FDA TALK PAPER

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T97-26                                         Brad Stone: (301) 443-3285

June 17, 1997                                  

                                               Consumer Hotline/Laura Alvey: (800) 532-4440  

 

FDA Warns Consumers on
Dangerous Products Promoted on the Internet

The abortion kit inaccurately touts itself as a "complete kit for early pregnancy termination without surgery...scientifically proved safe and unrisky." The kit provides a combination of drugs that are not approved by FDA to terminate pregnancy. The agency conducted a health hazard assessment of this product and concluded that using the kit without a physician's supervision could cause heavy vaginal bleeding and even death. Birth defects also can result if a pregnancy is carried to term after taking these drugs.

The self sterilization kit claims to use a method similar to inserting an IUD and to have a much lower risk than that associated with surgical sterilization. The kit uses pellets of quinacrine hydrochloride, an unapproved drug, which can cause ectopic pregnancy, abnormal pregnancies, and permanent damage to a woman's reproductive organs.

FDA urges consumers not to purchase or use these or similar products promoted via Internet or any other media. The Federal Food, Drug, and Cosmetic Act prohibits the sale and promotion of unapproved medical products. The agency is continuing to investigate and monitor these products.

Consumers who have suffered an adverse event as a result of using these "kits" and health professionals who have treated such patients are asked to report the event to the agency's Medwatch adverse event and product problem hot line at 1-800-FDA-1088.

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