FDA on Monday announced that it will revise the "black box" warning for Danco Laboratories' Mifeprex, a drug taken to induce a medical abortion, in response to numerous reports of infection, bleeding and death among women who have taken the drug, the San Francisco Chronicle reports (Hall, San Francisco Chronicle, 11/16). FDA approved Mifeprex, which is known generically as mifepristone, in 2000 for the termination of early pregnancy, which is defined as 49 days or less (FDA release, 11/15). Although the drug's packaging already included a warning, the new warning is given "added prominence" and urges doctors to "redouble efforts" to monitor women taking the drug for signs of systemic bacterial infections, excessive vaginal bleeding and ectopic pregnancy, according to the New York Times (Harris, New York Times, 11/16). Although such risks are rare, by updating the labeling and Medication Guide information, FDA is providing the most up-to-date information on the drug to the public, according to an FDA release (FDA release, 11/15). The new warning also advises women who have taken the drug to see a health care provider immediately if they experience abdominal pain, fever or heavy bleeding, according to the Chronicle (San Francisco Chronicle, 11/16).

Reason for Changes
Danco spokesperson Cynthia Summers said that the company "voluntarily" changed the warning label, adding, "Danco decided to update the boxed warning to provide information about the most serious risks that can occur following Mifeprex use and to provide information to health care providers and patients about what to do if patients experience very rare but serious problems" (Kerr, Long Island Newsday, 11/16). FDA Acting Commissioner Lester Crawford said that the new warning was issued because the drug's label "needed updating" after reports of deaths linked to the drug, the Wall Street Journal reports. "We believe that physicians may not be as aware as they might be that these infections can occur without the usual signs," Crawford said (Wall Street Journal, 11/16). Crawford said that abortion politics played "no role" in FDA's decision, adding, "We received no political direction or counseling whatsoever" from the White House (New York Times, 11/16).

Deaths Following Mifeprex Use
FDA made no mention of any particular case that caused the agency to issue the new warning, instead saying that the agency has received 676 reports of "adverse events" from women who used the drug, including two deaths from bacterial infections (San Francisco Chronicle, 11/16). In one case, 18-year-old Holly Patterson of Livermore, Calif., died on Sept. 17, 2003, after taking mifepristone that she received one week earlier at a Planned Parenthood clinic in Hayward, Calif., according to her father. It is not known if Patterson also took misoprostol, a drug administered in conjunction with mifepristone to complete a medical abortion. The Alameda County, Calif., Coroner's Office in a preliminary autopsy report in October 2003 concluded that Patterson died of septic shock "due to endomyometritis (inflammation) due to therapeutic, drug-induced abortion." However, the report did not say that the inflammation was caused by mifepristone or whether the drug was properly administered (Kaiser Daily Reproductive Health Report, 8/20). Another woman died in January 2004 after taking Mifeprex, but the death was not reported to FDA until August because of confusion about what drug she had taken before her death, the Chronicle reports (San Francisco Chronicle, 11/16).

Reaction
Holly Patterson's father, Monty Patterson, said that his daughter might still be alive if the new warning label had been in place when she took mifepristone, according to the Chronicle. "I think Holly would have been able to recognize her symptoms early on," Patterson said. He added that he believes the warning label is a "move in the right direction," saying, "I think (the drug) should be banned, but I am glad the FDA did take this first step" (San Francisco Chronicle, 11/16). However, Concerned Women for America "blasted" FDA for not removing the drug from the market, according to the AP/Boston Globe. "Another woman has died after taking the abortion drug [mifepristone], and the FDA's response is to change the drug's label," Wendy Wright, senior policy director for CWA, said, adding, "This is a dangerous drug that deserves to be pulled off the market immediately" (AP/Boston Globe, 11/16). Venessa Cullins, vice president for medical affairs for Planned Parenthood Federation of America, said her group "supports" the new labeling, adding that it is "based on the best scientific information available" (PPFA release, 11/15).