FDA News

FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
The U.S. Food and Drug Administration today 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 the prevention and treatment of sexually transmitted diseases (STDs). Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.

"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," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs." The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.

Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED). The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.

Issuing these Warning Letters is part of the FDA’s ongoing campaign against fraudulent products marketed on the Internet for serious and life-threatening diseases. The agency also works to educate consumers about the risks and dangers that exist from buying unsafe products. Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
To view the letters, http://www.fda.gov/foi/warning_letters/s6680c.htm - Aviralex Int.
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FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events

Background: On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium. The studies were designed to assess the effectiveness of treatment with Prilosec, or Nexium, or surgery for severe GERD. Participants were randomly assigned to receive treatment with either a drug (Prilosec in one study and Nexium in the other) or surgery. During the studies, cardiovascular events raised a question about whether long-term use of these drugs increases the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the prescribed drugs compared to patients who received surgical treatment. On Aug. 9, 2007 FDA released an "Early Communication of an Ongoing Safety Review" of these drugs. The agency’s initial review determined that there was no increased risk of heart problems associated with long-term use of these drugs. At FDA’s request, AstraZeneca submitted a large amount of additional information about these and other studies and FDA undertook a comprehensive review of all available data regarding this potential safety concern. The following represents the agency’s current analysis of available data on these medications.

Current Information: FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium. While both of the long-term studies reported to FDA on May 29, 2007 collected safety data, the study protocols did not specify how heart problems, such as heart attacks, were defined or verified. As a result, evaluating the information that was gathered about the safety of both drugs in these studies was challenging. FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.

General News Room

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol Products found to contain unauthorized drug. The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.
These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA’s Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

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