Be on the lookout for Internet STD drugs
Be on the lookout for Internet STD drugs
Talk with your patients about fraudulent drugs sold over the Internet as treatment for sexually transmitted diseases (STDs). The Food and Drug Administration (FDA) has issued warning letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for STD prevention and treatment.
The products, sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus, are marketed over the Internet. Some of those products falsely claim to have FDA approval, while others claim to be more effective than conventional therapies.
The products claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papillomavirus (HPV), cervical dysplasia, and HIV/AIDS. Claims made by the companies range from "greatest STD protection without condoms" (SlicPlus) to "the active ingredient in our product is FDA-certified to destroy 99.9992% of all pathogenic organisms [i.e.,] Chlamydia" (OXi-MED)."
According to an FDA statement on the warning letters, the agency considers these products to be unapproved new drugs which are being marketed in violation of the Food, Drug, and Cosmetic Act. The drugs also are considered as misbranded because they lack proper directions for use by consumers and/or because they make false and misleading claims.
In the FDA statement, Janet Woodcock, MD, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA's Center for Drug Evaluation and Research, said, "The products pose a serious health threat to unsuspecting consumers who don't know that these products are not FDA-approved and have not been proven safe or effective. STDs are very serious diseases, and these products give consumers a false sense of security that they are protected from STDs."
If you or your patients have any complaints or problems associated with those products, notify MedWatch, the FDA's voluntary reporting program. Contact the program by calling toll-free (800) 332-1088, or visit its web page, www.fda.gov/medwatch/report.htm.
Talk with your patients about fraudulent drugs sold over the Internet as treatment for sexually transmitted diseases (STDs). The Food and Drug Administration (FDA) has issued warning letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for STD prevention and treatment.Subscribe Now for Access
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