FDA Approves Saxenda for Weight Loss, Unapproved Dietary Supplements Recalled

FDA Approves Saxenda for Weight Loss, Unapproved Dietary Supplements Recalled
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December 30, 2014

A new weight loss drug has been approved by the U.S. Food and Drug Administration (FDA) as the agency continues to issue warnings about those that contain hidden and banned ingredients.

The FDA approved Saxenda, an injectable, for chronic weight management to be used in addition with a reduced-calorie diet and increased physical activity.

The drug is approved for use in adults with a body mass index (BMI) of 30 or more (obesity) or adults with a BMI of 27 or more (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia). BMI measures body fat based on a person's weight and height and is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention (CDC), more than one-third of adults in the United States are obese.

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used in combination with any other drug belonging to this class, including Victoza, a treatment for type 2 diabetes.

Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate.

In clinical trials, the most common side effects observed in patients treated with Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.

Unapproved Weight Loss Drugs Pulled from Shelves

Weight loss supplements made by Bethel Nutritional Consulting have been recalled after an FDA lab analysis found unapproved medications.

B-Lipo contains lorcaserin, a controlled substance and active ingredient in the FDA-approved prescription drug Belviq, which is also used for weight management. Lorcaserin may cause psychiatric disturbances and impairments in attention or memory and could have potentially life-threatening reactions when taken with other medications, including those used to treat depression and migraines.

Slim-K contains sibutramine, an analog of sibutramine, and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.

Both supplements were marketed and sold for weight loss on various websites and in some retail stores.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.