Pharmaceutical

FDA warns of dangerous OTC supplements for erectile dysfunction

pills 435x290 FDA warns of dangerous OTC supplements for erectile dysfunctionMen seeking “all natural” products to enhance their sexual performance or to boost sexual stimulation should be wary of dietary supplements or foods that make such claims because they may contain hidden drug ingredients that can be harmful to their health, the Food and Drug Administration (FDA) warns.

The FDA has conducted laboratory tests on hundreds of over-the-counter libido-boosting supplements and found that nearly 300 of them contain drug ingredients not listed on the product’s label. Some of these drug ingredients include prescription medications that are FDA-approved for the treatment of erectile dysfunction, such as Viagra, Cialis and Levitra. In some cases, supplements contained combinations of these drugs or excessively high doses – both of which could lead to deadly consequences.

Even a cautious consumer can’t tell that these products are, in fact, tainted with undisclosed drug ingredients, because their labels do not list the potentially hazardous ingredients, says M. Daniel Dos Santos, Pharm.D, Ph.D., of the FDA’s Division of Dietary Supplement Programs. Consumers may be misled to believe these products are safe because their labeling often suggests they are “all-natural” or “herbal” alternatives to FDA-approved prescription drugs for the treatment of ED (erectile dysfunction).

“We’re finding an alarming number of these products sold online and in retail stores. They’re 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.

Viagra, Cialis or Levitra – or a combination of the drugs – can cause serious drug interactions if combined with other medications including those for heart disease. The drugs can also lower blood pressure to unsafe levels. Before taking these medications, it is advised that patients to consult with a doctor to ensure the medication is safe based on their medical history.

The FDA also said it doesn’t know how or where the products were manufactured and many could be manufactured in overseas facilities that have not been inspected by the FDA. “Some of these ingredients in these products have chemicals that have never undergone any type of safety analysis in the United States. You just don’t know what you’re getting,” says Brad Pace, regulatory counsel at FDA’s Health Fraud Branch.

The FDA has issued numerous alerts warning consumers and health care professionals about potentially dangerous products. It also works to stop the sale of illegal products and have them voluntarily recalled or destroyed.

As part of this mandate, FDA sends advisory letters to companies warning that they are breaking the law and must stop. Failure to cease illegal behavior could lead to seizures, import alerts, injunctions, recalls and criminal prosecutions. An import alert allows FDA to detain, without physically examining, products that appear to violate certain parts of the Food, Drug, and Cosmetic Act.

Nonetheless, some products are still in the marketplace. That’s why consumers should consult their health care professional before taking a new supplement, the FDA advises.

Source: FDA