Products found to contain undeclared medicines
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| The United States: Public Notification: Asunsa contains hidden drug ingredients sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac |
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The US Food and Drug Administration (FDA) is advising consumers not to purchase or use Asunsa, a product promoted for weight loss. This product was identified during an examination of international mail shipments. FDA laboratory analysis confirmed that Asunsa contains sibutramine, N-desmethylsibutramine, benzylsibutramine, phenolphthalein and diclofenac.
Sibutramine is a controlled substance that was removed from the market in Oct 2010 for safety reasons. N-desmethylsibutramine and benzylsibutramine are substances structurally similar to sibutramine. This product 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.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it may increase the risk of cancer.
Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm612797.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 10, 2018
Issued at HKT 16:00
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