 |
|
|
|
February 1st, 2011
12:41 PM ET
FDA rejects another obesity drugAnother weight-loss drug brought to the U.S. Food and Drug Administration for approval has been rejected. In the last 12 months, the FDA has nixed three new weight-loss drugs, lorcaserin because of possible links to cancer, Qnexa and now Contrave because of possible heart problems. In December, an advisory committee for the FDA first voted in favor of Contrave, a weight-loss drug that combines naltrexone and bupropion. That committee also voted 11 to 8 that the company, Orexigen should examine the drug's risk for major adverse cardiac events. But, the FDA does not always follow the advisory committee's suggestions. The agency rejected Contrave because of concerns about the cardiovascular safety after long-term use. In a letter, the FDA told Orexigen, the company which created Contrave that it must “conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile." Michael Narachi, Orexigen’s president and CEO, said in a press release that they were “surprised and extremely disappointed” and said: "We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the Contrave application." Contrave contains naltrexone, used to treat alcohol and cocaine addiction, and bupropion, an antidepressant, which also helps people quit smoking. Contrave would’ve been used by patients whose initial body mass index is greater than 30 (obese) or 27 and greater (overweight) with one or more health risk factors such as diabetes or hypertension. For an example, a man who is 5 feet and 10 inches and weighs 210 pounds would have a BMI of 30 and could be eligible to take the drug. In the clinical trials, subjects who took the drug had modest weight loss - at least 5 percent of their body weight. The subjects also had a small increase in blood pressure and pulse rate compared with the placebo group, and the “hypertension-related adverse events was significantly higher” in the drug group compared with the placebo subjects. This is the last of the weight-loss drugs reviewed by the FDA in 2010, which have all seen uphill battles. Last year, an advisory committee rejected Qnexa, citing concerns ranging from heart issues to psychiatric side effects. Another drug, lorcaserin was rejected after questions about the drug’s effectiveness and tumor development in rat studies. A previously approved drug, Meridia made by Abbott Laboratories was voluntarily withdrawn from the market in October due to an increased risk for heart attack and stroke.
Next entry »Get Some Sleep: Night terrors explained
|
  About this blog
Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
 |
|
|
|
Drugs are not the answer to solve obesity in America.
Why can't we Americans do something simple as eat less and exercise more? Oh, that's right because we are a lazy society looking for easy solutions, and not willing to work hard like the rest of the world, exactly why China and India will surpass USA as #1 and #2 world powers respectively.
Not only do unhealthy lifestyles and overweight/obesity lead to health conditions such as Type II diabetes and a range of different hypertension and heart disease, but now a diet pill that may potentially cause additional cardiac problems? I understand that maintaining a healthy lifestyle by exercise and monitoring diets is not always easy, but these pills are not the easy way out that consumers anticipate either. The recommended amount of physical activity, which does not necessarily mean vigorously running or exercising to the point of pain, is only 60 minutes/day. Rather than turning to unhealthy diet pills or other supposed easy-outs is not the way to get that body or weight you want! With a combination of physical activity and nutritional food choices, these unhealthy drugs can be eliminated!
Hopefully the FDA keeps rejecting these unnecessary obesity pills. This is a good move because it gives Americans fewer "easy way out" options
People stop it with the "exercise more and eat less". So many of us "FATTIES" do just that and the weight does not come off! I am one of them! Probably healther than most "thin" people I know. It's not just about the things thin people say "you should do". I'm just say'in. . . .
As a recovering "fattie" (not to goal yet, but getting there) I agree that pills are not the answer. There are folks who have conditions that make weight loss harder for them, I agree. But many people, myself included, just simply overate and didn't exercise. There is no "magic bullet". It was easy to put the weight on; it is HARD work to get it off. But it can be done. It is something I will work on for the rest of my life.
Congratulations to those of you who are able to exercise and eat a sensible diet and lose weight. But, these pills are not for this portion of the population. Medications are designed for people who have other issues that interfere with them losing weight that way. Maybe your weight gain is medication driven and hard to lose. Maybe you're disabled and can't do 60 minutes of aerobic activity, making weight loss more difficult. Maybe you have a heart condition and desperately need to lose weight, but hard activity isn't an option. Medications are for these people, who may be ill, obese, and can't just walk it off. Good medications on the market would save lives and money from difficult and painful operations. So, don't focus on what YOU can do, learn some EMPATHY!
I take naltrexone to control alcohol cravings thanks to an open minded addiction specialist md. I was not overweight at all but I still lost about 8 lbs from my starting weight of 135. It just makes you not hungry. No other effects at all. It blocks the high you get from consuming sugars and fats so you no longer think crave them. I have often wondered why more people can't be given this medication. Helps with alcohol cravings too.
A very beautiful and elaborate post.. tip on weight loss a.k.a tiponweightloss.info
I got my order in on time (last night, just a few hours before the dandliee), and I see my name is already on the credits page. According to the confirmation email I received, this will be shipped out within 1 week. So I guess I should expect to have this by the first March? 😉
Great – I should certainly pronounce, impressed with your website. I had no trouble navigating through all the tabs as well as related information ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Reasonably unusual. Is likely to appreciate it for those who add forums or anything, website theme . a tones way for your client to communicate. Excellent task..
http://www.zortilonrel.com/
https://truehealthreport.com/top-10-best-foods-keep-heart-healthy/
Respect to website author, some wonderful selective information.
http://www.vreyrolinomit.com/
https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/
Hello There. I found your blog using msn. This is a really well written article.I’ll be sure to bookmark it and come back to read more of your useful info. Thanks for the post.I will definitely return.
https://m.chork.net/watch?vid=b93a53d08
You have mentioned very interesting details! ps decent website.
https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/
What a great post. Thank you for sharing this! I'm going to send it to all my friends.
https://youtu.be/WPdYnTVKOVg
What a great post. Thank you for sharing this! I'm going to send it to all my friends.
https://youtu.be/WPdYnTVKOVg
Thank you for the good writeup. It in fact was a amusement account it. Look advanced to more added agreeable from you! However, how could we communicate?
https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/
https://bit.ly/3j5JFYH
Hello. splendid job. I did not expect this. This is a fantastic story. Thanks!
https://europa-road.eu/hu/tengeri-szallitmanyozas.php
Some truly interesting details you have written.Helped me a lot, just what I was searching for : D.
http://www.dumpawaste.co.uk
This was a great post. Thank you for sharing! https://cranberrytownshiplawnservice.tumblr.com/
https://cranberrytownshiplawnservice.tumblr.com/
Hey there. I found your web site via Google whilst looking for a comparable topic, your website came up. It seems to be good. I have bookmarked it in my google bookmarks to come back then.
https://www.orlandoweekly.com/orlando/christinis-ristorante-italiano/Location?oid=2292646
3gfp9 ma6bl 1two