Should OTC Birth Control Pills Be Sold Without Medical Oversight?

The FDA determined that Opill (norgestrel) can now be sold without a prescription. The FDA’s headline on its news release (July 13, 2023) was: “FDA Approves First Nonprescription Daily Oral Contraceptive.” In truth, norgestrel has been around for 50 years. It was approved in 1973 as a prescription contraceptive. What a lot of people want to know is how safe are these OTC birth control pills?

What Is Opill?

The active ingredient in these OTC birth control pills is norgestrel (nor JES trel). That means Opill is a progestin-only oral contraceptive. It contains 0.075 mg of oral norgestrel.

The FDA states that:

“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.”

I have no doubt that Opill will be more effective than condoms, spermicides, cervical caps, diaphragms or any other nonprescription contraceptive approach. But how safe is norgestrel?

Progestin-Only Low-Dose BC Pills

These kinds of oral contraceptives have also been called “minipills.” There are several other progestin-only contraceptives. They include Ovrette, Micronor, Errin and Nor-QD among others. Unlike many traditional BC Pills, there is no estrogen.

Side Effects of Norgestrel:

Acne
Breast tenderness, smaller breast size
Digestive distress, nausea, vomiting, cramping
Headaches
Irritability, depression
Skin rash, itching
Changes in menstrual flow, spotting between periods
Edema, fluid retention
Blood clots leading to pulmonary embolism or strokes
Scalp hair loss, oily scalp, facial hair growth
Vaginal infections

When the FDA States OTC Birth Control Pills are Safe, What Does That mean?

The FDA has repeatedly promised that it only approves medications that are “safe and effective.” And yet you have doubtless watched prescription drug commercials on television that list side effects such as seizures, heart attacks, kidney damage, liver failure, cancer and the ultimate adverse reaction…death!

The Merriam-Webster Dictionary defines safe as “not threatening danger: HARMLESS.”

What are the Side Effects of OTC Birth Control Pills Such As Norgestrel:

The FDA states that:

“Like any medication, norgestrel can have side effects. Common side effects may include irregular vaginal bleeding, nausea, breast tenderness, and headaches. These side effects are generally mild and often resolve on their own. However, if you experience severe or persistent side effects, it is important to seek medical advice.”

The Agency Answers this Question:

Q. Who should not use norgestrel?

Norgestrel should not be used:
• If you have or ever had breast cancer
• If you are already pregnant or think you may be pregnant
• Together with another birth control pill, vaginal ring, patch, implant, injection or an IUD (intra-uterine device)
• As an emergency contraceptive (morning after pill)
• If you are male

There are clearly side effects associated with norgestrel. In my opinion, medical oversight will be important so that any adverse reactions can be managed by a heath care professional promptly.

Should OTC Birth Control Pills Be Wide Available?

In my opinion, the answer is an unequivocal YES! There are far too many unintended pregnancies in the US.

That said, the FDA’s enthusiastic support of OTC birth control pills has changed since May, 2023. That was when Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription drugs suggested there was insufficient information from the drug developer (CNN Health, May 10, 2023).

She said:

““It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting. But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Women need access to effective contraceptives at a reasonable cost. As long as people are aware of the risks and pay very close attention to adverse reactions, OTC birth control pills should be readily available.

One More Thing:

According to the New York Times (July 13, 2023):

“And strikingly, at a time of fierce divisions over abortion, many anti-abortion groups have declined to criticize over-the-counter birth control.”

“In May, a panel of 17 independent scientific advisers to the F.D.A. — including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription vastly outweighed the risks.”

Comments?

What do you think? Should OTC birth control pills be widely available? Please share your thoughts in the comment section below.