Products found to contain undeclared medicines
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| The United States: Public Notification: Nuvitra contains hidden drug ingredients sibutramine and fluoxetine |
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The US Food and Drug Administration (FDA) is advising consumers not to purchase or use Nuvitra, a product promoted for weight loss. This product was identified during an examination of international mail shipments. FDA laboratory analysis confirmed that Nuvitra contains sibutramine and fluoxetine.
Sibutramine is a controlled substance that was removed from the market in Oct 2010 for safety reasons. 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.
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). The use of SSRIs has 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/resourcesforyou/../ucm616523.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Aug 14, 2018
Issued at HKT 15:00
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