Products found to contain undeclared medicines
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| The United States: Public Notification: Hard AF! contains hidden drug ingredients sildenafil and acetaminophen |
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The US Food and Drug Administration (FDA) is advising consumers not to purchase or use Hard AF!, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores.
FDA laboratory analysis confirmed that Hard AF! contains sildenafil and acetaminophen. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA’s approval of Viagra is restricted to use under the supervision of a licensed health care professional. 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.
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 Hard AF! poses a serious threat to consumers because it may result in unintentional 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. Victims of unintentional 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/medication-health-fraud/public-notification-hard-af-contains-hidden-drug-ingredients
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Dec 9, 2021
Issued at HKT 15:00
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