Tag Archives: fda approved

‘Stomach Pump’ Weight Loss Device Approved by FDA

Obese people who are struggling to lose weight may have a new option, but it may seem very unusual for some.

Asire Assist Bariatrics

FDA approves new ‘stomach pump’ weight loss device to cut a third of your calories. Photo by CBS News

The www.fda.gov approved a new device known as the AspireAssist. You do not have to undergo major surgery and it works by removing some of what is inside your stomach through a tube after you eat, cutting about a third of your calories.

The device is made up of a surgically placed tube in the stomach that removes food in the stomach after you eat just before the food is digested. Patients drain about a third of what is in their stomach,” says Katherine Crothall, PhD, president and CEO of Aspire Bariatrics, Inc., the developer of the device. I think that is a good percentage of contents removed that could lead to more weight loss that regular digestion.

The trial included 111 patients who had counseling about nutrition and exercise with 60 people who got the counseling alone. After twelve months, those who used AspireAssist lost an average of 12 percent body weight, while the counseling-only group lost over 3 percent.

The good thing is that both groups showed a little improvement in obesity related health issues such as diabetes and high blood pressure.

The device is intended for adults who are obese with a BMI of 35 to 55, who have not lost weight or kept the pounds off through non-surgical treatments. It is recommended for individuals to receive counseling on exercise and healthy eating so they will make long term lifestyle changes.

The thing I like most about this device is that it is less invasive than weight loss surgery and possibly a lot less risky. Surgery does lead to more weight loss though, says Stacy Brethauer, MD, a staff bariatric surgeon at Cleveland Clinic. He is familiar with the device but has to relation to the company.

Side effects of the AspireAssist include nausea, indigestion, diarrhea, constipation and vomiting, according to the FDA.

If you calculate the treatment, including the device placement, monitoring, lifestyle counseling and follow-up, you could be expected to pay anywhere from $8,000 to $13,000 in the first year. This is not so bad compared to the cost of weight-loss surgery, which could range from $30,000 to $35,000, says John Morton, MD, immediate past president of the American Society for Metabolic and Bariatric Surgery. Insurance may cover the cost for patients who qualify which is a great idea in my opinion.

It is hard to tell how big of a role this device can play in weight loss, but if patients use the device properly and stay dedicated, then there is no doubt they will lose weight.

Source: www.fda.gov “FDA approves AspireAssist obesity device” June 14, 2016

 

Leeman Taylor
Bachelor Degree in Criminal Justice
Real Estate Investor & Internet Marketer

New Weight Loss Diet Pill Acts As “Imaginary Meal”

Obese individuals seeking to lose weight have many FDA-approved prescription drugs to choose from including Belviq and newly approved Saxenda. There is still a long journey for better weight loss as scientists develop new fat loss alternatives every day.

Diet Pill Fexaramine - Ronald Evans

Evans and his colleagues develop Fexaramine, a compound that tricks the brain into feeling full, causing your body to burn fat. Salk Institute photo

Researchers at Salk Institute recently developed fexaramine; a pill that tricks the body into thinking it has consumed calories, causing it to burn fat. This new weight loss pill effectively stopped weight gain, controlled blood sugar, lowered cholesterol and decreased inflammation in mice, making it a great candidate for fast transition into human clinical studies (Evans et al. 2015). Many of the prescription drugs that we have currently on the market like caffeine-based drugs or appetite suppressants dissolve in the blood, but fexaramine stays in the intestines causing lesser side effects.

There was a study published earlier this month on how diet pills or weight loss supplements rarely work without diet or exercise but this new pill could really be an effective option for obesity. “This pill is like an imaginary meal” says Ronald Evans, director of Salk’s Gene Expression Laboratory and senior author of the new paper, published January 5, 2014 in Nature Medicine. “It sends out the same signs that normally happen when you eat a lot of food, so the body starts clearing out space to store it. But there are no calories and no change in appetite.”

Evans and his colleagues gave obese mice a daily pill of fexaramine for 5 weeks in which the mice stopped gaining weight, lost fat and had lower cholesterol and blood sugar levels than untreated mice (Evans et al. 2015). Obese patients who have trouble overeating can benefit greatly from fexaramine because they will feel less hungry and the body will burn calories fast with diet and exercise combined.

