Women Seeking Oral Contraceptives Have Few Contraindications

PHILADELPHIA – About 1,000 St. Louis women who sought combined hormonal contraception as part of a research study had a 2.4% prevalence of a true medical contraindication for this form of contraception.

"This low prevalence supports provision of combined hormonal contraception without a prescription," concluded Hanna Xu and her associates in a poster at the meeting.

The finding may add impetus to an 8-year old project aimed at making at least some type of oral contraception available to U.S. women on an over-the-counter (OTC) basis, commented physicians involved in this effort.

©Tina Sbrigato/iStockphoto.com

"I’m pleased to see a 2.4% rate. It’s actually a bit lower than what we’ve seen in other studies," commented Dr. Anne E. Burke, an ob.gyn. at Johns Hopkins University, Baltimore. "This kind of information is important because it gets at one of the big barriers; data like this reassure us that OTC oral contraceptives are safe," she said in an interview.

Results from other studies have generally shown a higher contraindication prevalence. For example, a 2007 report based on data collected in the National Health and Nutrition Examination Survey (NHANES) 1999-2001 found a 16% prevalence of contraindications in American women aged 20-51 years (Contraception 2007;75:355-60).

Dr. Burke serves on the steering committee of the Oral Contraceptives Over the Counter (OCs OTC) Working Group, a coalition formed in 2004 aimed at making oral contraceptives available to U.S. women without need for prescriptions.

Since its founding, the group has worked to "consolidate what we know about this issue, build consensus, disseminate information, and engage with drug companies," said Dr. Daniel Grossman, an ob.gyn. who is vice president for research of Ibis Reproductive Health, a nonprofit organization that researches reproductive health, and coordinator of the OCs OTC Working Group.

"Although this result from the St. Louis program is very interesting, it is much more likely that the Food and Drug Administration will approve a progestin-only contraceptive for OTC use," Dr. Grossman said in an interview. In part, that’s because the FDA has already approved an OTC progestin-only emergency contraceptive formulation. "We see a progestin-only OTC contraceptive as an interim step, but a more realistic step. Getting a combined hormonal contraceptive made OTC by the FDA would be a real challenge," he said. Another advantage to progestin-only pills is they have fewer contraindications than do combined hormonal pills.

Eventually, the FDA may be willing to make a combined hormonal pill available OTC under conditions of safe use, such as having sales tied to an automated kiosk that would also guide women through the contraindications and record their blood pressure. Another option for the FDA is to limit initial sale of combined hormonal pills to women with prescriptions, but allow refills on an OTC basis.

A major barrier to any oral contraceptive becoming OTC is the need for a manufacturer to apply to the FDA. "No manufacturer has said it is willing to apply," Dr. Grossman said.

In addition to trying to persuade a manufacturer to cooperate, "the next step is to show the FDA that women can self-identify their contraindications," Dr. Grossman said. A study he published in 2008 showed that 7% of women incorrectly thought that they were candidates for oral contraceptive use when in fact they had a contraindication (Obstet. Gynecol. 2008;112:572-8). This rate was almost identical to the 6% rate of contraindications found in women who had received an oral contraceptive prescription in the 2007 NHANES analysis (Contraception 2007;75:355-60).The main contraindication women have trouble self-identifying is hypertension, especially when undiagnosed, he said. In the St. Louis study, hypertension caused 71% of the true contraindications.

Ob.gyn. researchers at Washington University in St. Louis enrolled roughly 10,000 area women in the Contraceptive CHOICE program and provided them with free contraception of their choice to promote reversible, long-term methods of contraception. The current study focused on 1,010 participants in the program who opted to receive a combined hormonal contraceptive. The researchers tallied the number of women with a true medical contraindication for a combined hormonal contraceptive based on health records, reported Ms. Xu, a researcher in the department of ob.gyn. at Washington University in St. Louis, and her associates. Contraindications were a documented history of breast cancer, hypertension, myocardial infarction, transient ischemic attack, cerebral vascular accident, migraines with aura, any migraine at age 35 years or older, venous thromboembolism, liver disease, or smoking at age 35 or older.

Ms. Xu and her associates had no disclosures. Dr. Burke said that she has received a training grant from Merck, which markets Nexplanon. Dr. Grossman said that he has no disclosures.

