FDA updates labeling for mifepristone for early abortions

The Food and Drug Administration has approved new labeling for the early abortion drug mifepristone, which women’s health advocates say now puts it in line with current medical standards.

Under the revised labeling, the FDA has approved the use of mifepristone (Mifeprex) in combination with misoprostol, to end a pregnancy through 70 days’ gestation. On the first day of the new regimen, 200 mg of mifepristone is taken orally. Then, 24-48 hours later, women should take 800 mcg of misoprostol buccally (in the cheek pouch). About 7-14 days after taking mifepristone, the FDA recommends that women follow up with their health care provider.

This is the first labeling change since the agency first approved mifepristone in 2000.

Previously, the FDA labeling information had stated that mifepristone was indicated for medication abortion through 49 days of gestation. On day 1, they recommended a 600-mg oral dose of mifepristone, followed by 400 mcg of misoprostol orally 2 days later. The FDA label also previously called for a follow-up office visit about 14 days after the administration of mifepristone.

The FDA is continuing to require a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but they are expanding the types of providers who can prescribe the drug beyond just physicians.

The American Congress of Obstetricians and Gynecologists praised the move, saying that the updated labeling reflects the current available scientific evidence and best practices, including many of ACOG’s own recommendations.

“The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion,” Dr. Mark S. DeFrancesco, ACOG president, said in a statement. “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.”

But he said that more work is needed. For example, ACOG wants the FDA to eliminate the REMS requirements, noting that they are no longer necessary given the history of safe use of the drug.

Dr. Carolyn Westhoff, senior medical adviser for the Planned Parenthood Federation of America, said the FDA’s revised labeling won’t affect the majority of women seeking medication abortion, since most abortion providers around the country – including Planned Parenthood affiliates – have been using a different medication abortion regimen for about a decade.

But the change will make a difference in Texas, Ohio, and North Dakota, where state legislators have enacted laws requiring abortion providers to follow the FDA’s 2000 labeling, despite objections by physician groups that the regimen in the original labeling was outdated and potentially less effective. Similar restrictions had been enacted in Arizona, Arkansas, and Oklahoma but have been blocked by the courts.

While those laws will stay on the books, physicians will now be free to follow the most recent labeling from the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The Food and Drug Administration has approved new labeling for the early abortion drug mifepristone, which women’s health advocates say now puts it in line with current medical standards.

Under the revised labeling, the FDA has approved the use of mifepristone (Mifeprex) in combination with misoprostol, to end a pregnancy through 70 days’ gestation. On the first day of the new regimen, 200 mg of mifepristone is taken orally. Then, 24-48 hours later, women should take 800 mcg of misoprostol buccally (in the cheek pouch). About 7-14 days after taking mifepristone, the FDA recommends that women follow up with their health care provider.

This is the first labeling change since the agency first approved mifepristone in 2000.

Previously, the FDA labeling information had stated that mifepristone was indicated for medication abortion through 49 days of gestation. On day 1, they recommended a 600-mg oral dose of mifepristone, followed by 400 mcg of misoprostol orally 2 days later. The FDA label also previously called for a follow-up office visit about 14 days after the administration of mifepristone.

The FDA is continuing to require a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but they are expanding the types of providers who can prescribe the drug beyond just physicians.

The American Congress of Obstetricians and Gynecologists praised the move, saying that the updated labeling reflects the current available scientific evidence and best practices, including many of ACOG’s own recommendations.

“The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion,” Dr. Mark S. DeFrancesco, ACOG president, said in a statement. “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.”

But he said that more work is needed. For example, ACOG wants the FDA to eliminate the REMS requirements, noting that they are no longer necessary given the history of safe use of the drug.

Dr. Carolyn Westhoff, senior medical adviser for the Planned Parenthood Federation of America, said the FDA’s revised labeling won’t affect the majority of women seeking medication abortion, since most abortion providers around the country – including Planned Parenthood affiliates – have been using a different medication abortion regimen for about a decade.

But the change will make a difference in Texas, Ohio, and North Dakota, where state legislators have enacted laws requiring abortion providers to follow the FDA’s 2000 labeling, despite objections by physician groups that the regimen in the original labeling was outdated and potentially less effective. Similar restrictions had been enacted in Arizona, Arkansas, and Oklahoma but have been blocked by the courts.

While those laws will stay on the books, physicians will now be free to follow the most recent labeling from the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny

The Food and Drug Administration has approved new labeling for the early abortion drug mifepristone, which women’s health advocates say now puts it in line with current medical standards.

Under the revised labeling, the FDA has approved the use of mifepristone (Mifeprex) in combination with misoprostol, to end a pregnancy through 70 days’ gestation. On the first day of the new regimen, 200 mg of mifepristone is taken orally. Then, 24-48 hours later, women should take 800 mcg of misoprostol buccally (in the cheek pouch). About 7-14 days after taking mifepristone, the FDA recommends that women follow up with their health care provider.

This is the first labeling change since the agency first approved mifepristone in 2000.

Previously, the FDA labeling information had stated that mifepristone was indicated for medication abortion through 49 days of gestation. On day 1, they recommended a 600-mg oral dose of mifepristone, followed by 400 mcg of misoprostol orally 2 days later. The FDA label also previously called for a follow-up office visit about 14 days after the administration of mifepristone.

The FDA is continuing to require a Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, but they are expanding the types of providers who can prescribe the drug beyond just physicians.

The American Congress of Obstetricians and Gynecologists praised the move, saying that the updated labeling reflects the current available scientific evidence and best practices, including many of ACOG’s own recommendations.

“The evidence-based regimen for medication abortion has been shown to improve efficacy, reduce adverse effects, and even lower the cost of medication abortion,” Dr. Mark S. DeFrancesco, ACOG president, said in a statement. “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.”

But he said that more work is needed. For example, ACOG wants the FDA to eliminate the REMS requirements, noting that they are no longer necessary given the history of safe use of the drug.

Dr. Carolyn Westhoff, senior medical adviser for the Planned Parenthood Federation of America, said the FDA’s revised labeling won’t affect the majority of women seeking medication abortion, since most abortion providers around the country – including Planned Parenthood affiliates – have been using a different medication abortion regimen for about a decade.

But the change will make a difference in Texas, Ohio, and North Dakota, where state legislators have enacted laws requiring abortion providers to follow the FDA’s 2000 labeling, despite objections by physician groups that the regimen in the original labeling was outdated and potentially less effective. Similar restrictions had been enacted in Arizona, Arkansas, and Oklahoma but have been blocked by the courts.

While those laws will stay on the books, physicians will now be free to follow the most recent labeling from the FDA.

mschneider@frontlinemedcom.com

On Twitter @maryellenny