[11-19-2015] 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.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
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