New drug, Opill, offers a 98% rate of effectiveness in preventing conception
By Deborah Jeanne Sergeant
The FDA recently approved Opill (norgestrel) as an over-the-counter oral contraceptive.
Typically, oral contraceptives require a physician’s exam and prescription. Opill was first approved with a prescription in 1973. When taken as directed — one pill daily at the same time each day — Opill offers a 98% rate of effectiveness in preventing conception.
“I think it’s fantastic,” said Stacy Sun, OBG-YN and assistant professor in the department of obstetrics and gynecology at URMC. “It really puts patient autonomy first. It provides people an opportunity and ability to take control of what they want to do with their bodies. It’s as safe as Tylenol. Most people could take it if they chose to do so. Our patients are smart and savvy. They can take care of themselves.”
Sun said that unlike oral contraceptives that contain estrogen and progastrin, Opill is safe for people who smoke, or who have a history of blood clots, stroke or bleeding disorders.
The FDA’s website states that women who have or who have had breast cancer should not take Opill. Other contraindications include women who are pregnant or who think they might be pregnant, along with another birth control pill, vaginal ring, patch, implant, injection or an intra-uterine device (IUD), or as an “emergency contraceptive,” also known as a “morning-after pill.” Men should also not take Opill.
Dual-hormone contraceptives typically warn that’s it’s not recommended for women 35-plus; however, Opill has no such contraindication. Its safety has been established for women as young as 15; however, sale of Opill will not be limited by age.
Opill has the typical oral contraceptive side effects. The FDA listed irregular bleeding, breast tenderness, headaches, nausea, dizziness, abdominal pain, increased appetite, and bloating.
The FDA encourages women to discuss Opill with a healthcare provider or pharmacist if they currently take a prescription for drugs to treat seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension or take an over-the-counter supplement containing St. John’s Wort. Opill may interact with these drugs or become less effective. Opill can also affect the efficacy of emergency contraceptives.
Sun views Opill as a “bridge” for patients who want contraceptives but are between doctors or insurance plans. But she warned that PAP smears and routine care are still important.
The Centers for Disease Control and Prevention states on its website that “all women are at risk for gynecologic cancers, and risk increases with age.” It’s vital that women seek preventative exams on the schedule their care provider recommends, even if they use Opill.
Women taking Opill should take it for seven days prior to relying on it for contraception to better ensure its effectiveness. For many years, doctors have routinely prescribed oral contraceptives for controlling patient’s abnormal bleeding, period pain and other similar issues. But the FDA has not approved Opill for these uses. It’s vital that women seek a provider’s care for such symptoms and not try to self-diagnose and hope Opill will take care of it.
The active ingredient in Opill concerns the Rev. Jim Harden, CEO of CompassCare, which offers reproductive counseling and sexually transmitted infection testing and treatment services in Rochester, Buffalo and Albany and statewide via telehealth.
“Peer reviewed medical articles and the World Health Organization state that this exposure to steroidal contraception increases risks of cancer,” Harden said.
Harden writes extensively on medical ethics. His book “Ethical Theory and Pertinent Standards in Women’s Reproductive Health” was endorsed by the late Edmund D. Pellegrino, MD, former chair of the President’s Council on Bioethics; senior research scholar at the Kennedy Institute of Ethics; and professor emeritus of Medicine and Medical Ethics at Georgetown University.
Harden noted the National Institutes of Health’s (NIH) statement about progestin-only oral contraceptives as “at least comparable to the risk of combined oral contraceptives” which the NIH said, “increase the risk of breast cancer” as a “Group 1 carcinogen for breast cancer, as well as for cervical and liver cancer.”
The FDA’s website states that “each Opill tablet contains 0.075 mg. of a single active steroid ingredient, norgestrel, a totally synthetic progestogen.”