GAO Finds Mixed Views on FDA Monitoring of Abortion Pill

Posted 29 March 2018 | By Ana Mulero 

GAO Finds Mixed Views on FDA Monitoring of Abortion Pill

Following changes to the dosing and indication for the abortion drug Mifeprex (mifepristone), the US Government Accountability Office (GAO) found mixed views among stakeholder organizations on how its safety is being monitored as thousands of adverse event reports have been associated with its use.

GAO’s report, issued Wednesday, highlights some concerns as well as positive comments on the US Food and Drug Administration’s (FDA) monitoring activities based on a requested review of Mifeprex’s relabeling, approved in 2016 in support of lower doses – from the 600mg approved in 2000 vs. 200mg – and a 3-week extension in the amount of time that it can be used after a woman’s last menstruation.

The gestational limit went from 49 days to up to 70 days. Also the new labeling “no longer requires patients to have a second visit with a health care provider,” according to GAO, which cited this as one of the safety concerns identified during its review.

“We found that FDA has not identified any significant concerns with the safety and use of Mifeprex through its monitoring activities,” GAO said. “However, stakeholder groups had mixed reviews – some said FDA is appropriately monitoring Mifeprex, while others said that FDA may not be aware of all adverse events associated with the drug.”

From 28 September 2000 through 30 June 2017, about 4,200 adverse events and 20 deaths have been associated with the use of Mifeprex and identified by FDA. The report adds: “FDA learned of 2 additional deaths associated with Mifeprex since June 30, 2017.”  Yet some of the reviewed comments stated that “the mortality rate associated with Mifeprex is extremely low.”

Categories: Regulatory News

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