FDA Investigating Holly Patterson’s RU 486 Abortion Death
by Steven Ertelt
October 6, 2003
Washington, DC (LifeNews.com) — Following the death of a California teenager who died after taking the RU 486 abortion drug, the Food and Drug Administration announced that it would be conducting an investigation.
White House press secretary Scott McClellan said, "The FDA is currently reviewing all the facts of this case to determine if any action is needed."
McClellan added, "The president has always expressed his concern that what’s most important is the safety of women, and that continues to be a priority for him."
Pro-life groups say a thorough investigation into the risks and dangers associated with the drug should have taken place before it was approved by the Clinton administration in September 2000.
In August 2002, a citizen petition was filed by pro-life groups asking the FDA to revoke its approval of mifepristone (RU 486) on grounds it jeopardizes the health and safety of women.
An FDA spokesperson said the request, filed by the American Association of Pro-Life Obstetrics and Gynecologists, the Christian Medical Association and Concerned Women for America, is still under review.
The drug’s manufacturer, Danco Laboratories, has filed a response designed to mitigate FDA action
The Christian Medical Association said the rushed approval of the abortion pill has "put American women and teenagers at dire risk."
"We filed a petition with the FDA over a year ago to help avoid precisely the kind of preventable tragedy that may prove to have taken the life of this young woman," said Dr. Gene Rudd, Associate Executive Director of the CMA.
"We are concerned that some FDA officials buckled to political pressure in approving the drug in September 2000. As our Freedom of Information Act requests and petition to the FDA reveal, that decision to allow an unsafe drug regimen appeared to have been driven more by political pressure than safety and science," Rudd added.
The 90-page "citizen petition" notes that RU-486 trials used in securing FDA approval were not blinded, randomized, or concurrently controlled. The FDA also inexplicably waived its rule requiring the testing of all new drugs for their potential effects on children and teenagers
The hospital that treated Patterson before her death is also encouraging the FDA to review the abortion drug.
"A request for (FDA) review was made over a year ago and we’re saying, review it," said ValleyCare Hospital board Chairman David Mertes.
Danco, the distributor of the drug, has reported 400 complications to the FDA since RU-486 received U.S. approval. These include one woman who died from an ectopic pregnancy, another who suffered a heart attack, and two 15-year olds who contracted life-threatening infections. Another woman in Canada died from a bacterial infection.
"Unless the FDA acts now to recall the drug pending a safety review, women are at serious risk of falling victim to a lax drug regimen that stresses access at the expense of medical safety," CMA’s Rudd concluded.
Related web sites:
Christian Medical Association’s RU 486 Petition – https://www.cmdahome.org/index.cgi?CONTEXT=art&art=2106&BISKIT=3954961180