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2023-07-18| Trials & Approvals

The First Non-prescription Oral Contraceptive approved by FDA

by Oscar Wu
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FDA has recently approved the first non-prescription oral contraceptive pill, Opill (norgestrel), which can be purchased and taken without approaching the health professions. This marks a significant milestone since the approval of the first oral contraceptive, Enovid, on May 9, 1960, making it more convenient for people to achieve birth control.

Related article: Krystal Biotech’s First Topical Gene Therapy Approved by FDA

Opill Aims to Reduce the Social Impact of Unplanned Pregnancies

Unplanned pregnancies have been associated with significant social burdens, affecting public health, healthcare financing, educational systems, and social security. According to statistics from the Taiwanese Ministry of Health and Welfare, the annual induced abortion rate among unmarried women aged 20-49 is as high as 1.0%, with an average of 0.01 induced abortions per woman. 

Similarly, the FDA reports that in the United States, half of the 6.1 million pregnancies that occur each year are unintended. Unplanned pregnancies may lead to ignorance in early prenatal care, thereby increasing the risk of premature birth. Furthermore, when parents are not prepared for the responsibilities of raising a child, whether financially or in terms of creating a conducive environment for the child’s growth, the infant may face numerous challenges that would impact their health. These could give rise to plenty of social issues.

The availability of non-prescriptive birth control pills allows individuals to directly purchase them from pharmacies, convenience stores, or even online platforms, without approaching professional medical care. This significantly improves the accessibility of birth control medicine.

Opill Medication Guidance and Potential Side Effects

According to the FDA’s indication, it is crucial for women planning long-term contraception to take Opill at the same time every day consistently, as the effectiveness of the contraceptive relies on regular medication. Irregular medication could significantly reduce the contraceptive efficacy. In addition, Opill is not recommended for use in combination with other contraceptive methods such as other oral contraceptives, vaginal rings, contraceptive patches, implantable contraceptives, injectable contraceptives, or intrauterine devices (IUDs).

Studies on medication side effects have shown that taking Opill may alter vaginal bleeding patterns and potentially cause headaches, dizziness, nausea, changes in appetite, abdominal pain, cramps, or bloating. The FDA emphasizes that if menstrual patterns are severely affected or if pregnancy occurs, the use of Opill should be ceased. 

While birth control pills serve as an auxiliary method to reduce the risk of pregnancy, it is essential to prioritize proper sexual health education and safe practices. By promoting healthy attitudes and behaviors, we can provide a safer environment for individuals, families, and society as well.

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