Half of pregnancies in the United States are unintended, meaning mistimed or unwanted at the time of conception. More than 72 million individuals of reproductive age live in the US, and 43 million of them are sexually active and at risk of unintended pregnancy, according to the Guttmacher Institute. Interventions that promote the use of effective contraception are crucial.
Until recently, nonprescription birth control methods such as condoms and spermicide were all hormone-free and considered to be less effective than prescription hormonal options. The FDA’s recent approval of the first nonprescription daily oral contraceptive, Opill (norgestrel), marks a significant milestone in access to reliable alternatives.
Below are details on safety and use to help answer potential patient questions.
What is Opill (Norgestrel)?
Opill is a progestin-only contraceptive, or “minipill,” that contains 28 days of active hormone per cycle. Progestin-only contraceptives work by increasing the viscosity of cervical mucus to inhibit sperm penetration and suppressing ovulation. Patients can start taking Opill on any day of the month, but they should use a barrier contraceptive (eg, condom) for the first 48 hours because it takes this long for the drug to start preventing pregnancy.
Opill is suitable for most people, including those who have a contraindication to estrogen and people who are smokers, breastfeeding, or have a history of migraines.
Patients should not use Opill if they:
have a history of breast cancer
are allergic to Opill or any of its ingredients, including FD&C yellow No. 5 (tartrazine) color additive
are currently using another hormonal contraceptive, including oral, vaginal ring, patch, implant, injection, or intra-uterine device (IUD) formulations
are pregnant or think they may be pregnant
were assigned male sex at birth
How Safe is Opill?
The FDA has determined that Opill can safely be used over the counter for pregnancy prevention. To obtain approval for nonprescription use, a drug’s manufacturer must demonstrate that consumers can use a product safely and effectively, relying only on the product labeling and without any assistance from a healthcare professional. In a clinical study, individuals were able to use Opill and/or use a barrier method during intercourse for the 2 days following a missed pill on 97% of days.
Opill’s most common side effects are irregular bleeding (eg, spotting, prolonged bleeding), headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating. Patients should notify a provider if they develop repeated vaginal bleeding after intercourse, prolonged episodes of bleeding, or amenorrhea (absence of menstrual period). They should also take a pregnancy test in the event of two missed periods or a single missed period following missed doses of Opill.
Is Opill as Effective as Prescription Contraceptives?
Norgestrel, the product’s active ingredient, has established efficacy since its original approval for prescription use in 1973. When used properly, Opill is 98% effective, which is equivalent to the efficacy of most prescription contraceptives. Proper use means taking Opill at approximately the same time (within 3 hours) every day. A clinical study showed that 95% of study participants were at least 85% adherent to daily Opill dosing or followed labeled directions after a missed dose.
Progestin-only contraceptives are generally less effective than combination oral contraceptives (COCs), which contain both an estrogen and a progestin. The progestin dose in Opill is about one-third that of COCs, resulting in less consistent suppression of ovulation. Because many women continue to ovulate regularly on progestin-only pills, this can put them at greater risk of breakthrough bleeding and ectopic pregnancy. Patients should be advised to seek medical attention if they experience sudden or severe persistent pain in the lower belly mostly on one side, a symptom of ectopic pregnancy.
Opill does not protect from sexually transmitted infections (including HIV/AIDS), and it is not an emergency contraceptive for pregnancy prevention after unprotected intercourse.
Is the OTC Version Less Expensive?
Although Opill’s OTC status will increase access, it faces challenges related to cost. Opill’s suggested retail price is $19.99 for a 1-month supply or $49.99 for a 3-month supply.
Federal policy requires that most private health insurance plans and Medicaid programs cover the full range of FDA-approved prescription contraceptives without a patient copay. However, this is not true of nonprescription contraception. Only nine states require private health plans and/or Medicaid to cover at least some OTC contraception without a prescription.
Those most likely to benefit financially from obtaining Opill OTC include individuals without insurance coverage who would otherwise incur the cost of a healthcare provider visit in addition to the full cost of prescription contraceptives.