FDA approves new label for abortion medication

The FDA has approved a supplemental application from Danco Laboratories that expands the use of Mifeprex, which is indicated for the medical termination of intrauterine pregnancy, according to the company.

Mifeprex (mifepristone), along with misoprostol, was approved for early pregnancy termination in 2000.

The FDA's new approval includes a change in the dose of mifepristone and the dosing regimen of mifepristone and misoprostol, which reflect scientific research and evidence-based practice, according to several medical organizations.

Mifepristone is now approved for use through 70 days gestation; previous labeling had only authorized use through 49 days.

Other changes reduce the dose of mifepristone from 600 mg to 200 mg, reduce the amount of time between administration of mifepristone and misoprostol and reduce the number of visits to health care providers.

Mark S. DeFrancesco, MD, MBA, American Congress of Obstetricians and Gynecologists (ACOG) president, expressed the organization's approval.

"ACOG is pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices, and includes many of the recommendations that ACOG had presented to the agency," he said in a release.

"The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion," DeFrancesco continued. "And by allowing more qualified health care providers to prescribe and administer mifepristone, and removing the in-person follow-up appointment, the updated label will also make medication abortion accessible to more women, including previously underserved and rural women."

He also acknowledged that "there is still more work to do" for the label to most accurately reflect current evidence.

"For example, ACOG believes that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary for mifepristone, given its history of safe use," DeFrancesco said. "The REMS requirement is inconsistent with requirements for other drugs with similar or greater risks, especially in light of the significant benefit that mifepristone provides to patients."