Dec 17, 2010 M. Cord Ray
woman measuring waist - Luigi Diamanti
Contrave - Is the New Diet Pill Really Safe?
A new diet pill passed a first round toward becoming a household name. When will it come out and is it worth it?
In a country that is getting more and more obese, weight loss drugs could be a dream. Every weight loss drug should be a short term solution only. There has yet to be a weight loss drug without serious side effects – something that needs to be taken into account.
Contrave is no different - so like every drug you think about taking you will need to educate yourself on what it is, how it works, and do a serious weighing of the pros and cons.
Diet Pills or Uppers?
Diet pills are usually amphetamines (stimulants). They are made to speed up your whole body and therefore your metabolism. Most diet pills are taken off the market within five years of FDA approval. Almost all of them are taken off the market for the same reason, increased heart risks.
Contrave – What is it?
Contrave is a little bit different. Contrave is a combination of two medicines already on the market: the antidepressant bupropion and the anti-addiction drug naltrexone. Bupropion is the generic name for Welbutrin a well-known anti-depressant drug that effects the brain neurotransmitter dopamine.
Naltrexone is an “opioid receptor antagonist” which has long been used in the management of drug and alcohol dependence.
Contrave – Does it Work?
Well….sort of. In the clinical trials the groups taking Contrave only lost approximately 4% more weight than the control group.
The panel of FDA advisory experts voted in a 13-7 vote on December 8, 2010 to recommend that the FDA go ahead and approve the drug despite the fact that it did not meet all the requirements for passing a drug as a weight loss drug.
As a matter of fact, a weight loss drug needs to prove that it is at least 5% more effective than taking a placebo. While Contrave failed this standard, the FDA advisory panel recommended the drug anyway with the general thought that the 4.2% was close enough to 5 in this case.
Orexigen Therapeutics Inc. the drugs manufacturer did four clinical trials, each slightly over a year long, with between 500 and 2,000 subjects in each study.
The drug eeked by another qualification by meeting a “second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight” was how it was stated by the Associated Press.
So, if you were, say, 150 pounds, and this worked for you, you might lose seven and a half pounds over the course of a year or approximately two ounces a week. (Provided all other factors stayed the same.)
Contrave – How Does it Work?
Welbutrin effectively boosts dopamine. This is the neurotransmitter in your brain that makes you want to get up go. Feeling better can make people want to move more, be more social, take on more tasks. Dopamine itself gives the brain a feeling of “revving up”.
Naltrexone enters the brain and nervous system and blocks the receptor sites that drugs like heroin and alcohol have to attach to give us pleasure. It’s been used for over 20 years to treat addiction and should work for biological compulsive overeating cravings.
Contrave – Is it Safe?
Welbutrin has been around for over 20 years. It has a long list of side effects. The side effect that concerns us most here is increased racing heartbeat (tachycardia) approximately 11% and irregular heartbeat (arrhythmias) approximately 5%.
Naltrexone also has possible side effects, but taken by itself it doesn’t usually raise heart health questions.
FDA reported higher rates of side effects in Contrave because the two drugs were taken in combination -specifically high blood pressure, racing heartbeats, fitful sleep, and dizziness.
Dr. Sanjay Kaul, prominent cardiologist at the Cedars-Sinai Medical Center in NYC was one of the FDA doctors who voted no against Contrave. He made it clear that although the recommendation was given the doctor’s felt lukewarm about it for two reasons: the heart dangers were high and the weight loss results were low.
But Is It Safe?
The general answer is probably yes. If you monitor your own body and pay attention to the signs it is reasonably safe. It is more dangerous than Welbutrin alone. Dr. Kaul stressed more than once that the side effects of Welbutrin which can be severe are compounded in Contrave. Individual factors such as blood pressure, current medications, and family heart history that will determine whether or not it is safe for any particular individual.
When Can I Get It?
The medicine has NOT been approved by the FDA yet. The Federal Drug Administration often takes the advice of their panel of experts but has no obligation to do so. The doctors on the panel strongly urged for more testing and although the possibility is extremely slim, the FDA could ask that the testing be done before approval. However, the FDA vote is scheduled for January 31st or February 1st.
Will This Be The Pill That Helps Me Lose Weight?
We are a country of people who want an easy fix. When it comes to weight loss, it’s a trillion dollar industry where people struggle constantly and results are small.
This pill could be a real help for you if you are totally committed to change your lifestyle and want a little double boost to help you get started and keep you going. While clinical trials were less than stellar many hope that the anti-depressant factor may be the little push that proves to be the tipping point for some. If you feel you are one of those people who can do it with just a little extra get up and go then this may be just the solution you were hoping for.
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