FDA urges consumers to avoid sexual-enhancement drinks

LOS ANGELES — The Food and Drug Administration (FDA) on Thursday advised consumers not to buy or use two drinks sold as supplements for sexual enhancement.

The products, Rock Hard Extreme and Passion Coffee, are sold on websites and possibly in retail outlets, the agency said. Laboratory analysis indicated both contain sulfoaildenafil, an active pharmaceutical ingredient similar to sildenafil, the active ingredient in Viagra.

Sulfoaildenafil could interact with prescription medications that include nitrates, the FDA warned, lowering blood pressure to "dangerous levels." Nitrate-containing drugs often are prescribed for men with diabetes, high blood pressure or heart disease.

The warning arrives two weeks after the FDA warned dietary-supplement makers that it would crack down on illegal supplements.

"We want consumers to be aware that there are products masquerading as dietary supplements that pose significant dangers," said FDA Principal Deputy Commissioner Joshua Sharfstein.

Sharfstein said the FDA was concerned primarily with three types of supplements. One class is weight-loss products with active ingredients such as sibutramine, found in the drug Meridia, which was withdrawn from the market recently because of increased risk of heart attack and stroke. The other two are bodybuilding products that contain anabolic steroids or "steroid analogs," which can cause liver injury and increase risks for heart attack, stroke and death; and sexual-enhancement products such as Rock Hard Extreme and Passion Coffee.

Sharfstein said the products are labeled poorly, so consumers do not know what they are buying.

Dietary supplements, according to the FDA, are intended only as "an addition to a standard diet."

"If you have a drug product in it, it's not a supplement," said Judy Blatman, spokeswoman for the Council for Responsible Nutrition, an industry trade organization. "We're extremely supportive of the FDA's actions to warn consumers about products that are masquerading as supplements. ... they're illegal."

In an e-mail, FDA spokeswoman Siobhan DeLancey said the agency had found nearly 300 such "tainted products" among dietary supplements. She did not specify how many of those were sexual-enhancement products.

DeLancey also said the FDA had received reports of fatalities in people using illegal sexual-enhancement products.

The FDA advised consumers to stop using Rock Hard Extreme and Passion Coffee immediately, and to throw them away. The agency encouraged people who had experienced side effects from either drink to notify their doctor.