FDA Approves Retail Availability of Qsymia Weight Loss Drug

by Kerri Seidler on June 13, 2013 · Comments | Weight Loss

Qsymia Weight Loss DrugThe weight loss drug Qsymia will soon be available at retail pharmacies following approval from the Food and Drug Administration for a change to the distribution options specified in the Risk Evaluation and Mitigation Strategy (REMS).

REMS are required by the FDA when drugs are potentially harmful, especially when used in ways other than intended. A REMS can include a Medication Guide, Patient Package Insert, a mandatory Pharmacist Consultation, or other elements to assure safe use.

When Qsymia was initially approved by the FDA in 2012, the REMS limited the sale of the drug to mail-order pharmacies to ensure women were given instructions on how to use the drug and to prevent pregnant women from taking the drug in order to reduce birth defects.

Now, retail pharmacies that go through a certification process will be able to provide Qsymia, in addition to the existing network of certified mail-order pharmacies.

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The Best Day of the Week for Surgery

by Kimberly Taylor on May 30, 2013 · Comments | Weight Loss Surgery

Bariatric Surgery Day of WeekWhen scheduling your elective surgery, you may want to think twice about the day of the week you decide to undergo an operation as it just may make a difference in the outcome.

Researchers looking into the association between mortality and the day of elective surgical procedure found that the overall risk of death within 30 days for patients undergoing elective surgery increased with each day of the week on which the procedure was performed.

In other words, it appears better to schedule your elective surgery for Monday than at the end of the week or at the weekend.

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Medical Groups Issue Updated Guidelines for Weight Loss Surgery

by Kerri Seidler on April 24, 2013 · Comments | Weight Loss Surgery

Updated Bariatric Surgery GuidelinesThe American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery have updated their guidelines for weight loss surgery based on the most current clinical evidence.

The guidelines provide recommendations pertaining to the care of bariatric surgery patients before, during, and after surgery. The recommendations are developed to assist health care professionals in medical decision making for specific clinical conditions.

Some of the topics discussed in the update are the gastric sleeve procedure, bariatric surgery in specific patient groups (mild obesity, type 2 diabetes, age), nutritional and metabolic issues, assessment of comorbidities, informed consent, and psychosocial and behavioral evaluations.

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Weight Loss Expectations vs Risk in Bariatric Surgery Patients

by Kerri Seidler on April 16, 2013 · Comments | Bariatric Surgery Study

Bariatric Surgery Risk and RewardBariatric surgery has been shown to greatly improve health and lead to significant weight loss, but all too often patient expectations are not consistent with clinical reality.

A new study published online in March in JAMA Surgery examines this matter and provides additional insight into the unrealistic expectations of patients considering weight loss surgery.

Researchers interviewed hundreds of patients considering weight loss surgery and found that most weight loss surgery patients have high weight loss expectations and are willing to accept more risk to achieve those expectations.

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Weight Loss and Adverse Events of REALIZE Adjustable Gastric Band-C at 2 Years

by Kimberly Taylor on March 27, 2013 · Comments | Bariatric Surgery Study

REALIZE Adjustable Gastric Band-CThe REALIZE Adjustable Gastric Band-C appears to be as safe and effective as the first generation REALIZE Band for weight loss, according to results of the first multi-institutional study in a United States population of the newest version of the REALIZE Band.

Launched in 2008, the REALIZE Band-C features the same clinically proven soft, low-pressure balloon system as the original REALIZE Band, but with a streamlined pre-curved design for easier placement and an expanded adjustment range that can accommodate larger patients.

After analyzing study patient outcomes during the first 24 months after surgery, researchers concluded that significant weight loss is achievable with the REALIZE Band-C and that the low rate of adverse events reflect positively on the REALIZE Band-C characteristics.

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How Many Procedures Does it Take to Overcome Learning Curve of Laparoscopic Gastric Bypass Surgery?

by David Alexander on March 18, 2013 · Comments | Gastric Bypass Surgery

Surgery Learning CurveA new study provides additional insight into overcoming the learning curve of laparoscopic Roux-en-Y gastric bypass surgery and minimizing the risks of adverse outcomes.

Laparoscopic Roux-en-Y gastric bypass surgery is a technically challenging procedure with the potential for catastrophic complications. The complex operation is associated with a long and steep learning curve and involves high-risk patients with morbid obesity.

In the hands of a skilled and experience bariatric surgeon, laparoscopic gastric bypass surgery can be a safe and effective surgical treatment of morbid obesity. But just how much experience does it really take to become proficient in performing laparoscopic Roux-en-Y gastric bypass?

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Study Challenges Economic Benefit of Bariatric Surgery

by Kimberly Taylor on February 25, 2013 · Comments | Weight Loss Surgery

Healthcare CostsIf bariatric surgery does not reduce overall healthcare costs, is it still worth it? Will insurance companies still cover it? Should they? Or should bariatric surgery be excluded from coverage just like many other types of elective procedures for personal quality of life reasons.

Many studies have been done examining the safety and effectiveness of bariatric surgery, with results showing that it is the best treatment option we currently have for sustaining long-term weight loss and improving the health and quality of life of obese individuals.

But in addition to health benefits, what about cost benefits? We are often told about the cost savings of bariatric surgery on healthcare costs over time, but a new study challenges that claim.

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Gastric Banding Shown Safe and Effective for Long-Term Weight Loss

by Kerri Seidler on January 22, 2013 · Comments | Lap Band Surgery

Obesity SurveyAdjustable gastric banding is a safe and effective treatment option for obesity in the long-term, according to a new study published in the journal Annals of Surgery.

The study included data from a 15-year follow up study of gastric banding patients from a single center in Australia as well as a systematic review of peer-reviewed bariatric surgical literature for weight loss at 10 years or more after bariatric surgery.

As few long-term studies have been completed on any procedure over the 50-year history of bariatric surgery, the findings provide valuable insight into surgical options for obesity and long-term outcomes after bariatric surgical procedures.

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Recruiting Begins for Clinical Trial of EndoBarrier

by Kerri Seidler on January 16, 2013 · 1 comment | Experimental Treatments

Diabetes ENDO TrialDoctors across the United States are now recruiting hundreds of obese and diabetic patients for the U.S. pivotal clinical trial of EndoBarrier, the ENDO Trial, GI Dynamics announced yesterday.

EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between food and a portion of the intestine wall. The EndoBarrier alters the digestion process, resulting in improved glucose control and significant weight loss during the implant period.

Treatment with EndoBarrier has showed promising results in studies done to date, with more than 500 patients. Already approved for use in select regions of Europe, South America, and Australia, successful completion of the ENDO Trial is the first step for pursuing commercial status in the United States.

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Surprising Misperceptions About Weight Status and Obesity Health Risks

by Kerri Seidler on January 9, 2013 · Comments | Obesity Research

Obesity SurveyAlthough the majority of the American public views obesity as a serious public health issue, a surprising number tend to misperceive their own weight status and do not fully understand all the health consequences of being obese, according to results from The Associated Press-NORC Center for Public Affairs Research survey.

The results showed that nearly half of the overweight, but not obese, respondents misperceived their own weight status and thought their weight was about right. And while many of the respondents were aware of the link between obesity with heart disease and diabetes, most were less likely to mention other serious health impacts associated with being overweight or obese.

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