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
I don't think they care too much about that over there.
LOL!!!! Well hehehehe I just happen to know a lot about the substitutes without actual experience ;-)
I know. I thought this stuff was being openly marketed HERE after import.
Probably the best-dressed doctor on the staff.
Is that what Clinton tried to inhale?
I'm not sure if this is the same case as the one I read about years ago when they were putting actual chemical drugs into the herbs. There are some herbs that used to make drugs. I know the FDA was whining about red yeast rice though and that was a big to-do.
I did read the whole post, and YOU are couselling some guy that this CRAP, or some other herbal CRAP, does not RAISE the blood pressure as much as Viagra or Levitra.
You have NO idea what you are talking about, despite the fact that you manage some store for your buddy....I'm sure he pays you well if you sell a lot of stuff even if you do not know WTF you are talking about.
The dangers of Viagra and Levitra come from potential medical interactions between those medications and other anti-hypertensives (esp. nitrates) taken by those patients that have significant coronary artery disease. They lower blood pressure, sometimes to a significant degree.
Educate people, do them a service. Ignorance is bliss....or in this case, a sale I guess.
I click on a thread about unsafe impotence pills, scroll down a bit, and find a thread that starts "Horny Goat Weed..."
Of course it was you. [big grin]
Whatever. Enjoy your evening.
And their wives.
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