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FDA approves first over-the-counter contraception pill

July 13, 2023 – Today’s FDA approval of the primary over-the-counter contraception pill for ladies is being welcomed by many as a protracted overdue development, but questions remain, including how much the drug will cost and the way it's going to be used.

The drug, called Opill, is on account of hit the market early next yr, however the manufacturer has not yet announced a retail price. It is identical contraception pill that has been available on prescription for 50 years, but for the primary time women will have the ability to purchase the contraceptive in a pharmacy, other outlets or online without having to see a physician first.

Will likely fuel the controversy

Contraception will not be without controversy within the United States. The FDA's approval triggered reactions each for and against the over-the-counter provision of hormonal contraceptives for ladies.

“These are exciting times, especially now that many states are restricting reproductive rights. Giving people an additional contraceptive option will be life-changing,” said Beverly Gray, MD, division chief of girls's and population health at Duke University Medical Center in Durham, NC.

“This is a huge victory for patients who need better access to contraception,” said Gray, who can also be a spokeswoman for the American College of Obstetricians and Gynecologists.

According to her, this could profit women who want hormonal contraception but live in an area where there isn't any doctor nearby, women who cannot easily take day off work to go to the doctor and get a prescription, and girls without medical health insurance.

The Catholic Medical Association, alternatively, expressed its “deep concern and disappointment” after an FDA advisory committee voted unanimously on May 11 to make the drug available over-the-counter. In an announcement after the vote, the group pointed to “extensive medical studies demonstrating the risks and side effects of hormonal contraceptives” and added that “the social impact of [full approval] would be dramatic.”

But the doctors largely disagreed.

“It's definitely a big win for reproductive autonomy. I'm glad the FDA is putting patient safety and well-being above politics,” said Catherine Cansino, MD, MPH, an ob-gyn and clinical professor within the department of obstetrics and gynecology on the University of California Davis. She said the FDA approved the over-the-counter version since the drug is secure.

Opponents reminiscent of the Catholic Medical Association point to safety concerns and say doctors should examine all women before prescribing hormonal contraceptives. Gray disagrees. “There is a lot of evidence that patients can find out for themselves whether a progestin-only pill is suitable and safe for them. Doctors do not have to be the gatekeepers of contraception,” she says.

Price unknown

It continues to be unclear whether medical health insurance corporations pays for Opill now that it is out there with out a prescription. For some medications, paying a co-payment through the medical health insurance company will be cheaper than buying it on the retail price.

“While price issues play a role, the FDA's decision will improve women's access to hormonal contraceptives,” said Dr. Andrew M. Kaunitz, professor and vice chair of the department of obstetrics and gynecology on the University of Florida College of Medicine in Jacksonville.

Ireland-based pharmaceutical company Perrigo has not yet announced how much the pill will cost. The price could affect how widely this way of contraception is used. The drug is claimed to be 93% effective in stopping pregnancy. Perrigo plans to supply the pill at low price or freed from charge to some women.

Reservations to be taken into consideration

There are some women for whom hormonal contraceptives have all the time posed greater risks. For example, women who've breast cancer or who've had breast cancer up to now mustn't use hormonal contraceptives, the FDA said in a Press release Announcement of approval. Women with other kinds of cancer should seek the advice of with their doctor first, the agency noted.

Women who smoke, take blood pressure medications or suffer from migraines must also be cautious, Cansino said. “For people with migraines, over-the-counter oral contraceptives may not be appropriate. But a simple test at a doctor's office can determine whether or not you are a real candidate.”

Irregular bleeding, headache, dizziness, nausea, increased appetite, abdominal pain, cramps or bloating are essentially the most common unwanted effects of Opill, in accordance with the FDA.

Opill is a pure progestin-only contraceptive pill. Similar pills have been available in UK. for about 2 years, often called “mini pills” because they contain only a single hormone. In contrast, prescription contraception pills within the US and elsewhere contain a couple of hormone, estrogen and progestin, to stop pregnancy.

Prescription pill packs for combined contraceptives often contain per week's supply of placebo pills with no lively ingredients. While skipping a placebo pill may make no difference in stopping pregnancy, Opill is different. Every pill within the pack comprises lively ingredients, Gray said. “So it's important to take the pill at the same time every day for it to be most effective.”

Even though this implies one less doctor visit, Kaunitz hopes women will proceed to have their other medical checkups regularly. “One of our challenges as health care providers for women will be to encourage them to continue to seek important services such as cancer screenings and vaccinations, even if they can take and continue to use hormonal contraceptives without contact with a doctor.”

Just the start?

The American Medical Association hopes that this approval is an indication of further successes.

“We welcome this step, but the AMA continues to urge the FDA and HHS to consider a range of oral contraceptives for over-the-counter use,” the association, which has greater than 250,000 physician members, said in an announcement. “It is important that patients have options when deciding which type of contraception is best for them,”

The American College of Obstetricians and Gynecologists said the FDA's decision will help many ladies. “We are pleased that more patients will now be able to choose when and where to get a safe birth control method without having to wait for a doctor's appointment or to fill a prescription,” Verda J. Hicks, MD, the group's president, and Christopher M. Zahn, MD, interim CEO, said in an announcement.

“Allowing people to purchase contraceptives at their local pharmacy or drugstore will remove some barriers,” they said.