Weight loss drugs fda snopes,how to lose weight with amla juice,eating menu for weight loss yoga - 2016 Feature

29.11.2014
A new weight-loss pill that many doctors consider the most effective of a new generation of anti-obesity drugs got the approval of the Food and Drug Administration on Tuesday. The pill, called Qsymia, was approved for patients who are overweight or obese and also have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
The drug offers hope for those who have failed to lose weight in other ways, but its path to approval also underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective. The drug's maker, Vivus Inc., said it plans to bring the drug to market in the fourth quarter of this year. In testing, the drug made led patients to lose more weight than two other weight-loss pills recently review by the FDA. Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss.
Researchers say the innovation of Qsymia lies in targeting more than one of the brain signals that drive people to overeat.
Qsymia is the second weight-loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June. The FDA's approvals of Qsymia and Belviq suggest a new willingness to make weight-loss medications available, even in the face of lingering safety issues. The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women.
The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known. Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout. Everyone seems to have questions like do weight loss drugs & supplements work, are they safe, and if so, how do they work. Dietary Supplements: These are not approved by the FDA and hence are not tested in clinical trials.
Suppressing Appetite: Most weight loss drugs work by suppressing the appetite and thereby reducing food intake. An example is Meridia (sibutramine), which is the only drug approved by FDA for long-term use.
Altering food absorption: These reduce weight by preventing the absorption and digestion of fat in foods. Alli (Orlistat) which prevents fat absorption is the only over- the-counter drug approved by the FDA to treat obesity .
Increasing Energy expenditure: These drugs (called thermogenics) help by increasing your metabolism or energy expenditure.
Weight loss drugs work best when complimented with lifestyle modifications like diet and exercise. Weight loss drugs cannot cure weight problems; get off the drug, and you will gain all the weight back.
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The drug is actually a combination of two older drugs long known to help with weight loss: phentermine and topirimate. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satisfied after eating.


The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by the FDA. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased risks for heart attack and stroke.
The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug.
Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
However, FDA regulators ordered the company to change the name to avoid potential confusion with similar-sounding drugs. But some of the popular ingredients in weight loss products have been banned by the FDA because of harmful side effects. There are many different weight loss supplements and medications that can help with this goal, but not everyone has access to them. A doctor can be a powerful ally in your quest to lose weight, and discussing any supplements for losing weight you’re considering with a physician can guide you towards the most effective weight-loss plan. These weight loss supplements (also known as nutraceuticals) have developed a strong following among people who want to lose weight due to their high standards of quality and proven track records for improved weight loss. It’s true that alternatives Phentermine pills for weight reduction are, generally speaking, less powerful than the prescription drug.
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The company said patients on the strongest formulation tested lost nearly 11 percent of their weight. But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.
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This is why finding effective Phentermine alternatives is so appealing to people who want to lose weight. So, I needed, really did need to lose the weight." So Wade volunteered to help test Qnexa, an experimental drug pending before the Food and Drug Administration.
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Qnexa's rejection came amid a flurry of failed attempts by drug companies to win approvals of new weight-loss drugs. Even though obesity is at epidemic levels, the FDA hasn't approved any new weight-loss medicines since 1999. The FDA has been especially tough on weight-loss drugs because of previous problems with those drugs, such as the diet drug cocktail fen-phen. You recall the fen-phen episode where a significant number of people got heart-valve defects," says Janet Woodcock, a top FDA official.
Woodcock argues that the agency has to be extra-careful with weight-loss drugs, because chances are it won't just be obese people taking them.
What might look like a rare problem now could turn into another public health disaster, she says. They say the FDA wrongly still tends to view weight-loss drugs as diet pills — something frivolous and used primarily for cosmetic purposes. We're talking about medications to help those who are struggling with the health impact of obesity," Nadglowski says. So Nadglowski and others are pushing the FDA to take into consideration whether the risks of new drugs may be outweighed by their benefits beyond weight loss, such as reducing the risk for heart disease, diabetes and other complications of obesity. Barbara Troupin of Vivus, the company that is developing Qnexa, says the drug appears to do a lot more than just help people lose weight. Vivus hopes the FDA will agree that those benefits will outweigh some of the risks, including the concerns about birth defects.
The company is submitting new data it says show that the risk is lower than had been feared. Some see Qnexa as a test of the FDA trying to recalibrate how it weighs risks and benefits for weight-loss drugs. Transcript RENEE MONTAGNE, HOST: The Food and Drug Administration is taking another look at a drug that could help people lose weight.
As NPR's Rob Stein reports, the meeting next week by an FDA panel to reconsider that drug comes as the agency is rethinking how it evaluates weight-loss drugs.
WADE: And I had problems with my feet and ankles, and they were saying that I was borderline diabetic and, you know, just stuff like that. STEIN: Over the next year, Qnexa helped Wade slowly drop about 40 pounds, and keep it off for another year. It was worried about the drug's side effects, especially possible heart problems and birth defects. Even though obesity is at epidemic levels, the FDA hasn't approved any new weight-loss drugs since 1999. CHRISTINE FERGUSON: We have two-thirds of all Americans who are overweight or obese, and the costs are nearing $150 billion a year. The sheer magnitude of the problem really requires us to address it more aggressively and thoughtfully than we have. STEIN: Ferguson's been gathering together anti-obesity advocates, public health experts, government officials and others to try to figure out what the FDA should do. And the fact that there isn't, you know, medical treatments for obesity, including pharmaceuticals, really is a challenge, considering how big the problem is in this country. STEIN: Part of what's going on is that the FDA's gotten a lot more cautious about approving new drugs in general. JANET WOODCOCK: There's been a long history with obesity drugs that we've had to take off the market. You recall the fen-phen episode, where a significant number of people got heart-valve defects.
STEIN: Woodcock argues that the FDA has to be extra-careful about weight-loss drugs, because chances are it won't just be obese people taking them. WOODCOCK: When you're talking about a drug where it could go into literally tens of millions of Americans, you know, there has to be attention to safety.
STEIN: So, what might look like a rare problem now could turn into another public health debacle.
Joe Nadglowski says the FDA wrongly still sees weight-loss drugs as diet pills - something frivolous, something girls swallow to look pretty.
NADGLOWSKI: We are not talking about medications to help someone lose five pounds to fit into their prom dress or wedding dress. We're talking about medications to help those who are struggling with the health impact of obesity. STEIN: So Nadglowski and others are pushing the FDA to ask new questions: Do the drugs help people fight off diabetes, heart disease, breathing problems like sleep apnea? Woodcock of the FDA says officials realize they may have to think about things in a new way.
WOODCOCK: We're trying to work through, like, with people who are obese do have high risk, and therefore it would be worthwhile for them to take a drug, even if it had a certain amount of risk.
STEIN: Vivus hopes the FDA will agree those benefits will outweigh some of the risks, including the concerns about birth defects. The company is submitting new data it says show that the risk is lower than it had been feared. WADE: I need to lose 20 more pounds again, and I need the help, because I've been trying really hard to get this 20 pounds back off. STEIN: The dilemma for the FDA is figuring out the right balance of risks and benefits for powerful weight loss drugs like Qnexa. Whatever it decides, the agency has already scheduled a two-day hearing next month to help figure out the best way to judge obesity drugs.



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