The Food and Drug Administration (FDA) is advising consumers not to purchase or use Queen Slimming Soft Gel, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Queen Slimming Soft Gel contains sibutramine. 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 people and may present a significant risk for people 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.
Laboratory analysis also confirmed that Queen Slimming Soft Gel contains fluoxetine. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm534488.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, December 23, 2016
Issued at HKT 16:00
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