Posted on 11/04/2004 4:38:14 PM PST by neverdem
WASHINGTON -- The Food and Drug Administration warned consumers yesterday not to buy or use the supplements Actra-Rx or Yilishen because they contain an ingredient that could lower blood pressure to unsafe levels.
The FDA also moved to block imports of the supplements, calling them "dangerous ... and even life-threatening." The agency said the supplement bears the name Yilishen when it is imported from China and is sold as Actra-Rx within the United States.
Laura Alvey, an FDA spokeswoman, declined further comment, saying the matter is under investigation that may lead to criminal or civil enforcement actions.
When the FDA on March 27, 1998, approved Viagra, the first pill to treat impotence, it warned consumers not to use the drug in combination with products containing nitrates to avoid worrisome lowering of blood pressure. Because people buy Actra-Rx without a doctor's prescription, however, consumers receive no such warning.
Actra-Rx and Yilishen are promoted on Web sites as erectile dysfunction treatments that enhance men's sexual performance, the FDA said.
Despite an all-natural label, Actra-Rx capsules contain prescription strength levels of sildenafil, the active ingredient in Viagra, according to a letter published in the Journal of the American Medical Association.
According to "Sex, Lies and Niagra," published in the Feb. 4, 2004, issue of JAMA, chemical analyses found an average of 55 milligrams of sildenafil per capsule of Actra-Rx and Niagra Actra-Rx, another name under which the product has been sold.
"The use of such non-prescription substances may present health risks for individuals with contraindications to the use of sildenafil," wrote the authors.
Follow up testing by the FDA confirmed Actra-Rx contained prescription-strength levels of sildenafil.
The recommended dose for Viagra, produced by Pfizer, is 50 milligrams. Some men take as little as 25 milligrams or as much as 100 milligrams.
A spokesman for Los Angeles-based Body Basics declined to comment. The company's voice mail identifies them as manufacturer of Actra-Rx. The company's Web site continues to advertise Actra-Rx as a "natural sexual enhancer" available in starter kits of 10 pills for $78.99.
According to the FDA, the sildenafil in Actra-Rx can interact with certain prescription drugs that contain nitrates or nitrates in illicit substances, significantly lowering blood pressure to unsafe levels.
Men at risk include those with diabetes, high blood pressure, high cholesterol or heart disease. Those individuals use medications that contain nitrates and often suffer erectile dysfunction.
The FDA advised people who have taken Actra-Rx or Yilishen to stop using it and to consult a doctor regarding an alternate erectile dysfunction treatment.
Heart pill for black patients
The nation's first ethnic drug -- a pill for black patients with heart failure -- may soon be heading to a pharmacy near you.
The drug, called BiDil, is the brainchild of Dr. Jay Cohn, a heart specialist at the University of Minnesota. And it's being hailed as a major breakthrough for a deadly disease that, some have claimed, strikes blacks at higher rates than others.
But as the drug speeds toward approval, it has run afoul of critics.
Critics such as Jay Kaufman, an epidemiologist at the University of North Carolina, say that it's irresponsible and unscientific to imply that BiDil works better on people of one race than on another.
"There's no evidence that the results for any therapy are significantly different for African Americans," said Kaufman, who studies racial disparities in health care.
Monday, Cohn and his colleague, Dr. Anne Taylor, will unveil the results of a major trial of BiDil, involving more than 1,000 black patients, that could pave the way for approval by the FDA.
For Cohn, it's the culmination of a 30-year struggle to prove that his idea to combine two old drugs -- now repackaged as a single pill called BiDil -- can save lives. At the same time, the research has placed him in the middle of a touchy debate about the role of race in medicine.
The drug's manufacturer, NitroMed Inc., has asked the FDA's approval to market BiDil specifically as a heart drug for blacks.
Cohn believes that the drug also works in whites and other groups. For almost 20 years, he has been giving the generic equivalent to patients without regard to race.
But he agrees that the company had good reasons to pursue BiDil as an ethnic drug. The sponsor chose to test it only in black patients, he said, because earlier studies suggested they were more likely to respond than others.
"We've proved that BiDil is an effective treatment for heart disease," Cohn said. "Now, who is it effective in? In African-Americans, I now know that."
Have a question about health care? Drop us an e-mail at health@seattlepi.com. For a wide variety of health news, go to seattlepi.com/health
© 1998-2004 Seattle Post-Intelligencer
Well it's about time. There's no justification for all these chemical erections. WTF
Whenever you see a supplement touting its health benefits because it's "all natural," just remember: tapeworms and arsenic are "all natural" too.
"There's no justification for all these chemical erections. WTF"
The answer is in the "F".
Hey, one day I may have this problem too, so I can't knock the product.
What about that stuff called "Horney Goat Weed" ?
Seen it forsale in various gas stations and truck stops. Judgin from the name I figured it would be a bad idea..........
Then there is those other things that can give you an erection for over 9 hours or more. Listed on tv in the side effects. Aint no doctor but that don't sound good.
Of course the wife has been hunting up the saltpeter for me but she thinks I'm immune ;-)
FReepmail me if you want on or off my health and science ping list.
Horny Goat Weed is an excellent substitute for viagra as it doesn't raise the blood pressure as much as lovietra (sp?) or viagra. I have a lot of clients who can't take the prescription pills because of high blood pressure and prostate issues but the herbals help them. The problem happens when men think more is better and abuse pills whether they're prescription or not. Having said that, I don't care for chinese herbs other than a select few. I wouldn't order anything from China anyway. It's already been shown that Chinese packaged herbs have had PRESCRIPTION MEDICINE in them already.
I manage a health food store for someone and don't order herbals originating in China at all. One has to be careful. Like prescriptions, they add fake ingredients to everything there.
What are your thoughts on Yohimbe and Maca Root?
Not for guys with high blood pressure... otherwise it's great. I sell a really concentrated blue pill that's supposed to be a herbal knockoff of viagra. However, the pure powder herb not concentrated down into the alkaloid is much much better and not so stimulating. I notice really low quality cheap supplements with ephedra in it but not as much since the crackdown.
By this paragraph, you have shown yourself to be completely ignorant of the topic by your complete and total misunderstanding of the whole medical issues for people with vascular disease with taking medicines like Viagra...
And you give advice to people taking this stuff??
I'm relating my customers' experiences with different products and what their doctors have given them. Sorry if you don't like what I say, but I'm not ignorant. Have a nice evening.
Well, if you think Viagra and Lovitra RAISE blood pressure, then you are ignorant of pharmacology and physiology and the topic in general.
And, I am having a nice evening...thanks for you well wishes.
with a screen name like yours, i can see why you would make such a statement. nonetheless, our medical profession has done an outstanding job of giving the public what it wants in this case...
How does the sildenafil get into it?
If it's a herbal substance in a herb, that's one thing. But if it is chemically purified then the makers of Viagra have the patent and they can litigate it off the market. The FDA would have no part in this matter.
So you go ahead and tell my customers and their doctors that they're being ignorant of their own experiences. Please read the whole post before you launch into your pissing contest about ignorance. I'm not some seven dollar an hour idiot behind a counter. Thanks.
The Chinese manufacturers are infamous for lacing drugs into 'herbal' supplements.
Well that's good enough reason to ban it. Herbal should be herbal, not something from a test tube.
Only you, cyborg. Only you.
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