Supplement Recalls: FDA Warns of Products With ‘Hidden Drug Ingredient’

Two dietary supplements, sold to support men’s health, have been recalled due to undeclared “hidden drug ingredients,” the U.S. Food and Drug Administration says.
The unlisted ingredients can cause “life threatening” drops in blood pressure when used in combination with other prescription drugs, the agency adds.
Just days ago, two other men’s health supplements were found to contain the same unlisted ingredients.
VitalityXtra and PeakMax are marketed as dietary supplements to enhance male performance and energy. They 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 drug used to treat pain and inflammation. Both products were found to contain sildenafil while diclofenac was only found in PeakMax. However, neither drug had been advertised on the supplements’ packaging.
The table below shows the products that were affected:
“Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening,” the FDA said in a statement on November 6. “People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”
The agency added that, among the products’ target demographic, adult males who use nitrate-based medication to manage heart conditions are the most at risk.
As for diclofenac, the ingredient may also interact with other medications, but it can also cause side effects in its own right. “Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines,” the FDA said in a statement.
VitalityVita has notified its distributors and consumers of the incident and is arranging for the return of all recalled products.
“Consumers that have VitalityXtra or PeakMax capsules lot number 230811 should stop using the product,” the FDA said. “Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.”
The FDA warned that VitalityXtra and PeakMax, as well as many other dietary supplements, are classed as “unapproved” drugs and have not undergone the same level of safety and efficacy scrutiny as approved pharmaceutical productions.
“FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients,” the administration said. “Consumers should exercise caution.”
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