men's sexual health, erectile dysfunction, testosterone deficiency, Peyronie's Disease,

January 20, 2011 08:30 ET

Men's Sexual Health Expert Dr. Ridwan Shabsigh, MD Discusses FDA Ban on Dietary Supplement "Man Up Now"

NEW YORK, NY--(Marketwire - January 20, 2011) - The U.S. Food and Drug Administration (FDA) has warned consumers to halt the use of a dietary supplement called Man Up Now, which is marketed to treat erectile dysfunction (ED). "The supplement claims to be herbal and natural, which may make consumers think the product is basically harmless and has no health risk, which could not be further from the truth," says Dr. Ridwan Shabsigh a men's health, ED, testosterone deficiency, and Peyronie's Disease treatment expert as well as director of the Division of Urology at Maimonides Medical Center in Brooklyn. "Sexual enhancement supplements are frequently marketed as natural remedies that function as well as prescription drugs, but sometimes contain prescription strength drugs and can expose consumers to unknown risks, injury or even death," said Dr. Ridwan.

Man Up Now, which is distributed by Synergy Distribution, is sold online and in some retail outlets in blister packs and in 6-, 12-, and 30-count capsule bottles, at a cost of $9.75 for three pills. To date, there have been no injuries reported with the use of the supplement but the FDA advises anyone who has experienced negative side effects from this or any other sexual enhancement product to see their doctor immediately.

The FDA has previously found many dietary supplements made for sexual enhancement to be potentially harmful because they are made with many of the same active ingredients, or varieties of these ingredients, found in FDA-approved drugs. Man Up Now contains a variant of sildenafil, the active ingredient in Viagra. The variant, sulfoaildenafil, is a chemical that could interact with other prescription drugs that contain nitrates, such as nitroglycerin, which could lower blood pressure to a dangerous level. This can lead to dizziness, light-headedness or even a stroke. Just last week, Intelli Health Products announced a recall for its Duro Extend ED product, because it contained sulfoaildenafil.

In fact, according to the FDA, one-third of "dietary supplements" purchased online that claim to treat sexual enhancement or treat erectile dysfunction contain undisclosed prescription drug ingredients or variants. Some products contained sildenafil or vardenafil, the active ingredient in Levitra, which is another drug approved by the FDA to treat ED. The failure of manufacturers to disclose these ingredients could lead to serious side effects in consumers.

According to the National Institutes of Health, about 30 million men in the U.S. suffer from erectile dysfunction. "It's so disturbing to see the amount of people who will resort to unverified products sold online because of either embarrassment or lack of insurance," said Dr. Ridwan, "It's even more troubling to see marketers take advantage of these vulnerable consumers just to turn a profit."

Dr. Ridwan advises consumers that when doctors prescribe medication, they factor in all other medications that the patient is taking, "which is why patients should not put their health at risk by either supplements herbal remedies for ED online or take medications that were not specifically prescribed for them," he said. Dr. Ridwan also warned that if a product claims to "work in minutes" or "quickly provides effects for 24 to 72 hours," the product likely contains ingredients or variants that are only in FDA-approved medications. "You get what you pay for," said Dr. Ridwan, "But with these supplements, it's just not worth the risk."

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