
‘Abortion pill' found to have ‘severe adverse effects' for 1 in 10 women, study finds
Mifepristone is a "pregnancy blocker" that is used in combination with another medication, misoprostol, to terminate pregnancies, according to Mayo Clinic.
It is also used to manage early miscarriages, as it helps prepare the body to empty the uterus.
Research by the Ethics & Public Policy Center in Washington, D.C., has revealed that the rate of serious side effects is 22 times higher than what is indicated on the FDA-approved drug label.
After going through an abortion assisted by mifepristone, nearly 11% of women — more than one in 10 — reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event," according to the study summary.
The study used insurance claims data that includes more than 865,000 medication abortions prescribed between 2017 and 2023, resulting in what is described as the largest-ever dataset on chemical abortion.
"By contrast, the current FDA-approved drug label is based on the results of 10 clinical trials with a total of 30,966 women, less than 0.5 percent of whom reportedly experienced severe adverse reactions," the study states.
"Some of these trials were conducted as long as 42 years ago."
The study authors — Jamie Bryan Hall, EPPC's director of data analysis, and Ryan T. Anderson, EPPC's president — called the results a "truly shocking and sad reality."
The study used insurance claims data for more than 865,000 medication abortions prescribed between 2017 and 2023.
"We weren't exactly surprised by these findings, as other studies of smaller datasets have found significant safety problems with chemical abortion drugs — particularly after the Obama and Biden administrations removed important FDA safety protections that were required when the chemical abortion drug was first approved," the authors said in a statement sent to Fox News Digital.
"The largest limitation, which we're working to address, is that there is no insurance code for death — and sadly, we know that women die from complications resulting from the abortion pill."
Based on the study, the researchers are calling on the FDA to reinstate the original safety protections that they required when they approved mifepristone, stating that "women deserve the truth."
Christina Francis, M.D., CEO of the American Association of Pro Life OBGYNs, who is based in Ft. Wayne, Indiana, was not involved in the research but commented on the significance of the outcome.
"The findings of this study, which analyzes nearly 900,000 drug-induced abortions, align with what I have seen in my two decades of practice as an OB-GYN, during which I have cared for many women who have been lied to about the safety of abortion drugs and suffered significant complications from them," she told Fox News Digital.
Francis concluded that nearly 71,000 women likely suffered these types of severe complications in 2023, based on numbers from the Guttmacher Institute.
"This should serve as a wake-up call for the FDA that the complication rate is over 20 times higher than what has previously stated — and is a public health crisis that should be investigated immediately," she said.
"Women deserve informed consent about the potentially life-threatening dangers of these drugs."
Professor Jessie Hill, a health law expert at Case Western Reserve University in Cleveland, Ohio, also reviewed the study findings.
She stated that mifepristone has been one of the most-studied medications ever since its approval in the U.S. 25 years ago, claiming it is also "one of the safest."
Hill pointed out that the EPPC's study is not peer-reviewed and questioned its "potential bias."
"The study uses insurance claims data, but insurance claims are an imperfect proxy for causal medical outcomes," she told Fox News Digital. "They often lack context — a claim for hemorrhage, for instance, may not even be causally linked to mifepristone itself."
Hill also objected to the comparison of modern claims data to the FDA's clinical trial data.
"Clinical trials have rigorous standards for defining and reporting adverse events. Claims data are generated for billing purposes, not scientific analysis, and often overcount or misclassify events."
"Insurance claims are an imperfect proxy for causal medical outcomes."
Hill also noted that the legal standard for FDA drug regulation is not "no risk," and that all medications have adverse event rates.
"Overstating risks without weighing benefits distorts the regulatory framework," she said.
Approximately 63% of all abortions in the U.S. in 2023 were medication abortions, according to the Guttmacher Institute. This was an increase from 53% in 2020.
Fox News Digital reached out to the FDA and to the manufacturer of mifepristone for comment.