PHILADELPHIA – About 1,000 St. Louis women who sought combined hormonal contraception as part of a research study had a 2.4% prevalence of a true medical contraindication for this form of contraception.

"This low prevalence supports provision of combined hormonal contraception without a prescription," concluded Hanna Xu and her associates in a poster at the meeting.

The finding may add impetus to an 8-year old project aimed at making at least some type of oral contraception available to U.S. women on an over-the-counter (OTC) basis, commented physicians involved in this effort.

©Tina Sbrigato/iStockphoto.com

"I’m pleased to see a 2.4% rate. It’s actually a bit lower than what we’ve seen in other studies," commented Dr. Anne E. Burke, an ob.gyn. at Johns Hopkins University, Baltimore. "This kind of information is important because it gets at one of the big barriers; data like this reassure us that OTC oral contraceptives are safe," she said in an interview.

Results from other studies have generally shown a higher contraindication prevalence. For example, a 2007 report based on data collected in the National Health and Nutrition Examination Survey (NHANES) 1999-2001 found a 16% prevalence of contraindications in American women aged 20-51 years (Contraception 2007;75:355-60).

Dr. Burke serves on the steering committee of the Oral Contraceptives Over the Counter (OCs OTC) Working Group, a coalition formed in 2004 aimed at making oral contraceptives available to U.S. women without need for prescriptions.

Since its founding, the group has worked to "consolidate what we know about this issue, build consensus, disseminate information, and engage with drug companies," said Dr. Daniel Grossman, an ob.gyn. who is vice president for research of Ibis Reproductive Health, a nonprofit organization that researches reproductive health, and coordinator of the OCs OTC Working Group.

"Although this result from the St. Louis program is very interesting, it is much more likely that the Food and Drug Administration will approve a progestin-only contraceptive for OTC use," Dr. Grossman said in an interview. In part, that’s because the FDA has already approved an OTC progestin-only emergency contraceptive formulation. "We see a progestin-only OTC contraceptive as an interim step, but a more realistic step. Getting a combined hormonal contraceptive made OTC by the FDA would be a real challenge," he said. Another advantage to progestin-only pills is they have fewer contraindications than do combined hormonal pills.

Eventually, the FDA may be willing to make a combined hormonal pill available OTC under conditions of safe use, such as having sales tied to an automated kiosk that would also guide women through the contraindications and record their blood pressure. Another option for the FDA is to limit initial sale of combined hormonal pills to women with prescriptions, but allow refills on an OTC basis.

A major barrier to any oral contraceptive becoming OTC is the need for a manufacturer to apply to the FDA. "No manufacturer has said it is willing to apply," Dr. Grossman said.

In addition to trying to persuade a manufacturer to cooperate, "the next step is to show the FDA that women can self-identify their contraindications," Dr. Grossman said. A study he published in 2008 showed that 7% of women incorrectly thought that they were candidates for oral contraceptive use when in fact they had a contraindication (Obstet. Gynecol. 2008;112:572-8). This rate was almost identical to the 6% rate of contraindications found in women who had received an oral contraceptive prescription in the 2007 NHANES analysis (Contraception 2007;75:355-60).The main contraindication women have trouble self-identifying is hypertension, especially when undiagnosed, he said. In the St. Louis study, hypertension caused 71% of the true contraindications.

Ob.gyn. researchers at Washington University in St. Louis enrolled roughly 10,000 area women in the Contraceptive CHOICE program and provided them with free contraception of their choice to promote reversible, long-term methods of contraception. The current study focused on 1,010 participants in the program who opted to receive a combined hormonal contraceptive. The researchers tallied the number of women with a true medical contraindication for a combined hormonal contraceptive based on health records, reported Ms. Xu, a researcher in the department of ob.gyn. at Washington University in St. Louis, and her associates. Contraindications were a documented history of breast cancer, hypertension, myocardial infarction, transient ischemic attack, cerebral vascular accident, migraines with aura, any migraine at age 35 years or older, venous thromboembolism, liver disease, or smoking at age 35 or older.

Ms. Xu and her associates had no disclosures. Dr. Burke said that she has received a training grant from Merck, which markets Nexplanon. Dr. Grossman said that he has no disclosures.

