| ■ FDA Warns Men Not to Use 'Blue Steel' or 'Hero' Products | 2008.03.31 |
| Consumers shouldn't buy or use "Blue Steel" or "Hero" products sold as treatments for erectile dysfunction or sexual enhancement because they are considered unapproved drugs and haven't been proven safe or effective, the U.S. Food and Drug Administration warned. The products, promoted and sold over the Internet, contain undeclared ingredients that may have a dangerous effect on a person's blood pressure, the agency said. The products are labeled as all natural dietary supplements but don't qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in Viagra, the FDA said. "Because these products are labeled as 'all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in a prepared statement. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking." Men with diabetes, high blood pressure, high cholesterol, or heart disease often take prescription drugs that contain nitrates. Erectile dysfunction is common in these men, but they're advised against taking Viagra or similar drugs. Instead, some of these men look for "all natural" products to treat erectile dysfunction. Any men who have taken Blue Steel or Hero products should stop using them and consult their doctor if they've had problems that may have been caused by the products, the FDA said. |