The US Food and Drug Administration has approved the first birth control pill to be sold without a prescription in the country.
The drug Opill (norgestrel) contains one hormone progestin, and is taken daily. It was first approved by the FDA as a prescription in 1973.
It provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative impacts.
“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the US,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.
“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy,” Cavazzoni added.
Opill was found to be 93 per cent effective in preventing pregnancy with typical use, similar to prescription oral contraceptives, but must be taken at the same time every day.
The pill comes amid advocacy groups’ fight for women’s reproductive rights in the US, and working to expand contraceptive access in the wake of the Supreme Court overturning the abortion-rights ruling Roe v. Wade in 2022.
“This is a monumental decision,” Dr Melissa Simon, a professor of clinical gynaecology at Northwestern University, was quoted as saying by NBC news.
“OTC birth control is available in over 100 countries, so we’ve been behind in availing safe, effective methods such as this oral contraceptive pill to individuals who are trying to avoid pregnancy,” she added.
The FDA also cited the side effects of Opill which include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.
However, the drug regulator said that Opill should “not be used by those who have or have ever had breast cancer”. It even cautioned people with other forms of cancer to ask a doctor before use.
Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device), the FDA said.
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