Access to birth control options is instrumental for sexually active people to avoid pregnancy. Right now, there’s a discussion about whether or not a certain OTC birth control pill is feasible to sell to consumers without a prescription. But the FDA raised some concerns about this certain contraceptive becoming an over-the-counter drug.

Why Access to an OTC Birth Control Pill Is More Important Than Ever

Since the Supreme Court overturned abortion rights under the US Constitution, many are now seeking more contraceptive solutions to prevent unplanned and unwanted pregnancies. Even Senate President (Pro Tempore) Rodric Bray commented about this. He said, “We are going to work pretty hard on trying to make available contraception so we can have fewer unwanted, unplanned pregnancies in the first place. I think that is a good place to start,”

It was only a matter of time before pharmaceutical companies would push for their contraceptives to be made readily available to those who need them — and that’s what HRA Pharma wishes: that Opill be made an OTC birth control pill that many can access. And the American College of Obstetricians and Gynecologists seems to support this, as they’ve been advocating for some birth control solutions to be made OTC.

What the FDA Has to Say About This

FDA officials said in a media statement that they’re worried about the risks that women can subject themselves to if the Opill (Norgestrel) becomes widely available. They also added that they’re concerned about the “improbable dosing” of the OTC birth control pill. The administration spokesperson noted that it’s because overweight people don’t seem to have as much success with Norgestrel — and the dosing may have to be adjusted based on a person’s weight in order to maximize its efficacy.

Dr. Teresa Michelle (FDA Director of the Office of Nonprescription Drugs) told the media last Tuesday, “I just wanted to note that this finding of improbable dosing in this study is really quite extraordinary.” She added, “In order for us to pick up on the fact that consumers were reporting doses that they didn’t take, they had to way over-report to the point where they were reporting dosing beyond the number of tablets that they received.”

The Known Risks of Consuming the OTC Birth Control Pill (Norgestrel) considered by the FDA

Being overweight (or obese) is just one reason why the FDA is voicing its uneasiness about having an OTC birth control pill being sold. Women with a history of breast cancer are also at risk of developing complications when taking Norgestrel.

However, HRA Pharma disputed this. According to the pharmaceutical company, among the 206 participants (whom they conducted a study on) said they had a history of breast cancer. They were warned about the potential side effects of Opill and only 6 participants still “incorrectly” decided to take the pills. But the FDA also responded by saying only 5% of the participants were literate.

Norgestrel is a hormonal contraceptive that’s supposed to mimic a woman’s natural sex hormone that’s responsible for the menstrual cycle. It’s also sometimes called the “mini pill.” This contraceptive works by producing cervical mucus that’s thick enough to make it difficult for the sperm to swim. As a result, it’s supposed to make it almost impossible for the sperm to reach the egg cell.

However, like most hormonal pills, it comes with side effects and risks that a person — and their physician — should know about.

Norgestrel side effects:

  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Weight gain
  • Breast tenderness
  • Bloating
  • Cramping
  • Weight gain
  • Hair loss
  • Hair growth in unusual areas
  • Blood clots

*A person who smokes tobacco, has liver, kidney, and/or cardiovascular disease/s, as well as a family history of blood clotting problems isn’t advised to take Norgestrel. Blood clots (thrombus) can dislodge, travel to the bloodstream, and end up clogging the veins or arteries (pulmonary embolism, cardiac embolism, or cerebral embolism). If this happens, it can lead to a heart attack or stroke.

Other Contraceptive Solutions

Currently, there are a few other contraceptive alternatives that people can use. Condoms, for instance, not only prevent unwanted and unplanned pregnancies, but they can also prevent a person from acquiring sexually-transmitted diseases.

Moreover, spermicides and contraceptive sponges can also prevent pregnancies. Though it’s somewhat painstaking to apply, use, and remember how to properly use, it’s still affordable — as both birth control options’ prices range from $10-$15 per kit.

However, if you’re looking for free birth control solutions, the Affordable Care Act (or Obamacare) allows you to purchase free to low-cost contraceptives — including birth control pills. But there’s a chance that not all types and brands of medications will be covered by your insurance policy. Just to be sure, Planned Parenthood advises that you check on their website or app to find out if the contraceptive you seek is covered by your insurance.

If you don’t have insurance, Medical News Today advises that you check with your local nonprofit organization, university, or health care center — clinics like Title X can provide family planning services that might cater to your need for a contraceptive method.


An OTC birth control pill is in the talks. It might help more people have access to a new contraceptive solution, but it can also cause or amplify a wide range of health problems for those who are at risk for certain diseases. Fortunately, there are other affordable and accessible birth control alternatives we can use for now.

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