Tuesday, April 9, 2013

Weight Loss Drugs Have Dubious Approval

July 18 was a red letter day for Qsymia, a new drug that just received FDA approval for weight loss. There were press releases and newscasts about the event.

As the television news moved through their analysis and shared their tests of the drug, a certain level of misgivings about the product arose in my mind. Certain concerns were not being addressed.

  • How effective is this drug?
  • What are the side effects?
  • Are there contraindications for people with heart and lung conditions?
  • Is it safe to take this drug without supervision of a doctor?

My first choice for investigating this drug with high approval from the FDA was an July 18 article from Consumer Reports. After reading their negative review, I went to my next choice for information, the FDA announce of its approval.

Consumer Reports answered all of my questions. How was that possible when the broadcast news sidestepped those issues? It was even more important, then, to see what the FDA reported with regard to use of the drug. There was disclosure. Why the drug was given approval in the first place is a mystery.

According to either reports, the effectiveness is limited. The trials were conducted over a year's amount of time and with a control group as well as the group using the drug. The study group, according to Consumer Reports, fared not significantly better than the control group, although the FDA claims the study group lost approximately 6.7% and 8.9% (normal dosage and maximum dosage) more than those who consumed the placebo. Both groups used a calorie controlled diet coupled with exercise.

It was interesting to note that in some cases Qsymia yielded no effects after a 12-week course of treatment. In those instances, the dose was increased. Some weight loss was achieved after the change. But what the consequences were in regard to the known, reported risks was not shared.

As to side effects, Consumer Reports shares that ". . . it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke." The FDA discloses that, "The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth."

There are definitely contraindications for people with heart and lung diseases. In fact, it poses a high risk of heart attack or stroke. Women who are or could become pregnant are also advised not to take the drug because of the risks to the unborn child, namely, increased risk of the child being born with a cleft lip or palate.

Yes, there are additional risks that are reported by Consumer Reports. Those include an increase in the risk of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide (ideation).

The drug can only be dispensed through Risk Evaluation and Mitigation Strategy, or REMS, where doctors and pharmacies have been informed about the studies and the results of them. So the answer to my last concern is, no, it should definitely not be taken without supervision of a doctor. Because of the risks involved, it's understandable and not an advertising gimmick designed to frighten the public. As a consumer, I have no problem drawing my own conclusions about whether this could be used as an over the counter product. But it seemed prudent to allow the experts to speak. Both Consumer Report and the FDA strongly recommend that this drug only be used under doctor supervision.


Lipozene came to my attention when it was advertised on a late night / early morning commercial on August 4. For a mere $30, it is possible to get a two-month supply of the pills that will melt away the fat according to the ad. That representation was guaranteed with a money back offer if the customer was not satisfied.
The first question is whether it is safe for those who suffer from other health conditions, particularly heart or lung disease, not to mention adverse reaction to whatever ingredients the pills contain. The second question is how it compares to Qsymia both in quality and effectiveness.

A quick search engine query brought forth a lot of information about Lipozene. It would behoove the prudent (and not) to investigate before leaping. As it turned out, Lipozene is proven to be a scam. Our About Guide, Millicent Odunze, M.D., does a wonderful job of parsing out the ad's claims.

The most significant thing that comes to my mind as I view any of the weight loss advertisement and health news installments is "how much weight and over what period of time". Dr. Odunze says the claims are that you can lose a little less than 4 pounds of body fat within two months. Dr. Odunze is quick to point out that body fat and body weight are two different things. One pound of body fat, she suggests, is the equivalent of 1/3 of a pound of body weight. It's important to understand that on a weight loss diet of moderate calories that includes exercise and so on should amount to a maximum of three pounds of body weight loss in approximately one week. The average is approximately 5 to 10 pounds in one month. Yes, that was body weight, not fat.

In addition to bashing nearly everything in Lipozene's ad, plastic surgeon Odunze advises us of what it would take to lose approximately four pounds in two months:
For those who can't bear to exercise and want to do the least amount of work possible, consider this. It takes a 3500 calorie deficit to lose one pound. To lose the four pounds in eight weeks that LIPOZENE boasts about, you need to create a 14,000 calorie deficit total. You can do this by eating just 230 less per day for those 8 weeks. That's one candy bar!

We all can do that!

But this notion of using Lipozene should be put off by the words of just one doctor. Let us investigate some other independent sources to see what they have to say. The entry "Glucomannan" in Wikipedia tells us about Lipozene. It is a dietary fiber supplement used to cleanse the colon "sold as nutritional supplements for constipation, obesity, high cholesterol, acne vulgaris and type 2 diabetes" and are "made from the ground corm of the konjac plant." Another name for it is the broom of the intestine. It's a cleanser.

There are findings that Lipozene has positive effects on cholesterol that impacts Diabetes Type 2 and obesity. The chemical reactions and findings regarding the supplement are spelled out in the Wikipedia listing. The health risks from this fiber supplement are if the water regimen is not followed, the risk of choking and holding the fiber are posed because it cannot be flushed from the body's system. It's more a constipation remedy than a weight loss product.

Linda Bell writes the "Thin Report" and informs us that there are no overtly negative risks or dangers from use of this product. The biggest danger she points out is doing business with the company that markets the product. There doesn't seem to be any correlating information, let alone effects, relating to Qsymia. It doesn't appear Lipozene has any negative effects related to heart or lung diseases.

What to Do in Regard to Either or Both

After looking at the risks, benefits, and consequences of using either of these medical drugs, it appears ill advised to use either for the sake of weight loss.

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