[10/30/2024] The Food and Drug Administration is advising consumers not to purchase or use ITCHA XS, a product promoted and sold for weight loss on various websites, and possibly in some retail stores. This product was identified during an examination of international mail shipments.
FDA laboratory analyses confirmed that various samples of ITCHA XS contain either fluoxetine or bupropion not listed on the product label. Fluoxetine and bupropion are active ingredients in FDA-approved drugs used to treat conditions including depression, bulimia, obsessive-compulsive disorder and smoking cessation. These medications require a prescription from a licensed health care professional.
Use of fluoxetine may cause serious side effects including suicidal thinking, abnormal bleeding, and seizures. This hidden drug ingredient may interact with other medications, leading to serious side effects including ventricular arrhythmia (abnormal heart rate) or sudden death.
Use of bupropion may cause serious side effects such as increased risk of suicidal thoughts or actions, seizures, increased blood pressure, manic episodes, and unusual thoughts or behaviors. This hidden drug ingredient may interact with other medications, in potentially life-threatening ways. Use of bupropion poses a serious threat to consumers because it may result in overdose, which can cause seizures, hallucinations, loss of consciousness, and even death.
Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Note: This notification is to inform the public of products potentially marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, pain relief 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.
Refer to the links below for more information:
