Dangerous Medicine – RU 486 (11/04)

The Food and Drug Administration's announcement that it will strengthen the warning label for the drug RU-486, known by the brand name Mifeprex and often called the French abortion pill, is a case of too little too late. Three Americans have died (as of Nov 2004) after taking the pill since it was approved, during a heavily politicized process by Congress and the Clinton administration, in September 2000. The new announcement suggests that the FDA still hasn't learned its lesson – and that this drug should be taken off the pharmacy shelves. The story of how RU-486 got approval is buried in 9,300 pages of documents released by the drug agency to the legal watchdog group Judicial Watch, which filed a Freedom of Information Act suit. These documents show that the Clinton administration – which had been warned of the drug's potential hazards as far back as 1995 in a citizen petition filed by Americans United for Life – pushed to get RU-486 approved before the 2000 election despite the lack of reliable data demonstrating its safety. Congress may have been satisfied, but many doctors were not. Some researchers had detailed the dangers of RU-486 – including me, in an article I helped write that appeared in The Annals of Pharmacotherapy in January 2003 – but neither the public nor our elected officials took notice. Then, last September, an 18-year-old named Holly Patterson died after an RU-486 abortion at a Planned Parenthood clinic in CA. An autopsy found that she died of septic shock caused by endomyometritis, an inflammation of the uterus, "due to therapeutic, drug-induced abortion."    ...