First OTC contraceptive now available

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Online orders began this week for the first over the over-the-counter contraceptive, Opill (norgestrel; Perrigo).

First OTC contraceptive now available | Image Credit: © I Viewfinder - © I Viewfinder - stock.adobe.com.

First OTC contraceptive now available | Image Credit: © I Viewfinder - © I Viewfinder - stock.adobe.com.

The first overthe-counter contraceptive (OTC), Opill (norgestrel; Perrigo), has begun rollout, with online sales of the contraceptive starting on Monday at Opill.com and Amazon.1

Takeaways

  1. Opill marks a significant milestone as the first over-the-counter contraceptive (OTC) to be made available, providing greater accessibility for consumers.
  2. The pricing structure for Opill offers various options, with a 1-month supply priced at $19.99, a 3-month supply at $49.99, and a 6-month supply at $89.99.
  3. FDA approval for OTC use was granted in July 2023, following approval for prescription use dating back to 1973. Studies indicate that consumers can comprehend the Drug Facts label.
  4. Opill's efficacy is contingent on consistent daily use at the same time, but it may be compromised by interacting medications.
  5. Notably, Opill is not intended for emergency contraception, and it is contraindicated in patients with breast cancer or a history thereof.

According to Perrigo, the suggested retail price for Opill is $19.99 for a 1-month supply, $49.99 for a 3-month supply, and $89.99 for a 6-month supply.1

Opill received FDA approval for OTC use in July 2023 and approval for prescription use in 1973.2 During studies to determine safety and efficacy of the contraceptive by consumers without support of a health care professional, norgestrel demonstrated significant proportion of consumers were capable of comprehending information on the Drug Facts label. Additionally, proper use of norgestrel was determined to be safe and effective, showing it can be used over the counter.

In previous reporting by Contemporary OB/GYN, Opill achieved efficacy when taken at the same time once daily. However, efficacy decreased if patients used medications that interact with the contraceptive.2 The most common side effects of Opill include dizziness, headaches, nausea, irregular bleeding, abdominal pain, cramps or bloating, and increased appetite.

According to the drug label, Opill is not an emergency contraception and should not be used in patients with breast cancer or history of breast cancer. The contraceptive also should not be used with other hormonal birth control products.2

Reference

  1. Howard J. Online orders begin for first over-the-counter birth control pill in the US. CNN. March 18, 2024. Accessed March 19, 2024. https://www.cnn.com/2024/03/18/health/otc-birth-control-opill-online-orders/index.html
  2. Krewson C. First over-the-counter oral contraceptive approved by FDA. Contemporary OB/GYN. July 13, 2023. Accessed March 19, 2024. https://www.contemporaryobgyn.net/view/first-over-the-counter-oral-contraceptive-approved-by-fda
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