FDA Approves First Birth Control Pill Available Without A Prescription

For the first time ever, an over-the-counter birth control pill has been approved by the FDA. This development is being marketed as a huge step forward for women, but there are many factors that need to be considered.

By Gina Florio3 min read
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The birth control pill has long been a popular method of contraception among American women, even though it was originally used as a form of eugenics. According to a survey conducted by the Centers for Disease Control and Prevention (CDC), approximately 13% of women in the United States use the birth control pill, equating to nearly 10 million women. Demographically, birth control pill usage is most prevalent among young adults, with the highest usage rates observed in women aged 20-29. According to the National Survey of Family Growth, nearly 25% of women in this age bracket reported using the pill as their primary method of contraception. For the first time ever, the pill may be available over the counter without a prescription.

FDA Approves First Birth Control Pill Without a Prescription

In a groundbreaking development, the Food and Drug Administration (FDA) approved a daily oral contraceptive pill, known as Opill (norgestrel), for over-the-counter sale on Thursday. The approval allows Opill, which comes in tablet form, to be sold over the counter in a variety of platforms ranging from online markets to drug stores, convenience stores, and grocery stores.

Patrizia Cavazzoni, the director of the FDA's Center for Drug Evaluation and Research, remarked, "Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States." She added that when used as directed, daily oral contraception such as Opill "is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."

Manufactured by Dublin-based Perrigo, Opill is a "progestin-only" pill. It uses a synthetic version of the hormone progesterone to prevent pregnancy, distinguishing itself from most birth control pills, which also contain synthetic estrogen.

"Today marks a truly momentous day for women's health nationwide," Perrigo President and CEO Patrick Lockwood-Taylor said. He pointed out the transformative potential of his company's product in improving women's access to contraception.

Opill will be sold in boxes, each containing a 28-day supply. However, the specific timeline for the pills hitting the market is yet to be determined by Perrigo. The company has projected that the pills will be available both in stores and online early in the first quarter of 2024. The pricing details remain undisclosed.

The FDA clarified that "other approved formulations and dosages of other oral contraceptives will remain available by prescription only." According to the FDA, the most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, and cramps or bloating.

"Opill should not be used by those who have or have ever had breast cancer," the FDA press release read. "Consumers who have any other form of cancer should ask a doctor before use. Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device)."

The decision marks a pivotal moment in the history of women's healthcare in the United States. By approving the first non-prescription daily oral contraceptive, the FDA has broadened access to contraception, which they consider to be a critical tool in preventing unintended pregnancies.

"Almost half of the 6.1 million pregnancies in the U.S. each year are unintended," the press release said. "Unintended pregnancies have been linked to negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes. Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts."

While the benefits of increased accessibility are clear, some potential challenges must be considered. One potential concern is the price of the over-the-counter pills. Without a prescription, these pills may not be covered by insurance, potentially placing a financial burden on individuals who rely on them.

Further, patient education will also be essential. The success of over-the-counter contraceptives depends largely on correct and consistent usage. Therefore, healthcare professionals must take proactive steps to ensure individuals have the necessary knowledge to use these contraceptives correctly.

The approval of over-the-counter daily oral contraceptives is being painted as a significant step forward in empowering individuals to take control of their reproductive health, but very few conventional medical experts are willing to also educate their patients on the negative side effects that come from the pill. Lauren, a family nurse practitioner who goes by @naturalnursemomma on Instagram, is one of many who has discussed the pill's potential to cause chronic health issues.

Lauren explains that while birth control is often a sensitive topic, it's essential to understand its effects. "Birth control just shuts off communication between the brain and the ovaries... and that has ripple effects throughout the body," she explains. Although many hail birth control as a liberating force for women, Lauren disagrees, citing personal experiences and clinical observations.

Lauren claims that the pill, classified as a group 1 carcinogen, can lead to chronic gut issues and nutrient depletion. She explains that synthetic hormones in the pill have been associated with increased risks of heart attacks and blood clotting since the 1960s. Further potential adverse effects include liver tumors, increased risk of Crohn's disease, likelihood of being prescribed antidepressants, and depletion of vital nutrients necessary for mood stability, pregnancy, and regular menstrual cycles.

Clinically, Lauren has noticed consistent patterns in women on the pill, such as deep-rooted fungal infections like candida. These can lead to chronic health issues including headaches, fatigue, gut issues, weight gain, low libido, anxiety, and depression. Post-pill conditions such as Polycystic Ovary Syndrome (PCOS), liver congestion, and infertility are common yet often overlooked by conventional medicine. Before we start handing out the pill to women over the counter, we need to ensure there is proper education about what the potential side effects and dangers are, or else there will be many more health issues around the country that cause more harm than good.

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