Misoprostol

FRIDAY, Aug. 30, 2024 -- Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, according to a study published in the Aug. 31 issue of The Lancet . Johanna Rydelius, M.D., from the University of Gothenburg in Sweden, and colleagues evaluated whether administering the first misoprostol dose at home could increase day-care procedures (no more than nine hours) versus overnight care procedures, shorten inpatient stays, and improve patient satisfaction. The analysis included 457 pregnant women (aged 18 years and older) undergoing medical abortion at 85 to 153 days of pregnancy who were randomly assigned to mifepristone administered in clinic followed by home administration or hospital administration of the first dose of misoprostol. The researchers found that in the home group, 71 percent of participants completed the abortion as day-care patients versus 46 percent in the hospital group. An adverse event occurred in 22 percent of participants, including seven individuals (2 percent) who aborted after mifepristone only and two (1 percent) in the home group who aborted after the first dose of misoprostol, before hospital admission. "Home administration of misoprostol significantly increases the proportion of day-care procedures in medical abortion after 12 gestational weeks, offering a safe and effective alternative to in-clinic protocols," the authors write. Two authors disclosed ties to the biopharmaceutical industry.

The U.S. Supreme Court unanimously upheld the availability of mifepristone, rejecting a lawsuit that sought to challenge the FDA's rules for prescribing and dispensing the abortion medication. This decision marks the court’s first major ruling on abortion since conservative justices overturned Roe v. Wade two years ago. The court determined that the plaintiffs, anti-abortion doctors and their groups, lacked the legal standing to challenge the FDA’s approval and regulations of mifepristone. This ruling preserves access to the medication nationwide, including in states where abortion is still legal. Currently, 14 states have total abortion bans, and three others prohibit abortion after about six weeks of pregnancy, often before women know they are pregnant. Justice Brett Kavanaugh, who voted to overturn Roe, wrote in the court’s opinion on mifepristone that “federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA’s actions.” The mifepristone case began soon after the Supreme Court overturned Roe v. Wade, with an initial ruling by a Texas judge to revoke the drug’s approval. The 5th U.S. Circuit Court of Appeals upheld the FDA’s original approval but sought to reverse the relaxed regulations, a move paused by the Supreme Court. In 2016, to enhance accessibility, the FDA updated the drug's REMS program. These revisions extended the maximum gestational age to 70 days, removed the requirement for in-person dispensing, permitted non-doctors to prescribe and administer mifepristone, and stopped the reporting of non-fatal adverse events. After a U.S. District Court Judge in Texas issued a radical ruling in April that suspended the FDA's approval of mifepristone, SCOTUS stepped in, asserting that mifepristone must remain available under the existing rules until the appeals process was complete. In August, the 5th Circuit Court of Appeals in New Orleans decided that while mifepristone should stay legal in the U.S., there should be significant restrictions on patient access, reverting to the 2016 requirements. Just a few weeks ago, the Louisiana House approved a bill adding mifepristone and misoprostol to the state's list of controlled dangerous substances.