Latest news with #misoprostol
Forbes
3 days ago
- General
- Forbes
Access To Abortion Pill Mifepristone Could Be Threatened, Again
In this photo illustration, packages of mifepristone tablets are displayed at a family planning ... More clinic. Mifepristone is part of a two-drug regimen to induce an abortion in the first trimester of pregnancy in combination with the drug misoprostol. (Photo illustration by) The abortion pill mifepristone is in the crosshairs of politics again, as plaintiffs in several high-profile court cases together with Republican lawmakers push for restrictions. More importantly perhaps, the Food and Drug Administration is reviewing the regulation and labeling of mifepristone, a drug with a well-established safety and effectiveness record. In an unusual move, Secretary of Health and Human Services, Robert F. Kennedy Jr., issued a statement last month to the Senate Health, Education, Labor and Pensions Committee directing the FDA to 'do a complete review' of its regulations on mifepristone, a medication used in conjunction with misoprostol in two-thirds of abortions in the United States– which has been used by more than eight million people since its approval more than two decades ago. The FDA approved mifepristone in 2000 for medication abortion. Mifepristone is a drug that blocks progesterone, which is needed for a pregnancy to continue. When taken in conjunction with misoprostol, mifepristone ends early pregnancies (up to ten weeks following conception). Mifepristone can be safely administered at home when prescribed by a provider, The FDA has allowed people to take the medication outside of a clinic setting since 2021. And that same year, the FDA further eased several conditions with respect to the prescribing and sale of mifepristone. Specifically, the regulatory authority allowed for prescriptions to be issued through telemedicine visits in addition to shipments of the product by mail, as MedPage Today reported. It appears that rising numbers of abortions using prescription drugs in the past four years may be linked to the changes instituted by the FDA. In addition, the use of medication to end pregnancies could have also been triggered by the Supreme Court decision to overturn Roe v. Wade in 2022, as a Journal of the American Medical Association study describes. But it appears that besides wanting to subject mifepristone to a new FDA review, Kennedy also wishes to reinstate the in-person dispensing requirement, which would mean women must go to a clinic to obtain mifepristone. The Supreme Court preserved convenient access to mifepristone last year, throwing out a lawsuit that sought to reinstate the previous requirements. The justices' argument, however, largely hinged on questioning the physician plaintiffs' right to sue the FDA to restore conditions rather than the substance of the case. But then, earlier this year, The Hill reported that a Texas federal judge, Matthew Kacsmaryk, is allowing three Republican-led states to move forward with a lawsuit to restrict access to mifepristone. It's noteworthy that in 2023, Kacsmaryk temporarily halted FDA's approval of mifepristone altogether. In brief, it's unclear what will happen to access as cases move through the court system and findings from the review which Kennedy ordered are revealed. Mifepristone has been in use in Europe for nearly three decades with a minimal number of reported adverse events. And the drug has had a similar safety record in the U.S since its approval in 2000. Between September 2000 and December 2018, only 24 of the more than 3.7 million women who had undergone medicated abortions have died, according to the FDA. Overall, the adverse events rate is less than 1% and the drug is considered safer than, say, over-the-counter non-steroidal anti-inflammatory drugs and anti-histamines. At least 100 studies from around the world have examined the effectiveness and safety of mifepristone and misoprostol. All peer-reviewed studies concluded that the pills are a safe method for terminating a pregnancy. Yet there seems to be a non-peer-reviewed study that's at the center of a request for the FDA to assess mifepristone. It's from the conservative think tank, the Ethics and Public Policy Center. This particular study makes claims about what it views as a high rate of serious adverse events following medication abortions. Yet, the evidence from the U.S. and around the globe suggests a highly safe and effective medication. The FDA's mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, the FDA is the federal authority for all pharmaceuticals distributed throughout the U.S., including mifepristone and misoprostol. And so, a series of court cases and Secretary Kennedy's request for another look at mifepristone set a potentially unsettling precedent in which the FDA's regulatory authority from past decisions is undermined. And it's not just mifepristone that's currently under renewed scrutiny. Consider, for example, that HHS is revisiting debunked theories of links between the measles, mumps and rubella vaccine and autism. The department has also spearheaded changes in COVID-19 vaccine recommendations that are not necessarily evidence-based, and inconsistent with prior and even current guidance from the Centers for Disease Control and Prevention.
Bloomberg
28-05-2025
- General
- Bloomberg
Why the Abortion Pill Mifepristone Is Under Renewed Scrutiny in the US
Since the US Supreme Court in 2022 overturned its Roe v. Wade decision establishing a nationwide right to an abortion, the fight over the intervention has focused largely on a pill that ends pregnancies: mifepristone. The court in June 2024 preserved the current level of access to medication abortion, the most common way to terminate a pregnancy in the country. Still, many states limit access to mifepristone, efforts continue to curtail it further, and leaders in the US Department of Health and Human Services have indicated that they are interested in a renewed review of the drug's safety. Mifepristone is an oral drug used to terminate a pregnancy. It works by blocking progesterone, a hormone that's necessary for a pregnancy to continue. Doctors prescribe it with misoprostol, a drug used to treat stomach ulcers that can also induce contractions. When taken together, the two pills have been found to effectively end pregnancies with no further intervention about 98% of the time. France was the first Western country to approve mifepristone to facilitate abortion, in 1988. Since then, more than 90 countries have followed. The US Food and Drug Administration approved the drug in 2000.
Malay Mail
23-05-2025
- Malay Mail
Melaka woman jailed nine months for death of unborn child involving abortion pills
KUALA LUMPUR, May 23 — A 21-year-old woman was sentenced to nine months' jail by the Melaka Magistrates' Court here today for taking abortion pills to terminate her five-month pregnancy last week. According to Kosmo!, magistrate Sharda Shienha Mohd. Suleiman handed down the sentence after the accused, Norazzeti Azima Awang Long, pleaded guilty when the charge was read out in court. According to the charge sheet, she had taken the drug misoprostol with the intent to induce an abortion with the intention of preventing a live birth. The offence occurred around 10pm on 12 May 2025 in a room at a unit in Imperio Residence Tower A, Melaka Tengah. The accused faced a maximum of 10 years' jail, or a fine, or both under Section 315 of the Penal Code if found guilty. Case facts revealed that she had initially gone to Melaka Hospital for breast engorgement, claiming she had suffered a miscarriage. However, she later admitted to taking abortion pills bought via TikTok and gave the foetus to a friend for burial. Deputy Public Prosecutor Syaza Nur Sharif urged the court to impose a custodial sentence, citing widespread social concerns. Defence lawyer Muhammad Izzuddin Ab. Malek appealed for a lenient sentence, noting that his client earned RM1,800 a month working at a café, and supported her 76-year-old father and two school-going siblings. He said she had taken the pills after repeated pressure from her boyfriend. The court ordered the sentence to begin from the date of her arrest on May 19.