PHILADELPHIA – About 1,000 St. Louis women who sought combined hormonal contraception as part of a research study had a 2.4% prevalence of a true medical contraindication for this form of contraception.

"This low prevalence supports provision of combined hormonal contraception without a prescription," concluded Hanna Xu and her associates in a poster at the meeting.

The finding may add impetus to an 8-year old project aimed at making at least some type of oral contraception available to U.S. women on an over-the-counter (OTC) basis, commented physicians involved in this effort.

©Tina Sbrigato/iStockphoto.com

"I’m pleased to see a 2.4% rate. It’s actually a bit lower than what we’ve seen in other studies," commented Dr. Anne E. Burke, an ob.gyn. at Johns Hopkins University, Baltimore. "This kind of information is important because it gets at one of the big barriers; data like this reassure us that OTC oral contraceptives are safe," she said in an interview.

Results from other studies have generally shown a higher contraindication prevalence. For example, a 2007 report based on data collected in the National Health and Nutrition Examination Survey (NHANES) 1999-2001 found a 16% prevalence of contraindications in American women aged 20-51 years (Contraception 2007;75:355-60).

Dr. Burke serves on the steering committee of the Oral Contraceptives Over the Counter (OCs OTC) Working Group, a coalition formed in 2004 aimed at making oral contraceptives available to U.S. women without need for prescriptions.

Since its founding, the group has worked to "consolidate what we know about this issue, build consensus, disseminate information, and engage with drug companies," said Dr. Daniel Grossman, an ob.gyn. who is vice president for research of Ibis Reproductive Health, a nonprofit organization that researches reproductive health, and coordinator of the OCs OTC Working Group.

"Although this result from the St. Louis program is very interesting, it is much more likely that the Food and Drug Administration will approve a progestin-only contraceptive for OTC use," Dr. Grossman said in an interview. In part, that’s because the FDA has already approved an OTC progestin-only emergency contraceptive formulation. "We see a progestin-only OTC contraceptive as an interim step, but a more realistic step. Getting a combined hormonal contraceptive made OTC by the FDA would be a real challenge," he said. Another advantage to progestin-only pills is they have fewer contraindications than do combined hormonal pills.

Eventually, the FDA may be willing to make a combined hormonal pill available OTC under conditions of safe use, such as having sales tied to an automated kiosk that would also guide women through the contraindications and record their blood pressure. Another option for the FDA is to limit initial sale of combined hormonal pills to women with prescriptions, but allow refills on an OTC basis.

A major barrier to any oral contraceptive becoming OTC is the need for a manufacturer to apply to the FDA. "No manufacturer has said it is willing to apply," Dr. Grossman said.

In addition to trying to persuade a manufacturer to cooperate, "the next step is to show the FDA that women can self-identify their contraindications," Dr. Grossman said. A study he published in 2008 showed that 7% of women incorrectly thought that they were candidates for oral contraceptive use when in fact they had a contraindication (Obstet. Gynecol. 2008;112:572-8). This rate was almost identical to the 6% rate of contraindications found in women who had received an oral contraceptive prescription in the 2007 NHANES analysis (Contraception 2007;75:355-60).The main contraindication women have trouble self-identifying is hypertension, especially when undiagnosed, he said. In the St. Louis study, hypertension caused 71% of the true contraindications.

Ob.gyn. researchers at Washington University in St. Louis enrolled roughly 10,000 area women in the Contraceptive CHOICE program and provided them with free contraception of their choice to promote reversible, long-term methods of contraception. The current study focused on 1,010 participants in the program who opted to receive a combined hormonal contraceptive. The researchers tallied the number of women with a true medical contraindication for a combined hormonal contraceptive based on health records, reported Ms. Xu, a researcher in the department of ob.gyn. at Washington University in St. Louis, and her associates. Contraindications were a documented history of breast cancer, hypertension, myocardial infarction, transient ischemic attack, cerebral vascular accident, migraines with aura, any migraine at age 35 years or older, venous thromboembolism, liver disease, or smoking at age 35 or older.

Ms. Xu and her associates had no disclosures. Dr. Burke said that she has received a training grant from Merck, which markets Nexplanon. Dr. Grossman said that he has no disclosures.