FDA approves first over-the-counter birth control pill with no need for prescription!

FDA has authorized the release of the first birth control pill
FDA has authorized the release of the first birth control pill. Credit | Shutterstock

United States: The US Food and Drug Administration deems it worthy of allowing the distribution of the 1st Oral Contraceptive Pill around the country, and people will be able to take it without a prescription.

About Opill pill

Opill, the oral contraceptive by the developer Perrigo, which substitutes progestin-only, will supply individuals with an opportunity to obtain this tablet without the engagement of a health care provider.

It is an attempt to reduce the barriers on the way to access to such drugs. The FDA suggests that almost half of the 6.1 million US pregnancies each year are caused by unintended ones.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “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,” as CBS reported.

“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,” as Cavazzoni added.

After the decision was declared by the FDA, the global vice president of women’s health, Frederique Welgryn, Perrigo called the approval “a historic moment and a revolutionary change in contraceptive access and reproductive health.”

Working of Opill

Visual Representation. Credit | Getty images

Opill, in medical terminology, can be described as a “progestin-only” intrauterine device that was cleared for prescription by physicians in the 1970s.

This contrasts with the pills, which these days are a combination of both the most recent “combined” formulations that also contain a bit of estrogen are primarily prescribed.

Nonetheless, hormone-based pills, requiring a prescription for thousands of women for the last five decades, are the most common form of contraception in the US, the Associated Press reports. More than 10 million women have purchased them since the first pills were introduced in the market in the 1960s.

Pills are safe and effective – FDA

Visual Representation. Credit | Getty images

FDA remarks that the product is ” safe and effective” when users follow the instructions to the letter. The regulations also include the daily intake of pill at that very time; pregnancy prevention by other any hormonal or birth control products and tablets, IUDs (intra-uterine devices); and avoidance of medications that may lack the effects of the pills.

FDA, in a statement, said, “Opill should not be used by those who have or have ever had breast cancer,” and, “Consumers who have any other form of cancer should ask a doctor before use,” as CBS reported.

FDA announced the most common side-effects of Opill –

  • Irregular bleeding
  • Headaches
  • Dizziness
  • Nausea
  • Increased appetite
  • Abdominal pain
  • Cramps or bloating

Accessibility of drug

According to the company’s statement, the pills are expected to go on sale at major retailers early next year. Moreover, there will be no age restriction for sale.

The availability of pills will be at drug stores, convenience stores, grocery stores, and online, as the FDA stated.

Welgryn said that Perigo’s motive is to make the drug “affordable and accessible to people who need it.”

Even though over-the-counter meds are usually cheaper than prescription drugs, they are unfortunately not insured and are therefore paid for by the patient.