The History of Norgestrel
Norgestrel is a synthetic progestin, a man-made version of the naturally occurring hormone progesterone [1.3.5]. It's classified as a second-generation progestin and has been used in oral contraceptives for decades [1.6.1, 1.3.7]. Norgestrel works to prevent pregnancy in several ways: it thickens cervical mucus to impede sperm movement, and it can also prevent ovulation [1.3.5].
First patented in 1961, norgestrel was introduced in Germany in 1966 as part of a combination birth control pill [1.6.1]. It received approval for prescription use in the United States in 1973 under the brand name Ovrette [1.6.1, 1.7.4]. For years, it was a common option for women seeking hormonal contraception.
Why Was Norgestrel Discontinued?
In 2005, the prescription version of norgestrel, Ovrette, was discontinued in the United States [1.5.1, 1.6.7]. It's important to note that this decision was made by the manufacturer for business and marketing reasons, not due to any safety or efficacy concerns raised by the FDA [1.5.1, 1.7.4, 1.7.6, 1.7.9]. The FDA itself has affirmed that the withdrawal was not related to the drug's safety profile [1.7.6]. This distinction is crucial because it highlights that the medication itself was not deemed dangerous or ineffective.
The Re-emergence of Norgestrel as Opill
In a significant development for reproductive health access, the FDA approved norgestrel for over-the-counter (OTC) sale in July 2023 [1.5.1, 1.5.4, 1.7.1, 1.7.2, 1.7.5]. This new non-prescription version is marketed under the brand name Opill and became available to consumers in 2024 [1.5.1, 1.5.3, 1.7.4, 1.7.5]. Opill is a progestin-only pill (POP), sometimes called a "mini-pill," because it does not contain estrogen [1.5.1, 1.5.3, 1.7.1].
This move to OTC status is intended to reduce barriers to contraception access, allowing individuals to obtain a daily oral contraceptive without a prescription from a healthcare provider [1.7.2]. This is particularly beneficial for those who face challenges in accessing healthcare, such as those without insurance or who have difficulty scheduling appointments [1.5.3].
Norgestrel vs. Levonorgestrel
It's important to understand the relationship between norgestrel and another common progestin, levonorgestrel.
- Norgestrel is a racemic mixture, meaning it contains two stereoisomers: dextro-norgestrel and levonorgestrel [1.3.3, 1.3.4].
- Levonorgestrel is the biologically active component of norgestrel [1.3.3, 1.3.4]. The dextro-norgestrel component is inactive and may contribute to unnecessary side effects [1.3.2].
Because levonorgestrel is the pure, active form, some consider it a better option with the potential for fewer side effects [1.3.2].
| Feature | Norgestrel | Levonorgestrel |
|---|---|---|
| Composition | Racemic mixture of dextro-norgestrel and levonorgestrel [1.3.3, 1.3.4] | Pure active L-enantiomer [1.3.2] |
| Activity | Levonorgestrel component is biologically active [1.3.3, 1.3.4] | Biologically active [1.3.9] |
| Side Effects | May have more side effects due to the inactive component [1.3.2] | May have fewer side effects [1.3.2] |
| Generation | Second-generation progestin [1.3.7] | Second-generation progestin [1.3.7] |
Potential Side Effects and Risks of Norgestrel
Like all medications, norgestrel can cause side effects. Common side effects often include:
- Irregular menstrual periods, including spotting or bleeding between periods [1.4.1]
- Headaches [1.4.1]
- Nausea [1.4.1]
- Dizziness [1.4.1]
- Increased appetite [1.4.2]
- Stomach pain, cramps, or bloating [1.4.2]
- Acne [1.4.2]
- Breast tenderness [1.4.1]
More serious side effects can occur, and individuals should seek medical attention if they experience symptoms like severe lower abdominal pain, new or worsening migraine headaches, or yellowing of the skin or eyes [1.4.1].
There is an increased risk of an ectopic pregnancy if a person becomes pregnant while taking norgestrel [1.4.2]. Also, individuals who have or have ever had breast cancer should not use norgestrel [1.4.3].
Conclusion
The story of norgestrel is one of market dynamics and evolving access to healthcare. The discontinuation of its prescription form was a business decision, not a reflection of its safety or effectiveness [1.5.1, 1.6.7, 1.7.4, 1.7.6]. Its revival as the over-the-counter medication Opill marks a new chapter, aiming to make daily oral contraception more accessible to millions [1.7.5]. As with any medication, it's important for individuals to be aware of the potential side effects and to use it as directed to ensure its high efficacy rate of up to 98% with perfect use [1.7.1].
For more information, you can visit the FDA's page on Opill.
