There are still many questions as to what is the exact role of RU-486 in these deaths and our office is doing its part to help investigate the matter. Here is what we know regarding the public medical concern and debate regarding RU-486.
On September 28, 2000 the FDA approved the drug Mifeprex, also known as RU-486 to terminate pregnancies of less than eight weeks. Mifeprex is a combination of two medications: mifepristone and misoprostol. During the woman’s first appointment she orally takes mifepristone. This drug blocks the hormone progesterone causing the uterine lining to shed. Next the cervix begins to soften, which may result in bleeding. Then, according to the FDA approved protocol, 24 to 72 hours later the woman is administered misoprostol orally. Recently the FDA made it a point to notify physicians and the public that the approved regimen for misoprostol calls for oral administration only, although many providers continued to prescribe misoprostol vaginally. The Misoprostol induces contractions resulting in a miscarriage.
On July 19, 2005, the FDA issued a public health advisory warning, regarding the risks of death, infection and other complications linked to RU-486. Both the FDA and Danco Laboratories have updated warnings provided to patients and health care professionals as a result of the reported infections and deaths.
It is likely that more people have been injured as a result of using RU-486 than have been reported in the media. Our office continues to accept information from individuals who believe they or their loved ones have been harmed as a result of taking RU-486. To fill out an intake form click here.