The U.S. Food and Drug Administration did not directly answer if its newly approved over-the-counter contraceptive could be safely used by males who identify as “transgender women.”
The FDA announced Thursday that it has approved the first ever over-the-counter contraceptive pill, Opill (norgestrel).
“Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts,” the FDA said in a press release.
The Daily Signal asked the FDA if it approves or encourages the pill for biological males who identify as women or for women who identify as men.
The FDA responded with this: “Norgestrel is generally safe for most people who could get pregnant.”
Last week, the Centers for Disease Control and Prevention released new guidelines on biological males chestfeeding. The CDC claimed not only that men can chestfeed but also that they can give birth.
The FDA would not directly say if it considered men able to become pregnant.
The FDA’s approval of Opill means that clients do not need a prescription signed by a doctor or other medical provider to purchase this contraceptive, but can walk into their nearest drugstore or grocery store and buy it off the shelf, or purchase it online and have it mailed to them.
In order for a drug company to get its nonprescription product approved, “the FDA requires that the applicant demonstrate that the product can be used by consumers safely and effectively, relying only on the nonprescription drug labeling without any assistance from a health care professional.”
Perrigo, a drug company that specializes in producing over-the-counter medication, sponsored Opill through its recently acquired health care company HRA Pharma.
Dr. Karen Minerve Murry, the FDA official who sent a memorandum in favor of the pill, said the FDA should approve the drug because women no longer have as much access to abortion.
According to Murry’s reasoning, after the Supreme Court overturned Roe v. Wade, women became more concerned that states would restrict their ability to kill their unborn children through abortion.
“Prevention of pregnancy has become even more important in recent times, as increasingly, women in some parts of the U.S. have few options once an unintended pregnancy occurs,” Murry wrote.
Therefore, the FDA needs to approve contraceptives like this pill to give women more options to avoid motherhood, Murry reasoned.
However, the pill causes adverse effects in some women, including weight gain and depression.
In addition to these negative side effects, more women are noticing the connection between taking oral contraceptives and their increased chances of contracting cancer.
The National Cancer Institute, a website run by the National Institutes of Health, says on its webpage titled “Oral Contraceptives and Cancer Risk” that “overall … studies have provided consistent evidence that the risks of breast and cervical cancers are increased in women who use oral contraceptives.”
The FDA does not address in its press release whether Opill, a “progestin-only oral contraceptive pill,” has been known to cause cancer.
Most contraceptive pills that have been known to cause cancer do so because they contain estrogen, studies show.
One study performed by the National Library of Medicine in 2016 says “unlike studies of other oral contraceptives, studies indicate that progestin-only formulations do not increase the risk of breast cancer, although the literature is hampered by small sample sizes.”
In addition to not sharing, or not knowing, if Opill can cause cancer, the FDA claims that Opill is even “more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy.”
An FDA information webpage on Opill says, “based on the initial clinical trials of norgestrel tablets, the perfect-use effectiveness rate can be as high as 98%, meaning only 2 in 100 women will become pregnant in a year of use.”
However, the FDA also warns against using Opill as a morning-after pill or as an abortion drug.
“Opill is not for use as emergency contraception and does not prevent pregnancy after unprotected sex,” the FDA wrote in the press release.
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