Two dietary supplements have been recalled after they were found to be contaminated with an unlisted drug, the Food and Drug Administration (FDA) reported. When used in combination with other medications, this drug can have "life-threatening" consequences, the agency warn.
California-based supplement companies Veata LLC and Boulla LLC voluntarily recalled the supplements on August 14 after they were found to contain sildenafil—the active ingredient in Viagra.
The products in question—Endurance Pro Energy Boost and Boom Max—are marketed as dietary supplements to enhance male performance and energy. However, sildenafil was not listed on their packaging.
"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. "People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates."
Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors and works by increasing blood flow to the penis, helping to stimulate and maintain an erection. The drug is also used to treat high blood pressure, particularly in the arteries of the lungs, where it works by relaxing the muscles in the blood vessel walls.
Sildenafil tablets can cause several side effects, including nosebleeds, headaches, gastrointestinal symptoms, trouble sleeping, and erections that last longer than normal. More severe side effects include trouble breathing, vision problems, low blood pressure and heart problems.
Combining sildenafil with nitrates and guanylate cyclase simulators, used to control high blood pressure, can cause sudden and severe drops in blood pressure. However, to date, neither Veata LLC nor Boulla LLC have reported any adverse events related to the recall.
The FDA warned that Endurance Pro and Boom Max, 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.
The latest recall comes just weeks after a herbal pain relief supplement, Infla-650, was recalled due to three "hidden drug" ingredients that were not listed on the packaging.
"FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients," the administration said in a statement on June 20 after the hidden drugs were first detected. "Consumers should exercise caution."
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