Competing medical abortion regimens differ in efficacy

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014

SAN FRANCISCO – The medical abortion regimen approved by the Food and Drug Administration is less effective and less convenient than an alternative evidence-based regimen, yet in some areas women are being denied access to the more effective regimen, Dr. Jody Steinauer said.

Some U.S. states are mandating that only the FDA-approved regimen be offered to women. "That is going to have a real impact on women’s care," she said at a conference on women’s health sponsored by the University of California, San Francisco.

The FDA-approved regimen is 92%-96% effective in causing abortions in pregnancies of less than 49 days, and in 50% of cases the abortion will be complete within 4 hours. The alternative regimen is 96%-99% effective for gestations of less than 63 days, with complete abortions in less than 4 hours in 93% of cases, said Dr. Steinauer of the university.

Sherry Boschert/Frontline Medical News

Two states – Arizona and Ohio – require that the FDA-approved regimen be used when prescribing the progesterone antagonist mifepristone for abortion, according to the Guttmacher Institute, which seeks to advance reproductive rights. Two other states – North Dakota and Oklahoma – passed similar laws that have been stayed by the courts.

Under the FDA-approved regimen, the woman is given 600 mg of mifepristone orally (three tablets of Mifeprex) in the clinic. That’s a higher dose than the 200 mg (one tablet) of mifepristone that has been shown to be effective and is also is taken in the clinic under the alternative regimen, Dr. Steinauer said. In both scenarios, the woman then goes home with pain medications to use as needed.

Two days later, according to the FDA-approved regimen, the woman is given 400 mcg of the prostaglandin misoprostol orally in the clinic to induce bleeding over the next 4-24 hours or more. "In the FDA-approved regimen as modeled by France, women have to pass the pregnancy in the clinic, so you would have to have a place for her to be bleeding," Dr. Steinauer said.

Under the alternative regimen, the woman places 800 mcg of misoprostol pills in the vagina or buccally to induce bleeding, but she can decide to take it anywhere from 6 hours to 3 days after taking the mifepristone and she can take the misoprostol at home. "There’s a lot of flexibility in when women take `miso,’ so they can decide when they will have bleeding," which can happen at home, she said.

The vaginal or buccal administration of misoprostol in the alternative regimen is "much more effective" than oral administration, she added.

The FDA regimen calls for follow-up on day 14. The alternative regimen again is more flexible, allowing follow-up in the range of days 3-14. The FDA says that the approved regimen can be used for gestations up to 7 weeks, while the gestational limit for the alternative regimen is 9 weeks.

Dr. Steinauer’s institution follows the alternative regimen. Patients may return for follow-up as soon as 3 days after taking the misoprostol, and they are instructed to call earlier if they experience unexpected symptoms.

Both the FDA regimen and the alternative regimen are safe, "and, given the higher efficacy of the evidence-based regimen," it might be safer than the FDA-approved one, she said.

On average, the alternative regimen is 97% effective, with incomplete abortion in 2% and continuing pregnancy in 1%, Dr. Steinauer said.

Studies on side effects from medical abortions show bleeding longer than 30 days in 9% of cases, bleeding before misoprostol (after mifepristone) in 21%-47%, abdominal pain requiring narcotics in 29%-73%, nausea in 20%-65%, vomiting in 10%-44%, diarrhea in 3%-29%, chills or fever in 7%-44%, headache in 27%-32%, dizziness in 12%-38%, and passage of the pregnancy before misoprostol in 4%, she said.

When asked to comment on the comparison of regimens, Dr. Eve Espey said that fewer side effects are seen with buccal or vaginal administration of misoprostol compared with taking the drug orally, and that the lower dose of mifepristone in the alternative regimen also may reduce side effects.

The comparison of regimens "is useful to clinicians who may be confused about the legal challenges to the ‘alternative’ or ‘evidence-based’ medical abortion regimen. Dr. Steinauer highlights the superiority of the alternative regimen: it uses less medication, making it less expensive with fewer side effects, and offers a more convenient schedule with fewer total visits for the patient," said Dr. Espey, an ob.gyn. at the University of New Mexico, Albuquerque. "Legal restrictions on the alternative medical abortion regimen are non–evidence based and are harmful to women."

When asked why the alternative regimen has not been reviewed by the FDA, an FDA spokeswoman responded in an e-mail, “The Agency reviews applications for changes to approved applications that are submitted by drug manufacturers.” The FDA cannot comment on whether or not it has received an application, added Andrea Fischer of the FDA’s Office of Media Affairs.

When asked to comment on moves by some politicians to restrict medical abortions to the FDA-approved regimen, she wrote, “FDA works to ensure that approved products are appropriately labeled based on data submitted in applications for the drugs’ approvals; this provides health care practitioners with accurate information about the safety and effectiveness data supporting each approval.”*

Dr. Steinauer and Dr. Espey reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

* This story was updated 1/27/2014