For years experts of the real variety have warned about the dangers of oral contraceptives. An increased risk of breast and cervical cancers, fatal blood clotting disorders, strokes, heart attacks, hypothyroidism, infertility, and autoimmune diseases are just a few of the acknowledged potential side effects of birth control pills.
Research also shows the menstrual cycle influences multiple physiological processes in a female—from sleep, mood, ability to cope with stress, mental health, and energy to hormone balance and the immune system. In fact, it is a vital indicator of overall health.
Yet, the U.S. Food and Drug Administration (FDA) on July 13 approved the first daily over-the-counter birth control pill—Opill (norgestrel)—to prevent pregnancy. The FDA’s decision allows anyone to purchase the progestin-only contraceptive at drug stores, convenience stores, grocery stores, and online without a prescription.
This decision allows teenagers and young girls to purchase the pill without parental consent or a physician’s advice on potential harm.
This illustration provided by Perrigo in May 2023 depicts proposed packaging for the company’s birth control medication Opill
The approval marks a “truly momentous day for women’s health nationwide,” Perrigo, the pill’s manufacturer, said in a press release.
Yet, the FDA and Perrigo appeared to focus entirely on the “risks” of an unwanted pregnancy instead of the known risks of progestin and synthetic birth control’s effects on the menstrual cycle.
Opill, or the “mini-pill,” contains 0.075mg of norgestrel—a synthetic, human-made progestin that acts upon the body’s progesterone receptors and is most often used to prevent pregnancy or treat menopausal women.
Progestin-only birth control pills work by thickening cervical mucus, making it difficult for sperm to enter the uterus to fertilize an egg, preventing ovulation, and thinning the lining of the uterus. To prevent pregnancy, the pill must be taken at the same time each day.
According to the FDA, the most common side effects of Opill include “irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating,” and no one with a history of breast cancer should use it.
The long-term effects of the pill or potential adverse effects in young girls just starting their menstrual cycle were not addressed, but we know long-term and high-dose use of progestins can cause blood clots, heart attacks, strokes, liver problems, and even death.
We also know a standard 0.075mg dose of norgestrel will affect a 40-year-old, 150-pound woman differently than an 11-year-old, 90-pound girl.
How did Opill get approved?
Although it may look like Opill is a new form of birth control, norgestrel was first marketed by Pfizer and approved in 1973 under the brand name “Orvette.”
The drug was discontinued in 2005 for “business reasons” and acquired by HR Pharma, who submitted an application to the FDA in 2017 for a new name and sought to obtain data to get the drug approved without a prescription.
Perrigo then acquired Opill as part of a multi-billion-dollar deal.
During an FDA advisory meeting in May, advisors reviewing an application for over-the-counter use flagged concerns Opill could cause potential health problems in women and that some consumers may not be able to read the label or understand potential negative side effects.
As part of a study, women were paid to track and record their use of the pill, including whether they followed instructions to take it during the same three-hour window each day, which is essential to the drug’s ability to prevent pregnancy.
FDA advisors noticed the study results showed nearly 30% of women reported taking more pills than they were given—an indication they either did not understand the label or how to use it correctly.
The agency said cases of improbable dosing called the company’s results into question. Advisors also noted that half of the women in Perrigo’s study who reported unexplained bleeding incorrectly said Opill would be appropriate for their use.
Perrigo later presented a “reanalysis” of the data, excluding the participants who overreported so they could claim the study still reached its goal of demonstrating that most women used the pill correctly. FDA advisors unanimously voted to recommend the agency approve the drug.
Why is this important? For FDA approval of a product for use without a prescription, the agency requires the applicant to demonstrate the product can be used safely and effectively, relying only on nonprescription drug labeling without the assistance of a healthcare provider.
The FDA concluded consumer understanding of information on Opill from its drug label was “high overall” and that a “high proportion of consumers understood the label instructions, supporting their ability to properly use the drug when it is available as an over-the-counter product.”
But if 30% of women didn’t take it effectively during the initial study presented to the agency’s advisors just two months earlier and Perrigo excluded those results in its “reanalysis,” then despite what the FDA said in its press release, the company arguably failed to meet this requirement.
In data presented to the FDA, participants reported numerous adverse events, including heart failure, diabetic ketoacidosis, blood clots, pharyngitis streptococcal, acne, weight gain, and unintended pregnancies. Of course, the company—and ultimately the FDA—determined there were no relative safety signals. In addition to adverse events, study data included very few adolescents.
Although the FDA’s decision is being heralded as a “win” for both investors and women, the long-term effects this will have on female health are nothing short of concerning, and parents should be diligent in educating their children on the potential negative implications of using birth control pills.
Megan is an attorney and journalist with additional expertise in natural health. She has a flare for breaking down complex and controversial topics into easy-to-synthesize and entertaining pieces that empower others to make informed decisions.