Products found to contain undeclared medicines
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| The United States: Public Notification: Japan Hokkaido Slimming Weight Loss Pills Contain Hidden Drug Ingredients |
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use Japan Hokkaido Slimming Weight Loss Pills, a product promoted and sold for weight loss on various websites and in some retail stores. FDA laboratory analysis confirmed that Japan Hokkaido Slimming Weight Loss Pills contain sibutramine, benzocaine, phenolphthalein and diclofenac.
Sibutramine is a controlled substance that was removed from the US 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. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.
Benzocaine is a local anesthetic. It is the active ingredient in many over-the-counter (OTC) products used to relieve pain in the mouth and gums from a variety of conditions. Benzocaine use may cause methemoglobinemia, a rare, but serious and possibly fatal condition where the amount of oxygen that can be carried through the blood stream is greatly reduced.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
Diclofenac is a non-steroidal anti-inflammatory (NSAID) drug that can cause increased risk of cardiovascular events, such as heart attack and stroke. Diclofenac, like other NSAID drugs, can also lead to serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a healthcare professional as soon as possible.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm414375.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, September 16, 2014
Issued at HKT 17:00
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