Supplement Recall As Warning of ‘Life-Threatening’ Interaction Issued – Newsweek
Two dietary supplements have been recalled after they were found to be contaminated with an unlisted…….
Recall of Dietary Supplements Contaminated with Unlisted Drug
Two dietary supplements have been recalled by the Food and Drug Administration (FDA) after they were found to contain an unlisted drug, which can have “life-threatening” consequences if used in combination with other medications. The agency issued a warning about this potential danger.
California-based supplement companies Veata LLC and Boulla LLC voluntarily recalled the supplements—Endurance Pro Energy Boost and Boom Max—on August 14 due to their containing sildenafil, the active ingredient in Viagra, which was not listed on their packaging. These products are marketed as dietary supplements to enhance male performance and energy.
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The FDA stated that “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.” People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Sildenafil is a PDE5 inhibitor and works by increasing blood flow to the penis, helping to stimulate and maintain an erection. It is also used to treat pulmonary hypertension (high blood pressure in the arteries of the lungs), where it relaxes the muscles in the blood vessel walls.
Sildenafil tablets can cause various 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 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.
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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.
This 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.
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The FDA, in a statement on June 20 after the hidden drugs were first detected, said “FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.” The administration advised consumers to exercise caution.
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Photo of a man taking supplements. The FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. This photo was taken by Kanur Ismail/Getty.
