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FDA Investigating Two Deaths from Abortion Pill

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FDA Investigating Two Deaths from Abortion Pill

Health Care

FDA Investigating Two Deaths from Abortion Pill

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The Food and Drug Administration says it is investigating two more deaths of women in the United States who used the abortion pill RU-486. In the wake of the FDA's announcement, Planned Parenthood announced that it would change the way it administers drug-induced abortions, and abortion opponents are stepping up their calls for the drug to be pulled from the market. NPR's Julie Rovner has more.

JULIE ROVNER reporting:

The latest reports bring to seven the number of reported deaths following medical abortions; that's out of more than half a million performed since the pill was approved almost six years ago. It's not clear what caused the latest two, but four of the five earlier deaths, all women in California, were the result of a rare bacterial infection, and in those four cases, the second drug in the two-drug regimen was given to the women vaginally rather than by having them swallow it.

Unidentified Woman (FDA Spokeswoman): All four cases were women who had received this treatment vaginally, who then all quickly reported back to their physician with very serious rapidly spreading infection which led to sepsis and death, unfortunately.

ROVNER: That's a spokeswoman for the FDA. The Agency is asking that its spokespeople not be identified by name for personal safety reasons because of previous threats to FDA staff. Last fall the FDA reminded doctors that vaginal use of the second drug, called misoprostol, is not what the agency formally approved. It's supposed to be taken by mouth and yesterday the agency repeated that directive. The spokeswoman said...

Unidentified Woman: We felt it was urgent to reiterate yet again what is the only approved method for safe administration of RU-486: oral administration followed carefully by their physician with follow up occurring on Day 14.

ROVNER: Vanessa Collins, Vice President for Medical Affairs for the Planned Parenthood Federation of America, says there was good reason for vaginal use its clinics had been recommending.

Dr. VANESSA CULLINS (Vice President, Medical Affairs for the Planned Parenthood Federation of America): The vaginal route has less side effects and it also enables women to have medication abortion procedures up to 63 days as opposed to the 49 days that the oral route is approved for.

ROVNER: But as of yesterday, Cullins said Planned Parenthood has banned vaginal administration of misoprostol in its clinics.

CULLINS: We're making this change because we are being very cautious. The health and safety of our patients is Planned Parenthood's top priority.

ROVNER: Cullins stressed that Planned Parenthood will still offer medical abortion with misoprostol taken orally. And she said that even with the risks, medical abortion remains far safer than carrying a pregnancy to term. But abortion opponents disagree. They've been pushing a bill in Congress that would withdraw approval of RU-486 pending a new safety review. New Jersey Republican Congressman Chris Smith contends that deaths from the drug are being under-reported.

Senator CHRIS SMITH (Republican, New Jersey): It's being listed as sepsis or some other infection. In the case of California, we might not have caught that if the coroners weren't on the ball about the very serious problems of RU-486, which is just another baby pesticide that's being used.

ROVNER: The FDA says it will release details about the circumstances of the latest deaths as soon as it receives them.

Julie Rovner, NPR News, Washington.

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