New Weight Loss Drug FDA Approved in Time for New Year Resolutions
Just in time to help dieters tackle their New Year’s resolution for weight loss, the FDA reports approval of an injectable drug that studies show have helped obese patients lose at least 5 percent of their body weight.
In a recent news release just before Christmas, the U.S. Food and Drug Administration reported that they have approved a new weight loss drug called “Saxenda” to help obese patients with a body mass index (BMI) of 30 or greater or who have a BMI of 27 or greater with at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol.
“Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related comorbid condition,” stated James Smith, M.D., M.S., acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research.
Clinical trials of this new weight loss drug showed promise of weight loss success when used in conjunction with lifestyle modification counseling, a reduced-calorie diet and regular physical exercise.
One study involving patients without diabetes showed an average weight loss of 4.5 percent from baseline compared to treatment with a placebo at one year. In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with a placebo.
Another study, this time including patients with Type 2 diabetes, demonstrated an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with a placebo.
The FDA notes that Saxenda should not be used in combination with the diabetes drug Victoza or any others within the same class of drugs that contain the same active ingredient―liraglutide.
During the clinical trials, common side effects observed in patients taking Saxenda included nausea, diarrhea, constipation, vomiting, low blood sugar, and decreased appetite. In some patients, more serious side effects reported included pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts.
The FDA recommends that if a patient has not lost at least 4 percent of baseline body weight after taking Saxenda for 16 weeks, that it should be discontinued as it is unlikely those patients will benefit from weight loss due to the drug.
If you are unsure if Saxenda is right for you, talk to your physician about the pros and cons of Saxenda and keep an eye out for further news as the FDA is requiring post-marketing studies of Saxenda that include:
• Clinical trials to evaluate dosing, safety, and efficacy in pediatric patients.
• A study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rat.
• An MTC (medullary thyroid carcinoma) case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda.
• An evaluation of the potential risk of breast cancer with Saxenda
For more about weight loss success for the New Year, here is an informative article about how to stick to that New Year weight loss resolution.
Image Source: Courtesy of Wikimedia Commons
Reference: FDA news release― “FDA approves weight-management drug Saxenda”