Abortion Pill Deaths
Abortion Pill Death (News 8, Richmond)
There’s controversy surrounding the abortion pill RU-486 following the death of a California teen who took the medication. 18-year-old Holly Patterson is believed to have suffered fatal side effects from the pill. She’s the third woman to die after taking RU-486 but the FDA hasn’t definitively tied any deaths to the use of the pill. The government maintains the pill is safe enough to stay on the market. RU-486 already carries a black label box, the FDA’s most serious warning.
Reports of three deaths and 600 cases of problems such as excessive bleeding and infections in women who took RU-486, the so-called abortion pill, have led to new, stronger warnings on its label, a Food and Drug Administration official said Tuesday. “We don’t have information to indicate that the drug caused the event,” Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said at a news conference. Galson noted that such complications also can occur in women who have had surgical abortions or given birth.
Critics had accused Galson of bowing to political pressure earlier this year when he went against an FDA advisory committee’s recommendation and refused to make emergency contraception Ã¢€” which prevents pregnancy after unprotected sex Ã¢€” available over the counter. Galson, who had defended that decision, said the move to strengthen warnings on the abortion pill also was science-based. “There was absolutely no political pressure on this,” he said.
In a statement, the Planned Parenthood Federation of America, whose clinics provide RU-486, said it supports the updated labeling “because it is based on the best scientific information available.”
RU-486, sold in the USA as Mifeprex, has carried a “black box” warning Ã¢€” the strongest type of label warning Ã¢€” and a consumer-friendly medication guide ever since it came on the market in late 2000. Along with the label, the guide has been updated to include new information about the rare but serious risks. The new label and guide list the warning signs of infection Ã¢€” such as a sustained fever of 100.4 degrees or higher and pelvic tenderness Ã¢€” that require medical attention. While some vaginal bleeding is to be expected, an excessive amount may require prompt treatment or it could lead to shock.
Mifeprex is not effective for ending ectopic, or tubal, pregnancy, but it is sometimes difficult to distinguish this condition from a normal pregnancy. The label and medication guide now warn that severe abdominal pain could be caused by an ectopic pregnancy, not the abortion. The first U.S. woman reported to have died after taking Mifeprex had an undiagnosed ectopic pregnancy but refused to go to the emergency department for treatment, Galson said.
If even Planned Parenthood supports the warning labels, the health hazards must be serious indeed.