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Delaware Health Alert Network #148

March 12, 2008 10:08 am


Health Advisory
FDA MEDWATCH - UNAPPROVED OVER THE COUNTER DRUGS MARKETED FOR THE PREVENTION AND TREATMENT OF STDS

On March 3, 2008 the Food and Drug Administration issued a press release advising healthcare professionals and consumers that the Agency 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).

The products are marketed under the names Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus and claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS.

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. Consumers who are currently using these products should stop using them immediately and consult their healthcare professional if they have experienced any adverse effects that they suspect are related to the use of these products.

Read the complete 2008 MedWatch Safety Summary, including a link to FDA's News Release regarding this issue at:  http://www.fda.gov/medwatch/safety/2008/safety08.htm#STDs

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.

For additional information about STDs and Centers for Disease Control and Prevention (CDC) recommended treatment, you may contact the Delaware Division of Public Health Sexually Transmitted Disease Program office at 302-744-1050.

Categories of Health Alert messages:

  • Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
  • Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
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