FDA Strengthens Warning on Mifepristone
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).
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). 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).