CONTRAVE (WELLBUTRIN) FOR WEIGHT LOSS?
As if the ravages of the serotonergic diet drugs Phen Fen and Redux in the mid 90’s did not generate enough pain and suffering, the FDA next approved a drug almost identical to Redux that had just been pulled from the market for the heart damage, but more for the brain damage it caused. The new drug Merida was finally pulled from the market in 2010 I believe. And since then the FDA has “blessed” us with three new diet drugs since 2012. Qsymia (phentermine and topiramate) and Belviq (lorcaserin) were both approved that year and both of them are serotonergic drugs with similar side effect profile of the SSRI antidepressants including Serotonin Syndrome and suicide. Then the latest weight loss drug was approved on September 10, 2014.
The brand name of the new drug is Contrave. But it is not actually a new drug, as most are not any more, but it is a combination of two presently approved drugs, the antidepressant Wellbutrin and Naltrexone, an anti-addiction drug.
With this drug those in the clinical trials lost an amazing 2% – 4% more than those on placebo! Over a six month period they lost 25 pounds.
Wow! Now doesn’t that sound effective?! Sure makes me want to try it! How about you? Funny that going to a raw Vegan diet and being out on a farm this summer I lost 15 pounds in four months this summer. No wonder we find the following statement in the following article about the new “diet drug”….
A most classic statement: “Is the new drug meant to be used in combination with diet and exercise? …. Absolutely, doctors agree. “If you try to use it in isolation, that patient is not going to have success,” says Bipan Chand, MD.”
So there is no cutting corners with the drug, you cannot just take the drug and lose weight. You have to do diet and exercise with it for it to work. So … what really produces the weight loss? Obviously it is the diet and exercise!
Somehow I have trouble believing there is much of anything this drug does to help. Certainly seems that it would not be worth taking the chance with Wellbutrin as part of the combination that makes up this drug. Wellbutrin is the antidepressant that Donna Fairchild, the City Counselwoman who was running for Mayor in Mesquite, NV, took a couple of years ago as a stop smoking aid. Then in abrupt withdrawal from the drug she shot her husband and herself. Donna and her husband were both retired Denver police officers.
For many other similar examples of what can happen on Wellbutrin I would suggest you go to our database of cases at www.ssristories.net and click on the option of which drug the person was on and read all of the Wellbutrin cases there. That will give you some idea of whether you think a 2% to 4% weight loss is worth taking such a chance. Since I got straight A’s in math, you will certainly not see me standing in line for a prescription for this drug! (Or any other, for that matter with all I know now about Pharma and their practices!)
And just for fun I suggest you go to http://www.belviq.com/ and read the Important Safety Information on Belviq. I assure you it will surprise you what all you are going to find there. Clearly none of these drugs can be taken safely with an antidepressant which causes the weight gain for which you might consider a weight loss medication!
Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & http://ssristories.drugawareness.org
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”
WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships for the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan.
WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!
ORIGINAL ARTICLE:By Kathleen Doheny
WebMD Health News Reviewed by Arefa Cassoobhoy, MD, MPH
Sept. 11, 2014 — The FDA’s approval on Wednesday of a new prescription weight-loss pill offers yet another option for the more than one-third of American adults who are obese. Called Contrave, the new drug is the third prescription weight-loss drug to be approved by the FDA since 2012. It’s also approved for those not obese but overweight with risk factors such as high blood pressure, high cholesterol, or diabetes.
Contrave joins Qsymia (phentermine and topiramate) and Belviq (lorcaserin). Both were approved in 2012.
Contrave combines two drugs already on the market: bupropion (Wellbutrin), an antidepressant, and naltrexone, an anti-addiction drug. Because it contains bupropion, the new drug will have a boxed warning to alert doctors and patients to the increased risk of suicidal thoughts that are linked with antidepressants.
Weight loss experts say all three drugs work in similar ways, but they welcome Contrave as yet another option, especially since not all weight loss drugs work the same for everyone.
The FDA approval came after the agency looked at new information it requested from the drug’s maker in 2011 to be sure the drug was safe for the heart. Even so, the approval came with a requirement to do another study about the drug’s effect on the heart.
Here’s what else to know about the new drug.
How does Contrave work?
”It takes away hunger and the cravings for food,” says John Foreyt, PhD, professor of medicine and director of the Behavioral Medicine Research Center at Baylor College of Medicine, Houston. He was a researcher on a clinical trial studying Contrave. He does not have financial ties to Orexigen, the drug’s maker, or to Takeda Pharmaceuticals, which plans to market the new drug.
