In a historic moment on Thursday, July 13, the Food and Drug Administration (FDA) approved the over-the-counter sale of the oral contraceptive Opill. This makes the medication the first birth control pill that can be bought without a prescription in the U.S.
The approval of the hormonal contraceptive marks a radical moment of change since it appears amidst legal hurricanes over the reproductive rights of women.
Opill, which is also known as the mini-pill,”consists of one ingredient, norgestrel, which contains the female hormone progestin. It is a hormonal contraceptive over-the-counter medication that is expected to be more effective than most other non-prescription methods.
Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement,
“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.”
Cavazzoni continued,
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
What is an Opill made of?
OPILL 👏 IS 👏 FDA 👏 APPROVED! 👏 pic.twitter.com/aEdYMFFaLq
— Opill® (@opill_otc) July 13, 2023
Opill is a norgestrel tablet that contains the female hormone progestin. It is an oral contraceptive for women that can be effectively used to reduce the risk of a potential pregnancy.
A single tablet has 0.075 mg of the active steroid constituent, norgestrel, which is also a completely synthetic progestogen. The inactive ingredients contained in the tablet are lactose, cellulose, magnesium stearate, polacrillin potassium, and FD&C yellow 5. The chemical designation for norgestrel is (?)-13-Ethyl-17-hydroxy-18,19-dinor-17a-pregn-4-en-20-yn-one. It is used in the formula as a racemic mixture.
Possible side effects of using Opill
Although the pill has been safely approved by the FDA as a potent OTC oral contraceptive, it may have certain possible side effects for people who might be allergic to any of the ingredients contained in it.
The following is a list of certain common Opill side effects:
- Dizziness
- Headache
- Nausea
- Abdominal pain
- Bloating
- Increase in appetite
- Cramps
- Vaginal discharge
- Nervousness
- Mood swings
- Fatigue
- Painful menstruation
- Breast tenderness or discomfort
- Backache
- Cysts in the ovaries
- Acne
- Menstrual irregularities (alteration in flow such as prolonged or missed periods of bleeding, and/or breakthrough spotting, or bleeding)
Instant medical care is recommended in case of the following serious side effects:
- Severe heart symptoms such as fast and irregular palpitations or heartbeats, pounding rhythmic palpitations, flutters in the chest, passing out, and/or shortness of breath.
- Complications in the eye and vision such as blurry or tunnel vision, pain, or swelling in the eye. Symptoms can also include a sudden loss of vision or the appearance of halos around lights to the eye.
- Acute headache, slurring of speech, or weakness in the limbs. Furthermore, the symptoms can include loss of cognition or coordination, stiffening of muscles, tremors, trouble walking, a feeling of unsteadiness, sweating profusely, or high fever.
How much does Opill Cost?
The Affordable Care Act requires health insurers to cap at least one prescription birth contraceptive as an extension of the benefits they have. However, this does not include any OTC pills. Hence, the affordability of the OTC tablets will depend on the price set by its manufacturer, Perrigo Company.
The company has stated its intentions to make the pill accessible and affordable, along with assisting those who might struggle with the price.
Where can you buy Opill?
The over-the-counter contraceptive is sold in a 28-day supply box, and it is expected to be available on the market soon enough. The FDA has stated that the timeline for the pill’s availability depends on Perrigo. However, the company assures consumers of the pill’s emergence in both online and offline stores in the first quarter of 2024.
Opill was first approved as a prescription drug by the FDA in 1973 and has been used by a large number of people since then as a birth control method. The FDA has stated that its approval of the medication in OTC form is for users of all reproductive ages, which also includes teenagers. It is expected to remove all obstructions to accessing birth control, reducing the risk of unwanted pregnancies.
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