I agree that fexaramine may be safer in humans because it doesn’t make it to the bloodstream like other FXR targeting drugs. Administered under a physician’s guidance, this drug would work in combination with diet and lifestyle changes, much like weight loss surgeries or other obesity treatments.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: Evans, R. et al. “Imaginary Meal” tricks the body into losing weight” 5 January 2015 Salk Institute

Weight Loss Diet Pills Rarely Work

New weight loss supplements and diet pills are advertised everyday by drug companies claiming to help you lose weight fast. According to a new Consumer Report, diet pills rarely work and they aren’t even FDA approved (Olsen 2014).

Weight Loss Diet Pills

Weight loss supplements and diet pills rarely work, according to Consumer Reports. Clipart Photo

A national survey of about 3,000 Americans, were given supplements they believed to be safe and effective. One-fourth of the participants believed that the products had lesser side effects than over the counter or prescription medications, and about 20 percent thought the supplements were safer than prescription drugs because they’re “natural.” When we are searching for weight loss supplements, we don’t usually think about whether the product is actually FDA approved or even consult our primary care doctors for advice.

Peter Cohen, M.D., a physician at Harvard Medical School and the Cambridge Health Alliance who studies supplements says, “The barrage of advertising leads us to think there’s a magic way to melt away 10 pounds –even when we have no evidence that the supplements work.” Unlike over the counter and prescription drugs, supplements don’t have to be proven safe and effective before they hit stores (Olsen 2014). “Of all dietary supplements, the one for weight loss seems to cause the most harm –sometimes liver failure or even death,” Cohen says.

In the survey, a third of the participants who took the supplements didn’t lose weight. Another third lost a few pounds but only 9 percent lost all the weight they wanted and kept it off. The shocking part is that the supplements had little to do with it because 85 percent of the people followed a diet or exercise program (Olsen 2014).

This Consumer Reports survey basically shows us that there is no way around diet and exercise. Research proves that the key to fat loss is finding a diet that works for you. A recent review of 48 studies published in the Journal of the American Medical Association found that popular programs like Atkins, Jenny Craig, and Weight Watchers, all worked as well as the other. The dieters lost nearly 18 pounds after 6 months on average (Olsen 2014). Find a weight loss program like the Venus Factor for Women, that works for you and live a healthier, happier lifestyle.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: Olsen, D. “Taking diet pills? Don’t waste your money.” 30 December 2014 ConsumerReports.org

New Weight Loss Drug Saxenda FDA Approved

The new weight loss drug Saxenda (liraglutide) has been approved by the FDA for weight-management in addition to exercise and a low-calorie diet. This drug is approved for adults who suffer from obesity or who are overweight and have at least one weight-related issue such as type 2 diabetes, hypertension, or high cholesterol (FDA 2014). With more than one-third of adults in America overweight (CDC), this new drug can help millions lose weight and focus on a healthy lifestyle.

Saxenda Weight Loss Drug

New weight loss drug Saxenda is approved by FDA. Photo by PR Newswire

According to James Smith, M.D., M.S., acting director of the Division Evaluation of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research, “Obesity is a public health concern and threatens the overall well-being of patients.” He then goes on to say that Saxenda provides an additional treatment option for chronic weight management when combined with physical activity and a low-calorie diet (FDA 2014).

What is Saxenda?

Saxenda is a glucagon-like peptide-1 receptor agonist and should not be combined with any other drug in its class, including Victoza, a treatment for type-2 diabetes. On the other hand, the safety and effectiveness for treating type-2 diabetes has not been established for Saxenda.

In the clinical trials, 4,800 obese and overweight individuals with and without weight-related issues were evaluated. Approximately 50 percent of patients with type-2 diabetes, who were treated with Saxenda, lost at least 5 percent of their body weight compared with 16 percent of individuals treated with placebo (FDA 2014). Patients should be evaluated for 16 weeks to determine if the treatment is working or not.

What are the side effects of Saxenda?

Saxenda should not be used in individuals with a personal or family history of MTC or individuals with multiple endocrine neoplasia syndrome type-2. The most commonly observed side effects were nausea, vomiting, diarrhea, low-blood sugar, constipation, and reduced appetite. As any weight loss drug, there will be side effects but I still believe the benefits of Saxenda outweigh the bad and still should be considered as a weight management alternative.

Novo Nordisk manufactures and distributes the drug in Denmark and it is expected to be released in 2015.

Leeman Taylor
Senior Criminal Justice Major at Florida A&M University
Real Estate Investor & Internet Marketer

Source: FDA.gov “FDA approves weight-management drug Saxenda” 23 December 2014 U.S. Food and Drug Administration