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FDA approves first over-the-counter birth control pill

The Food and Drug Administration Thursday approved Opill, the first non-prescription birth control pill. It will be available online, at drugstores, grocery stores, convenience stores. Photo courtesy of FDA
The Food and Drug Administration Thursday approved Opill, the first non-prescription birth control pill. It will be available online, at drugstores, grocery stores, convenience stores. Photo courtesy of FDA

July 13 (UPI) -- The Food and Drug Administration Thursday approved Opill, the first daily over-the-counter birth control pill.

Following Thursday's decision, the pill will be available with no prescription needed at drug stores, online and at grocery and convenience stores.

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"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," Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement. "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."

Opill's approval comes in the wake of the Supreme Court ending federal abortion rights by overturning Roe vs. Wade last June.

The high court this April upheld access to mifepristone -- the key element of a two-drug cocktail commonly used in medical abortions -- after a federal judge reversed FDA approval of the drug. The U.S. 5th Circuit Court of Appeals, however, was weighing whether mifepristone should remain on the market.

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Free The Pill is a coalition of groups pushing for non-prescription access to the birth control pill said in a statement that the FDA's decision could transform contraceptive access.

"Over-the-counter birth control pills will help bridge gaps in access and give people greater control over their reproductive health and lives, Free The Pill project director Victoria Nichols . "This is a movement win led by a coalition that recognized the potential of over-the-counter birth control pills and worked for nearly two decades to build the evidence, support, and partnerships necessary to make them a reality. "

She added that to make sure women have equitable access to OTC birth control pills there must be continued advocacy to ensure the pills are affordably priced and fully covered by insurance.

"We're thrilled by the FDA's historic decision to approve Opill as the first-ever over-the-counter birth control pill. Over-the-counter access to birth control will greatly reduce the barriers that prevent Latinas/xs from getting the care they need, including barriers due to transportation, cost, language, and documentation," Lupe Rodriguez, executive director of the National Latina Institute for Reproductive Justice, said in a separate statement.

She echoed the call for making birth control pills affordable and covered by insurance.

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Arizona Gov. Katie Hobbs earlier this month ordered over-the-counter access to contraception for those 18 and over in pharmacies statewide.

She has also ordered Arizona to decline potential extradition requests from other states wanting to prosecute those who have received an abortion. The governor has directed state agencies not to assist in any investigations relating to reproductive health care that would not be punishable under Arizona law.

According to the FDA, nearly half of the 6.1 million annual U.S. pregnancies are unintended.

The FDA said unplanned pregnancies are linked to "negative maternal and perinatal outcomes, including reduced likelihood of receiving early prenatal care and increased risk of preterm delivery, with associated adverse neonatal, developmental and child health outcomes."

The efficacy of Opill's norgestrel contraceptive was established with prescription use approval in 1973. It's not for use as an emergency birth control pill.

It must be taken daily at the same time of day to be most effective.

The FDA's approval was granted to Laboratoire HRA Pharma, a subsidiary of Perrigo Company.

Opill, the FDA said, should not be used by those who have or have ever had breast cancer. It can be associated with changes in menstrual bleeding patterns.

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The most common side effects of Opill are irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating.

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