(HealthDay News) — For women taking combined oral contraceptives (COCs), withdrawal during the pill pause is associated with adverse mental health symptoms, similar to those experienced during menses, according to a study published online Sept. 27 in JAMA Network Open.

Isabel A. Noachtar, from the University of Salzburg in Austria, and colleagues examined whether short-term hormonal withdrawal, which users of COCs undergo once a month (pill pause), is associated with altered mood and emotional recognition in a study involving women who used COC for 6 months or longer. The case-control study included a control group of women with natural menstrual cycles. The analysis included women aged 18 to 35 years (61 with androgenic COC use, 59 with antiandrogenic COC use, and 60 with a menstrual cycle not taking COCs).

The researchers found that COC users showed a 12.67%, 7.42%, and 23.61% increase in negative affect, anxiety, and mental health symptoms, respectively, during the pill pause vs the active intake phase. The effect size did not differ depending on progestin type or ethinylestradiol dose and was comparable with mood changes along the menstrual cycle among women with natural cycles.

Women with higher baseline depression scores had more pronounced mood worsening during the pill pause. There was no difference seen in emotion recognition performance for the active pill phase and pill pause.

“These results question the usefulness of pill pauses from a mental health perspective, and it should be explored whether long-term COC users benefit more from the mood-stabilizing effects of COCs in cases of continuous intake,” the authors write.

One author disclosed ties to the pharmaceutical industry.

Abstract/Full Text

HealthDay News — The first over-the-counter birth control pill is slated to hit drug stores in early 2024, but questions about cost and insurance coverage loom.

The US Food and Drug Administration approved Opill (norgestrel) for preventing pregnancy without a prescription in July, but pill maker Perrigo has yet to announce the price of the contraceptive. So far, only 6 states require coverage of some OTC birth control methods: California (effective in 2024), Maryland, New Jersey, New Mexico, New York, and Washington, according to KFF.

To get ahead of any potential access issues before Opill is rolled out, KFF researchers conducted interviews with 80 stakeholders from private insurance plans, state Medicaid programs, and chain pharmacies in the states that already require such coverage. They found that people will generally need to get Opill at the pharmacy counter, as opposed to off the shelves, for their plan to cover it. In some private health plans, people may be able to pay for Opill at the cashier and then seek reimbursement from their plan.

“The current system is designed for covering prescription, not OTC, drugs, and there is a lack of uniformity in billing practices which leads to confusion among many key players,” Michelle Long, a senior policy analyst for Women’s Health Policy at KFF, said during a recent KFF news conference on insurance coverage of OTC birth control. There is also an awareness gap. “Few plans provide information about this covered benefit to enrollees in enrollee-facing materials,” Long said.

There is also a need for greater awareness among pharmacists, said Don Downing, a clinical professor at the University of Washington School of Pharmacy in Seattle. Pharmacists need to know there is no age restriction and no parental consent needed for Opill (unless such restrictions are imposed in given states), Downing said during the news conference.

There is no nationally accepted claims processing system for pharmacists to use for OTC contraceptives, he added. Streamlining this process should include creating a universal dummy National Provider Identifier. Another option is for states to issue standing orders, which assert that a pharmacist is not prescribing but just fulfilling a preauthorized request to provide a product. With standing orders, pharmacists will not be filling out claims information and cannot be held liable, as they could be if they were prescribing the product.

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HealthDay News — The abortion pill mifepristone should remain legal in the US, but with significant restrictions on access to it, a federal appeals court ruled Wednesday. The decision, issued by the US Court of Appeals for the Fifth Circuit in New Orleans, effectively sets the stage for a showdown before the Supreme Court on the fate of the drug.

The lower court ruling from Texas that the federal appeals court weighed would have fully revoked the US Food and Drug Administration approval of the medication back in 2000. Instead, this latest decision will end availability of the drug by mail or telemedicine. The three-judge panel also said mifepristone can only be used through 7 weeks, instead of 10, and the drug will be required to be administered with a doctor present, the Associated Press reported.

“In loosening mifepristone’s safety restrictions, [the] FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” wrote Judge Jennifer Walker Elrod, a George W. Bush appointee to the Fifth Circuit.

But the American Medical Association (AMA) took issue with the new ruling. “Today’s decision by the Fifth Circuit Court of Appeals continues to signal a move in the wrong direction on access to mifepristone, potentially eliminating the ability to prescribe and dispense mifepristone via telemedicine and reinstating barriers to access that lack scientific evidence,” Jack Resneck, MD, immediate past president of the AMA, said in a statement. “While this decision preserves the original approval of Mifeprex and generic mifepristone, this action will undoubtedly negatively impact patients across the country if left in place.”

However, none of the restrictions will happen yet because the Supreme Court intervened in April to allow availability of the drug while the Texas case works its way through the courts. The Supreme Court, which will likely act in the coming months, could deny review, leaving in place the appeals court’s ruling, curbing access to the pill. Or it could agree to hear the appeal, throwing the future of the abortion pill in doubt, The New York Times reported.

The original Texas lawsuit was filed by conservative Christian group the Alliance Defending Freedom (ADF). An earlier lawsuit filed by that group led to the Supreme Court’s decision to overturn Roe v. Wade after nearly 5 decades.

Reacting to the news, the alliance issued a statement applauding the ruling. “The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” said ADF Senior Counsel Erin Hawley, who is also vice president of the ADF Center for Life and Regulatory Practice. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen.”

