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Supplement Recalls: FDA Warns Against Products Containing ‘Hidden Drug Ingredient’
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Supplement Recalls: FDA Warns Against Products Containing ‘Hidden Drug Ingredient’

The US Food and Drug Administration announced that two dietary supplements sold to support men’s health were recalled due to undeclared “hidden drug ingredients.”

The agency adds that unlisted ingredients may cause “life-threatening” drops in blood pressure when used with other prescription drugs.

Just a few days ago, Two other men’s health supplements It was found to contain the same unlisted ingredients.

VitalityXtra and PeakMax are marketed as nutritional supplements to increase men’s performance and energy. These products were voluntarily recalled by California-based company VitalityVita.com after they were found to contain sildenafil, the active ingredient in Viagra, and diclofenac, an FDA-approved medication used to treat pain and inflammation. It was determined that both products contained sildenafil, while diclofenac was only found in PeakMax. However, neither drug was advertised on the supplements’ packaging.

The table below shows the affected products:

Details of dietary supplements recalled through unlisted drug ingredients.

“Consumption of undeclared sildenafil-containing products may interact with nitrates found in some prescription medications (such as nitroglycerin) and cause a significant drop in blood pressure that can be life-threatening.” fda “People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates,” the statement made on November 6 said.

Among the products’ target demographic, adult men who use nitrate-based medications to manage heart conditions are most at risk, the agency added.

Diclofenac can also interact with other medications, but can also cause side effects on its own. “Use of undeclared diclofenac-containing products may cause serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines, as well as cardiovascular events such as heart attack and stroke,” the FDA said in a statement. he said. .

VitalityVita has notified its distributors and consumers about the incident and plans to return all recalled products.

“Consumers with VitalityXtra or PeakMax capsules lot number 230811 should discontinue use of the product,” the FDA said. “Consumers should consult their doctor or healthcare provider if they experience any problems they may have related to taking or using this medication.”

The FDA warned that VitalityXtra and PeakMax, as well as many other dietary supplements, are classified as “unapproved” drugs and have not been subject to the same level of safety and effectiveness review as approved pharmaceutical productions.

“The FDA is unable to test and identify all products marketed as dietary supplements that contain potentially harmful hidden ingredients,” the administration said. “Consumers should be careful”

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A man pours pills from a bottle into his palm. Two dietary supplements have been recalled after “hidden” drugs were found in them that were not listed on the label.

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