[12-4-2019] The Food and Drug Administration is advising consumers not to purchase or use Detox Plus, a product promoted for digestive health. This product was identified during an examination of imported goods.
FDA laboratory analysis confirmed that Detox Plus contains tadalafil, paynantheine, and mitragynine. Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Paynantheine and mitragynine are alkaloids found in the Mitragyna speciosa plant, commonly known as kratom, which grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. FDA is concerned that kratom, which affects the same opioid brain receptors as morphine, appears to have properties that expose users to the risks of addiction, abuse, and dependence. There are no FDA-approved uses for kratom.
Health care professionals and patients 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:
- 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 products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, or 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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