FDA warns of abortion, sterilization kits on Net

Warn your patients to stay away from home abortion kits and female self-sterilization kits offered for sale on the Internet. The Food and Drug Administration (FDA) has issued a statement on the dangers of these two products, both of which carry significant safety risks.1

The agency conducted a health hazard assessment of the method and says the home abortion kit includes drugs that, used 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 the kit’s drugs, the FDA notes.

"The abortion kit inaccurately touts itself as a ‘complete kit for early pregnancy termination without surgery . . . scientifically proved safe and unrisky,’" states an FDA "talk paper" on the subject. "The kit provides a combination of drugs that are not approved by FDA to terminate pregnancy."

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 FDA states. 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.

Clinicians who have treated women for adverse reactions to these kits are asked to contact the agency’s Medwatch adverse event and product problem hot line at (800) FDA-1088.

Reference

1. Food and Drug Administration. FDA warns consumers on dangerous products promoted on the Internet. FDA Talk Paper; June 17, 1997.