Dietary supplement recall: FDA warns about products with “hidden drug ingredients”

Two dietary supplements sold to support men’s health have been recalled due to undeclared “hidden drug ingredients,” according to the U.S. Food and Drug Administration.

The unlisted ingredients can cause “life-threatening” drops in blood pressure when combined with other prescription medications, the agency adds.

Just a few days ago, two other men’s supplements were discovered to contain the same unlisted ingredients.

VitalityXtra and PeakMax are marketed as dietary supplements to increase male performance and energy. They were voluntarily recalled by California-based 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 present in PeakMax. However, neither drug was advertised on the supplement packaging.

The following table shows the affected products:

“Consumption of products containing undeclared sildenafil may interact with nitrates in some prescription medications (such as nitroglycerin) and cause a significant decrease in blood pressure, which may be life-threatening,” the FDA said in a Nov. 6 statement. “People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The agency added that among the products’ target population, adult men taking nitrate-based medications to treat heart disease were most at risk.

As for diclofenac, the ingredient can also interact with other medications, but can also cause side effects on its own. “Use of products containing undeclared diclofenac may cause an increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal harm such as bleeding, ulceration, and fatal perforation of the stomach and intestines,” the FDA said in a statement.

VitalityVita has informed its dealers and consumers of the incident and is initiating the return of all recalled products.

“Consumers who possess VitalityXtra or PeakMax capsules with lot number 230811 should discontinue use of the product,” the FDA said. “Consumers should contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this medicine.”

The FDA warned that VitalityXtra and PeakMax, as well as many other dietary supplements, are considered “unapproved” drugs and have not undergone the same level of safety and effectiveness testing as approved drug products.

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

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