[7/27/2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Maxx Easy, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Maxx Easy contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
FDA laboratory analysis confirmed that Maxx Easy contains lorcaserin, a controlled substance and the active ingredient in the FDA-approved prescription drug Belviq®, used for chronic weight management in some overweight or obese adults. Lorcaserin may cause psychiatric disturbances and impairments in attention or memory. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
FDA laboratory analysis also confirmed that Maxx Easy contains orlistat. Orlistat is commercially available as Xenical, a prescription medication for the management of obesity, and as Alli, an over-the-counter product for weight-loss. Rare, but serious side effects that may occur with the use of orlistat include: allergic reactions, symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, or yellowing eyes/skin), and symptoms of kidney stones (such as back pain, pain when urinating, or pink/bloody urine). Orlistat may also reduce the absorption of certain vitamins and interact with other medications a consumer may be taking.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
- Download and complete the form , then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.