Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.
Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals.
"It's pretty scary stuff," said Neil Campbell, the lead author of the study and a researcher at Pfizer, which sells Viagra. "These products are not herbal at all, they're adulterated."
The U.S. Food and Drug Administration, which is in charge of regulating herbal supplements, posted 11 warnings to consumers in 2013 alerting them of unlabeled pharmaceuticals being found in these products.
Campbell and his colleagues analyzed 91 samples from 58 products.
They sent undercover consumers into convenience stores and gas stations in the Atlanta and Baltimore areas, and bought products such as Rize 2 The Occasion, Stiff 4 Hours, and Man King.
Although 57 of the products claimed to be "all natural," 81 percent of them contained the tadalafil or sildenafil (marketed as Cialis and Viagra, respectively) or similar ingredients that are not approved by the FDA.
The products also had labeling problems, indicating poor quality production, according to the authors. In some cases, expiration dates or lot numbers were missing, manufacturers could not be identified, or samples of the same product had different appearances.
"There's so little effort to do something the right way to produce a legitimate product," Campbell told Reuters Health. "This is an all time low."
None of 10 supplement companies contacted by Reuters Health responded to a request for comment, nor did the FDA.
Campbell said given the potential side effects and health risks associated with prescription erectile dysfunction drugs, men are "risking their lives" taking herbal sex enhancement drugs.
"Almost one patient a day says they've tried Mojo or one of these over-the-counter products," said Dr. Gregory Lowe, an assistant professor of urology at Ohio State University who was not part of this study.
"One of the big concerns is that we don't know what the patient's getting," he added.
Seven samples that Campbell's group analyzed contained only unknown substances.
"Commonly, I hear patients say, 'it worked one time and it didn't work other times.' And that fits in well with what they found here" that quality control is lacking, he added.
It's unclear where the ingredients are coming from.
Lowe advises men who are interested in taking these pills to talk to their doctors first.
He says patients often turn to these products because they are cheap - costing between $2.99 and $17.99, according to Campbell's study, published in the Journal of Sexual Medicine.
But they are taking a health risk in doing so.
Erectile dysfunction medicines can be unsafe for men taking nitrates for chest pain, but only 14 of the samples in the study included a warning against combining the drugs.
"Unfortunately, to an unwitting patient they think they're taking an herbal product," said Campbell. "It really poses a really scary threat for patient health and safety."
SOURCE: http://bit.ly/17KGjiu Journal of Sexual Medicine, online May 1, 2013.
Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals."It's pretty scary stuff," said Neil Campbell, the lead author of the study and a researcher at Pfizer, which sells Viagra. "These products are not herbal at all, they're adulterated."
The U.S. Food and Drug Administration, which is in charge of regulating herbal supplements, posted 11 warnings to consumers in 2013 alerting them of unlabeled pharmaceuticals being found in these products.
Campbell and his colleagues analyzed 91 samples from 58 products.
They sent undercover consumers into convenience stores and gas stations in the Atlanta and Baltimore areas, and bought products such as Rize 2 The Occasion, Stiff 4 Hours, and Man King.
Although 57 of the products claimed to be "all natural," 81 percent of them contained the tadalafil or sildenafil (marketed as Cialis and Viagra, respectively) or similar ingredients that are not approved by the FDA.
The products also had labeling problems, indicating poor quality production, according to the authors. In some cases, expiration dates or lot numbers were missing, manufacturers could not be identified, or samples of the same product had different appearances.
"There's so little effort to do something the right way to produce a legitimate product," Campbell told Reuters Health. "This is an all time low."
None of 10 supplement companies contacted by Reuters Health responded to a request for comment, nor did the FDA.
Campbell said given the potential side effects and health risks associated with prescription erectile dysfunction drugs, men are "risking their lives" taking herbal sex enhancement drugs.
"Almost one patient a day says they've tried Mojo or one of these over-the-counter products," said Dr. Gregory Lowe, an assistant professor of urology at Ohio State University who was not part of this study.
"One of the big concerns is that we don't know what the patient's getting," he added.
Seven samples that Campbell's group analyzed contained only unknown substances.
"Commonly, I hear patients say, 'it worked one time and it didn't work other times.' And that fits in well with what they found here" that quality control is lacking, he added.
It's unclear where the ingredients are coming from.
Lowe advises men who are interested in taking these pills to talk to their doctors first.
He says patients often turn to these products because they are cheap - costing between $2.99 and $17.99, according to Campbell's study, published in the Journal of Sexual Medicine.
But they are taking a health risk in doing so.
Erectile dysfunction medicines can be unsafe for men taking nitrates for chest pain, but only 14 of the samples in the study included a warning against combining the drugs.
"Unfortunately, to an unwitting patient they think they're taking an herbal product," said Campbell. "It really poses a really scary threat for patient health and safety."
SOURCE: http://bit.ly/17KGjiu Journal of Sexual Medicine, online May 1, 2013.
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