Products found to contain undeclared medicines
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| The United States: Public Notification: Slyn Both contains hidden drug ingredients fluoxetine and orlistat |
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use Slyn Both, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Slyn Both 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).
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.
FDA laboratory analysis also confirmed that Slyn Both contains orlistat. Orlistat is commercially available as Xenical, a prescription medication for the management of obesity, and as Alli, an over-the-counter product for weight-loss. Rare, but serious side effects that may occur with the use of orlistat include: allergic reactions, symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, or yellowing eyes/skin), and symptoms of kidney stones (such as back pain, pain when urinating, or pink/bloody urine). Orlistat may also reduce the absorption of certain vitamins and interact with other medications a consumer may be taking.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm473617.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, November 20, 2015
Issued at HKT 16:30
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