FDA Eases Restrictions on Abortion Drug

Mifepristone is now approved for use up to 70 days after the first day of a woman's last menstrual period.

Medical abortions should now be more accessible to women who want them. The FDA this week announced it was changing the label for mifepristone (Mifeprex/Danco Labs), a drug used to induce termination of pregnancy.

The drug is now approved for use up to 70 days after the first day of a woman’s last menstrual period. When the FDA originally approved mifepristone, that window for use was 49 days. The new label also changed the recommended dose, reducing it to 200 mg.

It had been 600 mg, a dosage that many experts had said was too high. The change comes a decade after a March 2006 FDA public health advisory reporting 2 deaths in patients who got the previous recommended regimen of 600 mg on day 1 and 400 mcg of misoprostol on day 3. As of April 2011, there were 14 reported deaths in women who took the drug, but the FDA said they were associated with sepsis in 8 cases and that the others “involved unique events,” including illicit drug overdoses and a suspected homicide.

The new dosing regimen calls for the mifepristone to be followed within 24 to 48 hours by 800 mcg of misoprostol. The National Abortion Rights Action League (NARAL) praised the FDA for the changes, noting the new policy means women can end a pregnancy at up to 10 weeks gestation.

“More than 1 and a half million women have used mifepristone since its FDA approval in the United States with incredibly low risk of an adverse effect. The FDA understands this and is rightfully choosing to side with science instead of politics with today’s changes,” NARAL said in a statement attributed to Ilyse Hogue, President of NARAL Pro-Choice America.

The FDA said the change came in response to a supplemental application by the manufacturer. In issuing the new “risk evaluation and mitigation strategy,” the FDA said there are still safety concerns to be addressed. The drug must be prescribed and dispensed by a healthcare provider who meets certain qualifications.

It may only be dispensed in clinics, medical offices, and hospital by or under the supervision of a certified healthcare provider. That provider has to obtain a signed patient agreement form.