2010. FDA declined to approve Qnexa® citing the risks of birth defects (specifically cleft palate) and cardiovascular problems.

  • The side effects noted are altered tastes, constipation, dizziness, dry mouth, headache, depression, anxiety, sleep disorders, attention, memory, language and other cognitive disorders, metabolic acidosis, increased heart rate, possible renal stones, and teratogenicity***.
  • It has been shown to reduce weight by significant amounts by it's participants while taking the drug, but the participants gain the weight back after ceasing treatment.
  • If approved by the FDA, it will be the first diet pill in 13 years to be approved by the FDA.
  • Qnexa® consists of two drugs phentermine (a stimulant-also known as Adipex®) and Topiramate (an anticonvulsant-also known as Topamax®). These both seem to work well together to quell appetite. These drugs are effective alone by themselves to stimulate weight loss, but when put together in specific amount combos, weight-loss far exceeds any weight loss than one would find by taking either product alone. Topiramate has not been tested or approved as a weight loss drug, but those who have used it have had weight-loss as a side effect of it.
  • While the Phentermine supresses appetite quickly the controlled release of Topiramate decreases appetite and increases satiety throughout the day. So when the hunger comes back after the initial release of Phentermine suppressant, the Topiramate kicks in.
  • The Topiramate has blood pressure lowering effects and has resulted in drops of systolic blood pressure (the upper number in a blood pressure reading) at one year. The drug has allowed participants to reduce their blood pressure medication.
  • Qnexa is prescribed once daily. Upon approval, candidates may include people with BMI** of 27 to 30. A BMI of 25 or over is considered overweight. A BMI of 30 or over is considered obese.
  • One of the requirements for the FDA for the drug to be considered as an obesity fighting drug is it must have at least a third of it's test patients lose 5% or more body weight, and Qnexa® has passed this test easily.
  • Even though the drug has not yet been approved, the two drugs Phentermine and Topiramate taken together in specific amounts discovered by Vivus Inc*, are essentially the same thing and are currently being prescribed together by obesity doctors.

My honest opinion (as you could probably guess)? Just exercise and eat a diet that is as close to nature as possible. This just seems really silly and lots of hoopla. Your body is designed to move and eat things that are as close to nature as possible. Don't let someone else deem what is 'safe' for you. Most parameters set by organizations of whether things you ingest or are 'safe' for you is whether or not kills you. You are given an appetite for a reason. Why is it that advertisers are always trying to suppress it? Makes no sense.....

*Vivus Inc is the company from California that has been experimenting with this 'affective combination' for several years and have released formulations of the drug to produce the trial diet pill.

**A BMI uses height and weight to guestimate body fat levels.

***teratogenicity - Teratogenicity is the ability to cause developmental anomalies in a fetus. The greek root meaning is "monster", which is a reference to the fact that some developmental abnormalities were viewed as monstrosities.

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