Health care providers have said they will switch to using only the other drug used in the typically two-drug medication abortions. That medication, misoprostol, is somewhat less effective, the AP reported.

Associated Press Article

The New York Times Article

The table below is a review of notable updates that occurred in April 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

“Fifty-one years ago today, the Supreme Court recognized a woman’s constitutional right to make deeply personal decisions with her doctor, free from the interference of politicians. Then, a year and a half ago, the [Supreme] Court made the extreme decision to overturn Roe and take away a constitutional right,” President Joe Biden said in a statement.

“As a result, tens of millions of women now live in states with extreme and dangerous abortion bans … In states across the country, women are being turned away from emergency rooms, forced to go to court to seek permission for the medical attention they need, and made to travel hundreds of miles for health care,” he added.

The new measures announced by the White House are multi-pronged: First, federal agencies will issue guidance to help make free contraceptives more available under the Affordable Care Act and to expand contraception access for federal employees. Meanwhile, the US Department of Health and Human Services (HHS) will also send letters to health insurers instructing them of their obligation to provide free birth control, the White House said in a news release.

The HHS has also created a new team that will enforce its interpretation of a law known as the Emergency Medical Treatment and Labor Act (EMTALA), which the Biden administration has said requires hospitals to provide emergency abortions nationwide, including in the 21 states where the procedure is now limited or banned.

“No American who believes in freedom should accept that women today have fewer rights to choose their health care than their mothers had 51 years ago,” HHS Secretary Xavier Becerra said in an agency news release.

“Abortion is health care. Contraception is health care. And health care decisions should be made by a patient with her doctor, not by politicians,” he added. “The Biden-Harris Administration is steadfast in the fight for reproductive freedom for all.”

As part of the administration’s new initiative, Biden will gather with senior officials for a meeting of his reproductive health task force on Monday, where he will be joined by several physicians who have practiced in states with abortion bans, the White House said.

The latest actions are part of Democrats’ continuing effort to focus on an issue that is popular with voters: Fifty-eight percent of all voters, including about 1 in 5 Republicans, trust Democrats more than Republicans on abortion, according to a November poll conducted by KFF, a health policy organization.

“Where abortion has been on the ballot, the American people have overwhelmingly voted to protect reproductive freedom,” Jennifer Klein, director of the White House’s Gender Policy Council, told reporters last week, the Washington Post reported.

She pointed to states such as Kansas and Ohio where voters last year sided with measures protecting abortion rights, the Post reported.

In addition to the measures announced Monday, Biden officials have said they are continuing to work with Congress to enact legislation that would guarantee a national right to abortion.

“As we’ve been really clear, the president, the vice president, everyone in the administration, the number one priority for all of us is working to pass a federal law that will restore the protections that were lost when Roe was overturned,” Klein said.

More information

The Center for Reproductive Rights has more on abortion access.

SOURCE: White House, news releases, Jan. 22, 2024; Washington Post

Kimberly Daniels, PhD, and Joyce C. Abma, PhD, from the National Center for Health Statistics in Hyattsville, Maryland, describe methods of contraception ever used by US women aged 15 to 49 years who had ever had sexual intercourse with a male partner, focusing on data collected from 11,695 women interviewed in the 2015 to 2019 National Survey of Family Growth.

The researchers found that almost all 10,122 women of reproductive age who had ever had sexual intercourse with a male partner used at least one contraceptive method at some time in their life (99.2%), including 87.8% who had ever used a “most or moderately effective reversible method,” including the pill; an injectable; a contraceptive patch, ring, or implant; or intrauterine device. Of the women, most had used the male condom with a partner, the pill, or withdrawal (94.5, 79.8, and 65.7%, respectively). Long-acting reversible contraception (intrauterine device or contraceptive implant) was used by about one in four women (24.9%), as was emergency contraception (23.5%). There was variation seen in the methods used by Hispanic origin and race, nativity among Hispanic women, education, religious affiliation and importance, and urban-rural residence.

“Among the 52.6 million women who had ever used the pill, 34.1% (or 17.9 million) discontinued use because of dissatisfaction with the method, most often because of side effects (64.1 percent of the women who stopped using it),” the authors write.

Abstract/Full Text

Valeria Lo Faro, PhD, from Uppsala University in Sweden, and colleagues estimated the risk for developing VTE when initiating OC use (first 2 years) and during continued use among women with a high genetic liability. The analysis included 244,420 participants in the UK Biobank.

The researchers found that overall, there was an increased risk for VTE during the first two years of OC use (hazard ratio [HR], 3.09; 95% CI, 3.00 to 3.20) but not during continued use (HR, 0.92; 95% CI, 0.80 to 1.05). When considering genetic risk, women in the highest polygenic risk score group had a more pronounced risk for VTE during the first 2 years of OC use. Similarly, high risk was seen among factor V Leiden and prothrombin variant carriers. The combination of a high polygenic risk score and being a factor V Leiden and prothrombin variant carrier conferred the highest risk for developing a VTE during the first 2 years of OC use (HR, 14.8; 95% CI, 9.28 to 23.6). During continued use, women with a high genetic liability also had increased VTE risk, but it was less pronounced.

“This is important knowledge for women’s health and may be important in contraception counselling,” Lo Faro said in a statement.

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