How the combination works for weight loss is not entirely understood, even by experts. The bupropion helps lessen appetite, says William Troy Donahoo, MD, an endocrinologist and weight loss specialist at Kaiser Permanente, Denver. The naltrexone, he says, probably works by blocking certain receptors in the brain and curbing cravings.
Who is eligible to take it?
The drug, a daily pill, is approved for use in adults with a body mass index or BMI of 30 (obese), or a BMI of 27 (overweight) with conditions that raise heart and stroke risks, such as high blood pressure, cholesterol, or type 2 diabetes.
A 5-foot-9-inch person who weighs 183 pounds has a BMI of 27. At 203 pounds, his or her BMI is 30.
The drug should not be given to anyone with a seizure disorder, pregnant women or those trying to get pregnant, or anyone with an eating disorder, among others, according to the FDA.
Is the new drug meant to be used in combination with diet and exercise?
Absolutely, doctors agree. “If you try to use it in isolation, that patient is not going to have success,” says Bipan Chand, MD. He’s the director of the Loyola University Medical Center’s Center for Metabolic Surgery and Bariatric Care.
The ideal patient, Chand says, is one who will look at their diet, make healthier choices, and get regular exercise, along with taking the medicine.
The drug will help with controlling how much someone eats, Foreyt agrees, ”but we still have to watch what we eat and exercise regularly.”
In clinical trials that included obese and overweight men and women, everyone received instructions on eating a reduced-calorie diet and getting regular exercise.
How much weight do people on this drug lose?
The amount varies, but on average, people lose 5% to 10% of their starting weight, according to clinical trials and experts.
In one 56-week study looking at Contrave combined with health habit changes, those on the drug lost more than 9% of their starting weight, while those on placebo lost just 5%.
So a 200-pound person losing 10% would end up at 180 pounds, perhaps moving from the obese to the overweight range, or the overweight to the healthy weight range.
In clinical trials that studied more than 4,500 people, the drug helped people keep off weight for up to a year, the length of the studies, according to Orexigen. On average, those who took Contrave for 6 months and combined it with a weight-management program lost 25 pounds, the company says in a statement. Those who were on placebo and the weight-management program averaged a 17-pound loss.
According to the FDA, people without diabetes who were in one of the clinical trials and took Contrave had an average weight loss, at the 1-year mark, of 4.1% over those who took the placebo pill.
In another study of those with type 2 diabetes, those on the drug lost 2% more than those on placebo.
In approving Contrave, the FDA says that those using it at the maintenance dose ”should be evaluated after 12 weeks to determine if the treatment is working.” If the weight loss at that point is not at least 5% of starting weight, the drug should be stopped, according to the FDA, as it is not likely to work adequately and long-term for the patient.
If the drug is working, the label has limit on how long it can be taken.
The results seen in studies of the drug aren’t always the same once the drug is on the market, Donahoo says. Once on the market, he says, the medicine may give better results than in clinical trials.
Part of the reason, he says, may be that doctors familiar with their patients can pick the weight loss drug they think may be most likely to work for a specific patient.
What are the side effects of the new drug?
In the clinical trials of Contrave, nausea was most common, reported by 34% of people, Foreyt says. Other complaints were headache, constipation, dizziness, vomiting, insomnia, dry mouth, and diarrhea, the FDA says.
The FDA rejected the request for approval of Contrave in 2011, requesting more information about the safety of the drug for the heart. In response, Orexigen launched the Contrave Light Study, including nearly 9,000 patients, to rule out excess heart and stroke risks in those taking the drug.
The interim results of the study, announced in late 2013, met the FDA goals, according to the company.
The FDA approval includes requirements for post-marketing research, including a heart outcomes trial to look at any heart and stroke risks. The company must also look at the potential for interactions between Contrave and other drugs, evaluate the best dose for patients with liver or kidney problems, look at the safety of the drug in children, and do other research.
How does Contrave compare to the other two recently approved weight-loss drugs?
No head-to-head comparison has been made of all three drugs — Contrave, Belviq and Qsymia — but experts can talk in general about how the drugs are alike and different.
“All affect one’s desire to eat,” Chand says of the three. In contrast, other weight loss drugs, such as orlistat (Alli, Xenical) work by reducing the digestion and absorption of fat in food.
“There is no way to predict who will respond and will not” to the various drugs, Chand says. “It is trial and error.”
What will Contrave cost?
Company spokespeople declined to estimate. But other experts expect it to be priced competitively with the other two prescription weight-loss drugs.
Both cost about $6 or $7 a day, or about $180 to $210 a month.
Insurance coverage for Qsymia and Belviq varies by plan.
Takeda, which will distribute Contrave, expects the drug to be available in the fall, says Denise Powell, a spokeswoman for Orexigen.