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Products found to contain undeclared medicines

 
The United States: Public Notification: Slim Bio Capsules contain hidden drug ingredients sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydramine
 
The US Food and Drug Administration (FDA) is advising consumers not to purchase or use Slim Bio Capsules, a product promoted for weight loss. This product was identified during an examination of international mail shipments. FDA laboratory analysis confirmed that Slim Bio Capsules contain sibutramine, N-desmethylsibutramine, sildenafil, tadalafil, benproperine and diphenhydramine.

Sibutramine is a controlled substance that was removed from the market in Oct 2010 for safety reasons. N-desmethylsibutramine is a substance structurally similar to sibutramine. 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.

Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Benproperine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

Diphenhydramine is an over-the-counter antihistamine used for seasonal allergy treatment. Antihistamines may cause drowsiness and affect mental alertness.

Please refer to the following website in FDA for details: http://www.fda.gov/Drugs/ResourcesForYou/../ucm629874.htm

In Hong Kong, the above product is not a registered pharmaceutical product.

Ends/Tuesday, Jan 29, 2019
Issued at HKT 16:00
 
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