FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health.
Table of contents
- Public Notification: CONTROL All Natural Sexual Enhancement Contains Hidden Drug Ingredient
- Related Consumer Updates
- Public Notification: Blue Pearl All Natural Male Enhancement contains hidden drug ingredient
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- FDA isn’t alone in targeting male enhancement products laced with drugs!
The case led to an indictment, which the U. Department of Justice is prosecuting, FDA added. For years, leaders of trade groups representing the dietary supplement industry have encouraged FDA to criminally prosecute marketers of drug-laced products fraudulently marketed as dietary supplements, such as the Rhino products identified by FDA. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market.
However, it is not possible for the agency to test and identify all tainted products. Claims that sound too good to be true probably are; search for information using noncommercial sites rather than depending on information provided by sellers.
The agency encouraged consumers to report information through its MedWatch Safety Information program if they suffer an adverse health effect possibly related to a dietary supplement or find defects in the quality or safety of a supplement. Hide comments. Thus far, FDA lab tests have found that nearly of these products contain undisclosed drug ingredients. These can include the same active ingredients found in prescription drugs that are FDA-approved for the treatment of erectile dysfunction ED , such as Viagra, Cialis and Levitra.
Public Notification: CONTROL All Natural Sexual Enhancement Contains Hidden Drug Ingredient
Not only do these products contain undisclosed drug ingredients, but they also sometimes may include combinations of undisclosed ingredients or excessively high doses, both potentially dangerous situations. Daniel Dos Santos, Pharm. Even more troubling is that many of the hundreds of products FDA has tested contained high doses of undeclared or hidden mixtures of different drug ingredients. For example, one of these tainted products included 31 times the prescription dose of tadalafil the active ingredient in Cialis , in combination with dapoxetine, an antidepressant that is not approved by FDA.
Unlike prescription and some non-prescription drugs, many dietary supplements may be legally marketed without a prior FDA evaluation of their safety and effectiveness. FDA typically investigates dietary supplement products after they are marketed, for example, as a part of routine or for-cause facility inspections, or after it receives reports associating them with adverse events.
The big risk for unsuspecting men is that many of the unlabeled drug ingredients in these deceptive products can interact dangerously with other drugs they are taking, such as heart disease medicines. For example, taking a product that contains sildenafil the active ingredient in Viagra in addition to certain drugs containing nitrates may lower blood pressure to an unsafe level.
People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed drugs containing nitrates, and men with those conditions commonly suffer from erectile dysfunction.
These undeclared ingredients are phosphodiesterase type-5 PDE-5 inhibitors, which can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Related Consumer Updates
People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. Over the past decade, the FDA has posted on its website hundreds of public warnings and recall announcements related to these types of fraudulent products. However, FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true.
The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market.
Public Notification: Blue Pearl All Natural Male Enhancement contains hidden drug ingredient
However, it is not possible for the agency to test and identify all tainted products. If you are using or considering using any product marketed as a dietary supplement, the FDA suggests that you:. The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.