TUESDAY, Feb. 3, 2004 (HealthDayNews) -- The concern about over-the-counter health remedies is often that the products contain no helpful ingredients and customers are plunking down money for nothing.
Researchers in Miami, however, have found something much more disturbing: A "100 percent natural" product sold over the Internet to cure impotence actually contains about 55 milligrams of sildenafil, better known by the brand name Viagra, per capsule.
The effectiveness of the compound may not be in question, but its safety is. Viagra is legally available by prescription only and, according to product information, should not be taken if a person is also taking medications containing nitrates. If the two are combined, blood pressure could plummet, leading, in some instances, to a heart attack or stroke. Nitrates are found in medications used to treat angina as well as in some recreational drugs.
Alberto J. Sabucedo, a faculty member with the International Forensic Research Institute, part of the chemistry department at Florida International University in Miami, first learned that a product called Actra Rx, made by Body Basics, might contain sildenafil. The tip came from a journalism student, Mauricio Gutierrez, at the same university.
Gutierrez had some Niagra Actra Rx capsules, which he asked Sabucedo to analyze via mass spectrometry. A preliminary analysis revealed a compound with the same molecular mass as sildenafil. Sabucedo was worried the sample could have been contaminated, so he went on the company Web site and ordered a bottle to be delivered with documentation via Federal Express. "I kept a chain of custody so no one could tamper with it," Sabucedo explains.
The new product, called Actra Rx (the "Niagra" was covered with tape on the label, Sabucedo says), turned out to contain about 55 milligrams of sildenafil. Pfizer's drug is available in 25-, 50- and 100-milligram tablets.
Sabucedo has outlined his findings in a research letter appearing in the Feb. 4 issue of the Journal of the American Medical Association.
"They claim on the Web site that it's completely safe, that it's natural. They go so far as to say it's OK for diabetics and hypertensive patients, but these are people on medication," Sabucedo says. "Typically, people who are going to use this are very likely to be on medication. There is no warning, no labeling, which the FDA requires."
Frank Estrada, chairman of the board of Body Basics, insists his products do not contain sildenafil. "The manufacturer has unequivocally assured us that Actra-Rx DOES NOT contain sildenafil," he wrote in a letter. He adds that Pfizer Inc., Viagra's maker, sued him two years ago, alleging the product contained sildenafil, but the two parties settled out of court. As part of that settlement, Body Basics is no longer allowed to use the name "Niagra" on its products. Pfizer did not return a call seeking comment.
Estrada also provided a letter from the product manufacturer, Shenyang Changgang Yibao Alcohol Co. Ltd. of China, dated Jan. 30, which starts, "This is to categorically deny that our product 'Yilishen,' also known as ACTRA RX, contains sildenafil. Our ingredients and proprietary formulation are based on natural materials."
The Chinese letter goes on to say, "That our product mimics the profile of sildenafil in analytical procedures is well known to us since its launch."
But Sabucedo says that having a match this close in two different products is virtually impossible. "It's like saying we have two individuals who are not identical twins but who have the same DNA," he says. "We have a fingerprint that matches identically to this one. There's always a chance that it could be something else, but it's very, very remote."
The U.S. Food and Drug Administration says it is investigating both these particular allegations and these types of problems in general. "These kinds of products are of concern to us, and it's something that we're looking at on an ongoing basis," says FDA spokesman Brad Stone. "One of our concerns ... is that it poses a significant risk to patients."
"You cannot put an active drug ingredient without the proper labeling that goes with any drug, because that assures safety," Stone adds.
If an investigation reveals the products do contain active drug ingredients, the FDA "tries to get them off the market as quickly as possible," Stone says. They could do this via seizure or injunction.
Sabucedo has tested four other products that came up negative for sildenafil. He is planning to seek funding to expand his research; the current study did not receive outside monies.
Meanwhile, Estrada points to thousands of customers who have had good effects with Actra Rx that they did not experience with Viagra.
"After testing Niagra I'm very impressed with its effect, which is (for me) better than Viagra," wrote one satisfied customer in an e-mail. "So I'd like to order another 20."
More information
For more on erectile dysfunction, visit the National Institutes of Health or the American Foundation for Urologic Disease.
