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FDA Warns Consumers on Dangerous Products Promoted on the Internet

United States

FDA is warning consumers not to purchase certain unapproved products that pose significant, possibly life-threatening health risks. The products in question, which are offered for sale on the Internet, are home abortion kits and female self-sterilization kits.
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.




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The Abortion Pill: Mifepristone and Misoprostol for Early Abortion : The Abortion Pill (brand name Mifeprex) is a form of early abortion caused by the combination of two medications, mifepristone and misoprostol. Also known as RU486, mifepristone has been used safely in Europe for many years. The Abortion Pill is an early abortion option for women who are 8 weeks pregnant or less. During the first appointment at the clinic you receive the mifepristone pill to take orally. Then 24 to 72 hours later, in the privacy
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Coalition on Abortion/Breast Cancer : In 1986, government scientists wrote a letter to the British journal Lancet and acknowledged that abortion is a cause of breast cancer. They wrote, "Induced abortion before first term pregnancy increases the risk of breast cancer." As of 2006, eight medical organizations recognize that abortion raises a woman's risk for breast cancer, independently of the risk of delaying the birth of a first child (a secondary effect that all experts alrea
Methotrexate and Misoprostol to Terminate Early Pregnancy : Background Although medical termination of pregnancy is available in Europe and China as an alternative to surgical termination, political and social factors have blocked medical approaches to pregnancy termination in the United States. Methotrexate, which is toxic to trophoblastic tissue, has been used safely to treat unruptured ectopic pregnancies. This report describes the use of a single low dose of methotrexate followed by intravaginal misop
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