The U.S. Food and Drug Administration announced Tuesday that it has sent warning letters to more than a dozen companies that sell non-prescription products that claim to clear up sexual infections.
Among the products targeted are: Herpaflor, Medavir, Viruxo, ImmuneGlory and C-Cure.
U.S. law requires that all products that claim to treat a disease undergo review by federal scientists. The FDA says said none of the products they've targetted in this crackdown have done so. In fact, there are no FDA-approved products or dietary supplements available over-the-counter that can cure or treat sexually transmitted infections (STIs).
And condoms are the only products cleared by FDA to help prevent STIs.
Not only are the products targeted in this crackdown unproven, they could actually be harmful because they could cause infected patients to delay seeking medical care.
"If you aren't treating your STD with an FDA-approved medication, you're not just putting your own health at risk -- you could be endangering your partner," added internist Dr. Debbie Birnkrant in an FDA statement.
Sexual infections are not just bothersome; they can be dangerous. Left untreated, some can lead to scarring of the reproductive organs and infertility.
"These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," Deborah Autor, FDA's director of drug compliance, said in a statement.
Many sexually transmitted infections can be cured with antibiotics, while other infections like herpes and the more serious HIV are incurable, but can be managed with antiviral and antiretroviral therapy.
Many of the websites selling these products appeal to patients who are too embarrassed to go see their doctors, or who are looking for "natural" or alternative therapies.
The website for Viruxo, for example, claims the product is a "cure" and that it contains "14 synergistic ingredients" that will boost the user's immune system and ensure that users never have another outbreak again.
Further down on the site though, written in small print, is this disclaimer: "Statements expressed within this site have not been evaluated by the Food and Drug Administration. Any and all information and/or statements found within this site are for educational purposes only and are NOT intended to diagnose, treat, cure, prevent disease or replace the advice of a licensed healthcare practitioner."
The FDA says such sites are deceiving and are in violation of the Federal Trade Commission Act because they make scientifically unsupported claims about their products ability to prevent or cure STIs.
The FDA is giving the companies 15 days to take their products off the market. If they do not, the agency can take legal action, including seizing products and taking company officials to court.
Dr. Birnkrant says in the FDA statement that people who are sexually active, have had unprotected sex, or think they have been exposed to a sexually transmitted disease should get medical attention if they develop any of these symptoms:
- burning sensation with urination
- pelvic pain
- discharge from the penis or vagina
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