Drug approved FDA more than two decades ago for use in medical abortion and miscarriages is at risk of being pulled from the market following a ruling by a Trump-appointed federal judge in Texas on Friday.
However, a second federal judge in Washington state ruled. competing solution This will prevent the FDA from recalling the drug mifepristone from the market in the 12 states affected by the order, including Washington, Oregon, Arizona, Colorado, New Mexicoand Vermont.
Conflicting decisions could set the stage for a Supreme Court battle over a drug that is used in combination with misoprostol for medical abortion and treatment of miscarriages.
In Texas resolutionU.S. District Judge Matthew Kaczmarik said the FDA did not take into account the drug's “psychological effects or assessment of the drug's long-term medical effects.” His decision was delayed for seven days, giving the Biden administration time to appeal, which it has already done. On Friday evening the Ministry of Justice filed an appeal in the Texas case and issued a statement saying it “strongly disagrees” with the decision. The Ministry of Justice will also review Washington's decision.
As of April 8, mifepristone is still available commercially. United States. Depending on the final decision, this could mean that mifepristone, which many medical experts consider safe, could not be sold even in states where abortion is legal.
The medical community unanimously believes that mifepristone, which was first introduced approved in 2000safe according to current regulations. The American College of Obstetricians and Gynecologists, the American Medical Association, the Society of Maternal-Fetal Medicine and nine other medical organizations submitted an opinion to the U.S. District Court for the Northern District of Texas, Amarillo Division, saying there is “overwhelming evidence demonstrating that mifepristone, which has undergone rigorous testing and review, has been used safely in the United States for 23 years, is absolutely safe and effective.”
Following last year's coup Roe v. WadeTexas ruling that major medical groups say is not based on sciencewill create additional burdens for equal access to reproductive health care, including abortion care. A Christian legal group filed the lawsuit, arguing, among other things, that mifepristone is a dangerous drug and that the FDA has “failed American women and girls.”
The lawsuit is the latest step in a long-running effort to restrict or even ban abortion throughout the United States. After the Supreme Court decision was overturned CaviarMany states rushed to ban or severely restrict abortion.
As of April 2023 13 states have banned abortion in concept, according to the reproductive rights think tank Guttmacher Institute, and many states that have restrictions are also seeking to tighten them: Florida lawmakers, for example, recently introduced bills change the deadline for accessing abortion from 15 weeks to 6 weeks before many people know they are pregnant. Notably, many of the new laws restricting abortion exclude pregnant woman from being prosecuted for your own abortion, making self-medicated abortion a lifeline. Currently, medical abortions account for 53% abortions in the USA.
Even if the courts ultimately rule in favor of blocking access to the drug, doctors will continue to provide their patients with evidence-based abortion options in states where it is legal. legalsaid medical workers.
“When my patients and I work together to develop a treatment plan, my priority is to use scientific evidence to make recommendations that best address my patients' priorities, and for a third party to interfere with that process because of its own self-interest is ridiculous,” said Dr. Melissa Mio, a California-based OB-GYN and member of the advocacy group Physicians for Reproductive Health. “Yes, we will still have options because our goal is to take care of our patients, but it also means patients will have a narrower range of choices for no good reason.”
What are your abortion options if mifepristone is no longer available?
First, here's a quick explanation of how mifepristone works: When used in the 10th week of pregnancy, the drug stops the production of progesterone, which is necessary for the pregnancy to continue; Misoprostol is then given to expel the pregnant tissue from the uterus, causing cramping and bleeding.
A two-drug regimen is accepted standard of care for medical abortion, with less than 1% of patients experiencing any serious side effects, as stated by ACOG in court brief. There is a greater risk of complications and death with a colonoscopy, wisdom tooth extraction, or Viagra use.
Both drugs together are also used for miscarriage treatmentespecially in the case of a “frozen pregnancy,” which is a miscarriage in which the pregnancy has stopped but the tissue has not been removed from the body. Failure to remove fetal tissue in these cases can lead to infections and potentially life-threatening sepsis.
“Mifepristone is a very safe and effective drug that has been used by millions of patients for medical abortion and miscarriage treatment,” said Dr. Christine Brandy, a fellow at the American College of Obstetricians and Gynecologists.
If access to mifepristone is limited throughout the country, there are two alternatives.
One option is to use misoprostol alone. “Prior to the approval of mifepristone, a regimen using only misoprostol was used and was shown to be safe and effective,” Mio said. “Misoprostol-only regimens are used around the world in places where mifepristone is not available.” With the single-drug method, “multiple doses of misoprostol are taken to induce contractions so the uterus can carry the pregnancy,” she said.
However, “adding mifepristone reduces the amount of misoprostol and the time required to achieve complete termination of pregnancy,” Mio said. “Although misoprostol-only regimens are also safe and effective, banning mifepristone when we have strong evidence to support its safety is yet another way for politics to dictate the quality of care.”
Brandi said that while using misoprostol alone is an option, it may not be the best option. “There are other options for medical abortion, but the evidence shows that mifepristone in combination with misoprostol is the safest and most effective treatment regimen,” she said. Neither the evidence supporting the use of mifepristone nor ACOG's clinical guidelines have changed—only the law has changed.
Misoprostol can also be used alone to treat miscarriage, but as with elective abortion, studies have shown that adding it mifepristone to treat miscarriage is more effective.
