The 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.
When 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.
The 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.
Bariatric 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.
The 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.
A 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.
If 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.
Adjustable 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.
Doctors 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.
Although 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.
