[9-6-2019] The Food and Drug Administration is advising consumers not to purchase or use JaDera PLUS, a product promoted for weight loss. This product was identified during an examination of international mail shipments.
FDA laboratory analysis confirmed that JaDera PLUS contains sibutramine, N-desmethylsibutramine, and benproperine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. N-desmethylsibutramine is a substance structurally similar to sibutramine. Sibutramine poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or heart rate in some people and may present a significant risk for people 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.
Benproperine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.
Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at 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 products marketed as dietary supplements or conventional foods with hidden drug ingredients 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.
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