Products found to contain undeclared medicines
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| The United States: Public Notification: Dream Body Advanced + Acai Weight Loss & Cleanse contains hidden drug ingredients sibutramine, fluoxetine and sildenafil |
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use Dream Body Advanced + Acai Weight Loss & Cleanse, a product promoted and sold for weight loss on various websites, including www.dreambodyweightloss.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that Dream Body Advanced + Acai Weight Loss & Cleanse contains sibutramine, fluoxetine and sildenafil.
Sibutramine is a controlled substance that was removed from the 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Fluoxetine is an FDA-approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD). Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.
Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm510614.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, July 12, 2016
Issued at HKT 13:00
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