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  7. Special Edition Platinum 10K contains hidden drug ingredients
  1. Medication Health Fraud

Special Edition Platinum 10K contains hidden drug ingredients

[2-10-2025] The Food and Drug Administration continues to advise consumers not to purchase or use Special Edition Platinum 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

Special Edition Platinum 10K may be harmful due to hidden drug ingredients

FDA laboratory analysis confirmed that Special Edition Platinum 10K contains acetaminophen not listed on the product label. This is in addition to the tadalafil and vardenafil listed below.  

Acetaminophen is a medicine used to reduce pain and fever that is found in many prescription and over-the-counter (OTC) drug products. Use of the product Special Edition Platinum 10K poses a serious threat to consumers because it may result in acetaminophen overdose, especially if it is used in combination with other acetaminophen-containing products. Acetaminophen overdose can cause liver damage (hepatoxicity), ranging in severity from abnormalities in liver function to acute liver failure, and even death. People who experience acetaminophen overdose may not seek prompt medical attention because the symptoms of liver damage can take several days to emerge, even in severe cases.  Acetaminophen may also cause serious skin reactions. Symptoms may include skin reddening, rash, and blisters.

[5-4-2023] The Food and Drug Administration is advising consumers not to purchase or use Special Edition Platinum 10K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

FDA laboratory analysis confirmed that Special Edition Platinum 10K contains tadalafil and vardenafil, the active ingredients in the FDA-approved prescription drugs Cialis and Levitra, respectively, used to treat erectile dysfunction. FDA approvals of Cialis and Levitra are restricted to use under the supervision of a licensed healthcare professional. These undeclared ingredients 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.

Healthcare 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 marketed as dietary supplements or conventional foods with hidden drug ingredients 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.

Refer to the links below for more information:

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