Sharon Vining: New Weight Loss Drug

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Diet Pill

By: Sharon R. Vining

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I get excited every time I hear about a new weight loss drug.  I think to myself, “Is this IT?  So far the answer has always been no.  But I remain hopeful.

Qsymia is the first prescription weight loss drug to get the FDA’s approval in 13 years.  Questions:  what is it, does it work, how well does it work, what are the risks and how much does it cost?

Qsymia is a combination of two drugs phentermine and topiramate.  Phentermine is an appetite suppressant.  In case it looks familiar, it was the “phen” in the weight loss combination drug fen-phen.  The FDA it withdrawn from the market after the “fen” fenfluramine was reported to cause heart valve damage and lung problems.

Topiramate is an anti-seizure drug which is thought to suppress appetite and give you the full feeling.

How well does it work?

Research done by the manufacturer Vivus, in the first study, the placebo group had a 2.1% weight loss and the Qsymia 3.75mg/23mg lost 6.7% and the Qsymia 15/92mg had a 14.4% weight loss over a 56 week period.

In the second study, the placebo group had a 1.6% weight loss.  The Qxymia 7.5mg/46mg had an average weight loss of 9.6% while the Qxymia 15mg/92mg had a 12.4% weight loss over a 56 week period.

Therefore, a person taking Qxymia 15mg/92mg, the maximum dose, over a period of 56 weeks can expect to have about a 13% weight loss.  This means a 200lb person can expect to lose 26 pounds in 56 weeks.  This equals 2 pounds a month or ½ pound a week.

What is the Cost?

Currently Qsymia is not covered by most insurance.  According to Michael Miller, chief commercial officer at Vivus the average cost is $160 for a one-month supply.

This means that a 56 week supply would cost $2080.  Put another way, using Vivus’s research data, it will cost $80 for every pound lost.

What are the Risks of taking Qsymia

 I went to the manufactures website.  A large portion of the website is dedicated to safety information (20 paragraphs).  Qsymia is a teratogenic which means it can cause harm to the fetus.  A fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate).  “ Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effect contraception consistently during Qsymia therapy.”

Briefly some of the side effects are: heart problems, mood disorders, and increases risk of suicidal thoughts, glaucoma, and cognitive dysfunction, an increase in creatinine (which means kidney dysfunction), hypoglycemia, electrolyte problems and adduction.

It also interferes with various other drugs so if you really want to try this drug check with your doctor and be clear what drugs can be taken with this drug.

Problems I find with this drug

  1. Being a teratogenic is my #1 problem.  Accidents happen.  I would hate to see a child born with a cleft palate problem because Mom accidently got pregnant while on the drug.
  2. There are alot side effects with this drug which make me uncomfortable.
  3. The cost.  At about $80 a pound, I don’t think so.  To save on cost, these two drugs can be purchased separately then taken together and the same weight loss can be achieved at probably a much lower cost.
  4. A flaw in the research study was failure to distinguish what kind of weight was lost.  Was this weight loss fat? Muscle? Water?  A better study would have monitored percentage of fat and muscle loss.
  5. My final flaw with this study.  The manufacture recommends changes in diet and exercise.  They suggested a decrease in caloric intake of 500 calories a day.  500x7= 3500 calories.  3500 calories = 1 pound of fat.  By decreasing caloric intake 500 calories a day a person can lose 1 pound a week, or in the case of this study, 56 pounds in 56 weeks.  By introducing these variables of diet and exercise, Vivus invalidated their own research study.

Conclusion – this is not the miracle drug we are all looking for.

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