Washington, Jul 13 (EFE).- The Food and Drug Administration on Thursday approved the United States’ first-ever over-the-counter birth control pill.
In a statement, the FDA said it had given the green light for the Opill (norgestrel) tablet to be used without a prescription to prevent pregnancy.
“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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“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.”
The pill will be available for purchase at retail outlets such as drug stores, convenience stores and grocery stores, as well as via the Internet.
The manufacturer will determine when Opill will go on the market and at what price, the statement said.
It added that this oral contraceptive medicine “may reduce barriers to access by allowing individuals to obtain an oral contraceptive without the need to first see a health care provider.”
According to the FDA’s figures, nearly half of the 6.1 million pregnancies each year in the United States are unintended.
These unintended pregnancies, according to the statement, have been linked to negative maternal and perinatal outcomes, including premature births and associated health problems affecting newborns.
Norgestrel’s efficacy as a contraceptive was established when it was originally approved for prescription use in 1973.
The pharmaceutical company HRA Pharma had applied for the approval of norgestrel as an over-the-counter product via what the FDA refers to as a Prescription-to-Nonprescription (RX-to-OTC) switch.
To obtain a drug’s approval for non-prescription, the FDA requires that the applicant demonstrate that consumers can rely on the labeling to safely and effectively use the product without assistance from a health-care professional.
In that regard, studies showed that consumers had an overall high level of understanding of the information contained on the Opill Drug Facts label, that US government agency said.
The FDA’s statement said the pill must be taken at the same time every day to be effective.
The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea and increased appetite, the government agency said, adding that it should not be taken by those who have or have ever had breast cancer.
According to the FDA, consumers need to be aware that use of Opill simultaneously with other medications that interact with it can result in reduced efficacy and lead to unintended pregnancy.
Like other oral contraceptives, this over-the-counter pill does not protect against HIV/AIDS and other sexually transmitted diseases, the FDA said.
It cannot be used to prevent pregnancy after unprotected sex. EFE