A male sexual performance enhancement supplement, sold over the counter across the U.S., has been recalled for being tainted with unapproved drug ingredients.
The supplement is called BLUEFUSION, and it is manufactured by Ata International Inc. The company is recalling certain lots of the male supplement after findings that the product was tainted with male erectile dysfunction drugs and other substances that were not declared on the packaging.
Specifically, the pills tested showed the presence of the drugs sildenafil and tadalafil, both of which are drugs approved by the US Food and Drug Administration for the treatment of male erectile dysfunction. These two drugs are classified as phosphodiesterase, or PDE-5, inhibitors. The BlueFusion pills also contained the presence of desmethyl carbodenafil and dithiodesmethyl carbodenafil, two substances that are also PDE-5 inhibitors used to treat erectile dysfunction, and therefore carry the same clinical risks as the other ingredients.
The FDA enforced the recall because these drugs were not declared active ingredients on the packaging and labeling of the product. This absence of labeling and information to the consumer renders the entire supplement product unapproved by the FDA, because the agency cannot attest to its effectiveness or overall safety. Therefore, the product is now under recall.
In support of the recall, the FDA warned that it could be dangerous to consumers to ingest a product with undeclared PDE-5 inhibitors. When combined with some prescription drugs, these supplements could be deadly. Experts say that the active ingredients in these drugs could have an unintended interaction with nitrates in other prescription drugs, resulting in a sharp reduction in blood pressure to extremely low, life-threatening levels.
Consumers particularly at risk are those men with high blood pressure, high cholesterol, diabetes or heart disease. Consumers with these issues often already take prescription drugs with nitrates—and therefore at risk for the deadly combination of chemicals.
The FDA’s recall notes that these BlueFusion capsules were sold over the counter in single packages of one dose. The product is promoted as a “safe” and “effective” way for men to enhance their sexual performance and erectile function, without having to take expensive prescription drugs. The
packaging instructs consumers to take one pill every three days, and even claims that in addition to the sexual benefits the product can boost energy and overall performance.
But all of those promises mean nothing if the product could be deadly. Therefore, the FDA has pushed this recall of all BlueFusion products until the product’s labeling of ingredients is corrected to comply with FDA regulations.
In the meantime, the agency is urging consumers to call their doctor if they have experienced any problems, particularly related to blood pressure, while taking the BlueFusion product. Likewise, Ata International Inc. is notifying known consumers about the issue, and the manufacturer is accepting returns of all products. Both the FDA and the company are urging distributors and sellers of the BlueFusion supplement to cease its distribution and return all product to the manufacturer.
If you are taking BlueFusion and have experienced any adverse issues or health problems, the FDA asks you to report to the their MedWatch program.