On August 9, 2016, the FDA issued five public notifications advising consumers not to purchase or use a number of products, including:
All five products were identified during an examination of international mail shipments, and laboratory analyses later confirmed that they contain various harmful and hidden drug ingredients.
The FDA is warning consumers not to use or purchase Citrus’ Fit and Adelgazantes R-II, which are both promoted for weight loss. The FDA’s lab analyses identified and confirmed that both products contain sibutramine.
Sibutramine, a controlled substance, was removed from the market for safety reasons in October 2010. According to the FDA’s notice, “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.” Furthermore, the product could also have life-threatening interactions with other medications being taken by consumers.
In addition to sibutramine, FDA’s analysis of Citrus’ Fit also determined that the product contains desmethylsibutramine, a substance similar in structure to sibutramine, thus furthering the Agency’s safety concerns associated with the product’s use.
During FDA’s lab analyses of Boss-Rhino Gold X-tra Strength, Anaconda Strong Formula, and De Guo Hei Bei (徳国黑倍), the Agency found that the products contain sildenafil. Sildenafil is the active ingredient in Viagra, the FDA-approved drug indicated for the treatment of erectile dysfunction (ED). Although sildenafil is approved by FDA in some products, the Agency notes that it “may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.” Nitrates are often taken by men with diabetes, high blood pressure, high cholesterol, or heart disease.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of any of the above mentioned products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
For additional information, view the Agency’s public notifications:
October 8, 2015
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