Opill is the first over the counter (OTC) birth control medication in our country. With a quick stop at any local pharmacy or a website order and an expected charge of $19.95/month, this synthetic hormonal treatment is available without prescription or medical oversight. Opill utilizes artificial progestin in an attempt to limit pregnancy in women. Like other OTC drugs, Opill can now be sold to consumers regardless of age or gender with the stamp of approval from the Food and Drug Administration.
The FDA states, “Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.”
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Opill contains a single synthetic hormone, progestin, a synthetic (man-made) version of the hormone progesterone. The marketing states that “no prescription, no appointment, no hassle…you’re in control of your choices…”
Some have expressed doubts regarding this move including several Medical Advisory Council members of Heartbeat International.
Dr. George Delgado, Medical Director of Culture of Life Family Health Care and founder of the Abortion Pill Rescue Network said: “This is another example of ideology trumping safety, particularly the safety of girls. With no age restrictions, girls will be taking hormones that dramatically alter their reproductive cycles without guidance or supervision from parents or healthcare professionals.”
Dr. Anthony Levatino, who has practiced obstetrics and gynecology since 1980, agreed with this concern: “Like Dr. Delgado, I am not happy with making these OTC and used without proper medical supervision.” He also compared this charge with the wide accessibility of chemical abortion without medical oversight and continued, “We essentially have DIY abortion. Why not contraception as well?”
Dr. Catherine Stark, a licensed physician board certified in obstetrics and gynecology for the past 25 years and Medical Director at Crossroads Care Center, brought clarity to the connection with abortion and the approval of this drug:
“The information on the Opill manufacturers website has several links to the FDA application and studies they cite in the approval process. Among those are two newer articles in the journal Contraception which were authored by Mitchell Creinin looking at Norgestrel's mechanism of action.”
Creinin is well-known for his research in the development and widened accessibility of chemical abortion as well as his birth control research. He is also a paid consultant for the distributer of mifepristone. Previously providing abortions in his own clinic in Philadelphia, Creinin helped to develop mifepristone and promote the abortion pill in America.
Ironically, while his research advocates for the option to purchase progestins without a prescription, he is a critic of women choosing abortion pill reversal which utilizes progesterone, the natural version of the same drug. Creinin also helped to author a bulletin of the American College of Obstetricians and Gynecologists which warns physicians not to prescribe progestins after mifepristone or risk accidentally reversing the effects of the abortion drug. The ACOG bulletin states, “concern has been raised that the immediate use of hormonal contraception that contains progestins could theoretically interfere with medication abortion efficacy.”
As the FDA continues to remove safety guidelines once in place to protect American women with both birth control and abortion, many wonder if the abortion pill is next in line for OTC availability. Currently, abortion is available in the U.S. through abortion facilities, telehealth, abortion organizations, a number of international websites and through a number of commercial pharmacies.
Tweet This: As the FDA removes safety guidelines for both birth control and abortion, many wonder if the abortion pill is next for OTC availability.
While unintended pregnancies occur with all methods of birth control, it is more common with progestin-only medications. There is a concern from medical professionals who value preborn life for the greater number of children who will be conceived but will be unable to thrive. The hormonal disruption makes the lining of the uterus inhospitable to the growing baby and a loss is possible each month of use.
ACOG states that progestin birth control does not consistently stop ovulation and estimates at least 4 in 10 women who use progestin-only pills will continue to ovulate every month. However, this efficacy estimate might be optimistic because it demands perfect timing of the daily intake of Opill. In the approval announcement, the FDA gives warning that “adherence to daily use at the same time of day is important for the effectiveness of Opill.”
The American Association of Prolife Obstetricians and Gynecologists (AAPLOG) states that the “mechanism of action of contraceptive drugs and devices forms an essential part of informed consent prior to the start of the medication.” Because women commonly will continue to ovulate while taking progestin-only drugs, AAPLOG states: “There is much more reason for concern about embryo formation and loss with progestin-only contraceptives than with combined hormonal contraceptives because of the much greater incidence of sonographically documented follicular rupture in users of progestin-only contraceptives.”
While science firmly backs that life begins at conception, ACOG has consistently worked to redefine conception to be “the completion of implantation.” This effectively nullifies the atrocity of the abortifacient action which occurs commonly with progestin birth control.
Stark shared concerns for the lives lost with progestin birth control: “Bottom line is that progesterone only pills rarely (perhaps almost never) prevent ovulation, therefore if a fertilized egg makes it to the uterus, the endometrium is altered such that there is a failure of implantation.”
The most common side effect of this drug is unpredictable bleeding – from heavy, prolonged bleeding, to intermittent, unexpected bleeding. AAPLOG and the FDA both state this is common. Because of this side effect, many discontinue use for this reason.
Other common symptoms while taking progestin include headaches, abdominal pain, nausea, vomiting, depression, rashes, breast tenderness, swelling, weight gain and unexpected breast milk. The Mayo Clinic states that medical oversight is needed to manage these symptoms which of course is lacking with OTC or online purchases.
The increased risk of depression along with increased availability to this drug at a young age is especially concerning. Women who start taking the birth control as teens have a staggering 130% higher rate of depression occurrence, compared to non-users, according to a recent study. Without medical oversight, positive and negative effects of this drug will not be monitored.
Dr. Julie McDonald, a pharmacist, pharmacy owner and former Board of Directors for Christian Pharmacist Fellowship International (CPFI) and Board of Directors for the Alaska Pharmacists Association (AKPhA), expressed concern with the lack of medical oversight involved.
She shared: “One concern is the need to take the progesterone only tabs at the same time daily. With any medication, taking it daily (forget at the same time), I have found to be problematic for most responsible adult patients even with counseling and pharmacists/provider oversight; therefore, efficacy would be lower given the lack of counsel/oversight with OTC use not to mention there would be less opportunity for provider-patient interactions since patients would not be going in to the provider for an Rx (less screenings, interventions, etc.).”
While removing the opportunity for medical screening and counseling regarding healthy relationships and sexual behavior as well as STI testing, OTC birth control simultaneously promotes the idea that sexuality and pregnancy should be treated as disease – easily cured with one pill a day. With a false sense of security and less reason for risk avoidance while taking a drug intended to avoid pregnancy, it is yet to be seen the consequences of its unlimited OTC availability.
Tweet This: OTC birth control promotes the idea that sexuality and pregnancy should be treated as disease.
Editor's note: Heartbeat International manages Pregnancy Help News.