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  7. OneMultivitaminic GAF-Plus Advance may be harmful due to hidden drug ingredients and undeclared aspartame
  1. Medication Health Fraud

OneMultivitaminic GAF-Plus Advance may be harmful due to hidden drug ingredients and undeclared aspartame

[10-30-2024] The Food and Drug Administration is advising consumers not to purchase or use OneMultivitaminic GAF-Plus Advance, a product promoted and sold for pain on various websites including www.lipoblueadvance.com, and possibly in some retail stores.

FDA laboratory analysis confirmed that OneMultivitaminic GAF-Plus Advance contains dexamethasone, acetaminophen, and aspartame, which are not listed on the product label.

OneMultivitaminic GAF-Plus Advance
OneMultivitaminic Bottle

Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in OneMultivitaminic GAF-Plus may cause serious side effects when combined with other medications.

Consumers taking OneMultivitaminic GAF-Plus Advance should immediately consult their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a licensed health care professional for the risk or existence of adrenal suppression.

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 OneMultivitaminic GAF-Plus Advance 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 including skin reddening, rash, and blisters.

Aspartame is a food additive approved for use as a sweetener in food for the general population when made under good manufacturing practices and used under the approved conditions of use. However, people with difficulty metabolizing phenylalanine because of a rare genetic disorder called phenylketonuria (PKU) should avoid or restrict aspartame. The OneMultivitaminic GAF-Plus Advance label does not declare aspartame or include the required statement, PHENYLKETONURICS: CONTAINS PHENYLALANINE; therefore, the product poses a serious health risk to consumers with PKU because its use would result in unintentional consumption of aspartame.

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.

Please refer to the links below for more information:

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