FDA Approves Weight Loss Drugs ( Qsymia and Belviq ).. But Should We Use Them?

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You have heard it on the news and read about it in the paper...unfortunately the headlines are true...obesity has become an epidemic in America.

Latest reports estimate that over 60 million Americans are obese, and an even larger number are overweight.

So why should we care...

What is the problem?

The problem is obesity can kill us. Yes, that is right - obesity can kill us.

How, you ask?

Obesity can lead to diabetes, high cholesterol, elevated blood pressure and heart disease- all of which, if left untreated, can kill us.

All right, so how do we lose weight?

That is the big question, and two drug companies claim to have the answer.

Two new drugs have recently been approved by the FDA to fight obesity: Qsymia and Belviq.

These drugs are being touted as safe and effective ways to lose weight. Wow that is great news...

I can take one of those pills and lose weight while getting healthier - excellent!

Well, that is what we may be thinking but unfortunately that may not be the case. With all new drugs there is the inherent question of safety. They may be approved by the FDA, but that does not mean they are 100 % safe. The FDA's drug approval is based on data from clinical trials, clinical trials that have small patient populations and short durations. So what does that mean? It means a drug may have the potential to cause major health problems in greater patient populations over the course of a longer period of time. In other words, we don't know all the health risks of a drug until years after it has been introduced to the general population. Therefore, a drug may cause more harm than good in the long run.

For example, remember the drug Alli? This drug was hailed as a magic weight loss pill. It was proven to be safe and effective in clinical trials with no major side effects and was sold to the public as a solution to the obesity problem. Take Alli and you will safely lose all the weight you need. Great, right? Well, that was the case until the FDA slapped it with a warning concerning liver toxicity, and Alli proved to be not as effective as originally thought. Millions of Americans were shocked. Not only were they taking a drug that was not as effective as they hoped, they were also putting themselves at risk for long term liver damage. Alli was suppose to help us become healthier, not put our health at risk. Eventually the once hailed Alli faded away into obscurity and we let go of the notion of the magic weight loss pill. That is, until Qsymia and Belviq were FDA approved.

Suddenly, the magic weight loss pill is back- or is it?

Before we rush to take either Qsymia or Belviq we must first remember Alli. Like Qsymia and Belviq, it too was proven to be a safe and effective way to lose weight, the magic weight loss pill. But as it turned out, Alli was nothing of the sort.

Will Qsymia and Belviq share the same fate...?

Only time will tell.

Until then, we are left with the oldest, safest ways to lose weight...

diet and exercise.

About the Author

Marc Macera, PharmD, RPh's picture

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Comments

Dr Amr Ebied's picture

Hello Dr. Marc, It is really interesting to know about the two promising drugs that were promoted for weight loss. I must add to you that the major problem with weight loss drugs is that their users are dependent on those drugs. They see them as dream drugs, and part of that is really psychological. That's why obese patients use weight loss drugs for a lot of time, and also they become fascinated by the drugs' weak results as long as there are results in the first place. Another example of a drug that was once a beacon in the weight loss niche was the chemical "sibotramine" which was commercially distributed under the names of "Meridia" in the United States or "Reductil" in Europe. It suppressed appetite by a mechanism of action involving the brain, and it was said that if you combine that drug with diet and exercise, you would get the maximum benefit. I personally tried that drug, and its effect was amazing. It acted not only by making you not wanting to eat, but also it sort of sculpted your body into a slimmer toned look. Unfortunately it was lately discovered that with prolonged use of that drug, it caused some side effects on the heart and blood vessels, because it retained a lot of adrenaline, the major stress hormone, into the blood stream. So it was banned in Europe and the United States about 2 years ago because of a study showing that it produced prolonged QT changes in ECG in the hearts of recipients which would endanger the patient's life. Thanks for your valuable inputs, and looking forward to reading your articles more often. Dr. Amr Ebied

Amr

Ph. Bhagavan P S RPh's picture

Good blog Dr Mecera There are some dictum in pharmacology and therapeutics which have been very much capitalized and exploited by the drug manufacturers /importers, clinicians and regulatory authorities to take shelter in case of any issue arises with the use of the drug: 1. NO DRUG WILL CURE ANY DISEASE, IT ONLY HELPS THE BODY TO CURE ITSELF. 2. NO DRUG IS 100% SAFE 2. ANY UNTOWARD EVENT THAT HAPPENS IN ANY PATIENT WITH THE PRESCRIBED DRUG IS 'IDIOSYNCRASY'! THAT HAPPENS / OCCURS IN ONE IN MILLION OR TRILLION AND SO ON..... . So sorry we tried our best! 3. Every drug advised is only a 'try'. If it doesn't work one should try another drug and so on.... Patients on their part too try another doctor if they don't get relief with the treatment of first doctor. Added to these is popular saying in our pharmacy: 'What is tested is not used and what is used is not tested' - that means ours is a presumptive quality as ours is a destructive process of testing. A drug undergoes 4 phases of testing before getting approved for marketing: http://users.rcn.com/jkimball.ma.ultranet/BiologyPages/D/DrugTrials.html It is in the IV phase where lot of questionable activities could take place to ensure easy passage of approval, as no third party independent audit is mandatory. Here is one more link that has a relation the topic under discussion: http://www.moneylife.in/article/how-some-doctors-prescribe-these-days/27... With all these the certificate 'APPROVED' by whichever agency needs to be taken with a pinch of salt! But the moral of the story is: 'IT IS ALWAYS GOOD,EFFECTIVE AND SAFER TO GO IN FOR TIME TESTED DRUGS' Thank you >>

Bhagavan P.S. B Pharm

Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India

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