Pharmaceutical

FDA warns men not to use non-approved products for erectile dysfunction

viagra FDA warns men not to use non approved products for erectile dysfunctionThe Food and Drug Administration (FDA) is warning men not to be fooled by so-called dietary supplement or foods that promise to enhance sexual performance or increase sexual stimulation. These products may contain hidden drug ingredients or other undisclosed products that can be dangerous to your health.

The agency says it has found that nearly 300 of these products contain undisclosed drugs including the same active ingredient found in prescription drugs that are FDA-approved to treat erectile dysfunction, or ED, such as Viagra, Cialis and Levitra. However, these products also often contain combinations of undisclosed ingredients or excessively high doses, both of which the FDA says are “potentially dangerous situations.”

It is difficult for even cautious consumers to know if these products are tainted with undisclosed ingredients because they may be mislabeled or labeled with the words “all-natural” or “herbal,” which can mislead consumers into assuming they are safe.

“We are finding an alarming number of these products sold online and in retail stores. They are often sold in single-serving sizes in gas stations or vending machines. We’ve seen pills, coffees, chewing gum and dissolvable oral strips that contain hidden drug ingredients or untested chemicals,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Consumers have no way of knowing which drugs or ingredients are actualy in the product just by reading the ingredients on the label.”

Many of the hundreds of products the FDA has tested contained high doses of undeclared mixtures of different drugs. For example, one of the tainted products included 31 times the prescription dose of tadalafil, the active ingredient in the erectile dysfunction drug Cialis, in combination with dapoxetine, an antidepressant that is not even approved by the FDA.

Another danger is that these supplements can also interact with other dugs someone may be 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 can lower blood pressure to unsafe levels.

Even the prescription drugs Viagra, Cialis and Levitra carry risks that patients should weigh with their doctors before they can be prescribed. Viagra side effects include dizziness, headache, and a dangerous drop in blood pressure. The drugs have also been linked to an increased risk of melanoma, the most deadly form of skin cancer.

Research has shown that Viagra, which works through the same genetic pathway that makes melanoma more aggressive, can increase a user’s risk for melanoma by more than 80 percent. The risk remains for men who have used Viagra in the past but no longer take the drug.

Source: FDA