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Associated Press
3 hours ago
- Associated Press
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The GLORA-4 study is simultaneously enrolling patients at participating centers in multiple countries, to accelerate the drug's path to potential market authorization. To date, lisaftoclax is the only Bcl-2 inhibitor being advanced in a registrational Phase III trial in higher-risk MDS globally. This study, if positive, may potentially end the longstanding treatment gap in higher-risk MDS, marking yet another major milestone in the global clinical development of lisaftoclax. Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, said, 'Globally, we still lack targeted therapies for first-line treatment of patients with higher-risk MDS, which represents a huge unmet clinical need. Currently, hypomethylating agents (HMA) and allogeneic hematopoietic stem cell transplantation (allo-HSCT) remain the primary treatment options for higher-risk MDS. In earlier studies, lisaftoclax has demonstrated promising clinical benefit and tolerability. The clearances of the GLORA-4 study by the U.S. FDA and EMA, coinciding with the approval by the China CDE, pave the way for lisaftoclax to potentially become the first Bcl-2 inhibitor approved globally for first-line treatment of higher-risk MDS and the first targeted therapy approved for this indication since the introduction of HMA, which fundamentally reshapes the treatment landscape.' The GLORA-4 trial is being conducted simultaneously in China, the U.S., and Europe. This will significantly accelerate the clinical development of lisaftoclax in MDS and accelerate the drug's path to potential market authorization. Moving forward, we will remain steadfastly committed to our mission of addressing unmet clinical needs in China and around the world, actively advancing our clinical programs for the benefit of more patients.' GLORA-4 is a multi-region, multi-center, randomized, double-blind Phase III trial designed to evaluate the efficacy and safety of lisaftoclax in combination with AZA compared to placebo plus AZA in newly diagnosed adult patients with higher-risk MDS. The study was originally approved by the China CDE in 2024. Currently, the study is enrolling patients globally, with the first patients already enrolled in China and Europe. Guillermo Garcia-Manero, MD, Chair of the Department of Leukemia, The University of Texas MD Anderson Cancer Center (MDACC), and Prof. Xiaojun Huang, MD, an academician of the Chinese Academy of Engineering, director of the Institute of Hematology at Peking University, and director of the Department of Hematology at Peking University People's Hospital, are global co-leading principal investigators of the study. MDS is a myeloid clonal disease originating from hematopoietic stem cells with strongly age-correlated characteristics. Global epidemiological data of MDS show an exponential increase in incidence with age (22/100,000 in the population aged over 65 years), with a median age of diagnosis of 70 years1. More than 75% of patients with MDS present a complex disease profile that includes at least two comorbidities2. The primary risk of MDS is clonal evolution leading to progression to acute myeloid leukemia (AML), with 40-60% of higher-risk patients (high/very high risk, as classified by IPSS-R) progressing to AML within five years3. These patients have a dismal prognosis and a median survival of less than six months4. As the standard first-line therapy for higher-risk MDS, HMAs offer inadequate responses to treatment, with an overall response rate (ORR) of just 30-40%5, a complete response (CR) rate of 10-17%, and a median duration of response of 9-12 months6, 8. 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Lisaftoclax is already approved in China for adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy, including Bruton's tyrosine kinase (BTK) inhibitors. Previously, the Company released the clinical data of lisaftoclax in combination with AZA in treatment-naïve (TN) MDS during the 2024 American Society of Hematology (ASH) Annual Meeting and the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These data showed an ORR of 75%, much higher than HMAs alone, which demonstrated the clinical benefit of the combination regimen. The combination also showed a favorable safety profile, with a low incidence of severe hematologic toxicities and neutropenia-related infections. In addition, the proportion of patients requiring dose adjustments was low and there were no treatment-related mortalities within 60 days9, 10. Professor Huang commented, 'Despite the significant advancement in the treatment of hematologic malignancies, higher-risk MDS remains a major clinical challenge because of a range of factors. First, the current standard of care treatment with HMAs only offers limited efficacy, with just about one-third of patients achieving a response to treatment. Second, no breakthrough therapies have emerged globally in the two decades since the introduction of HMAs. As a result, there is an unmet clinical need for targeted therapies for higher-risk MDS. The compelling response rate and manageable safety profile observed in earlier studies of lisaftoclax are very encouraging. We hope this global Phase III study has the potential to provide new insights that could benefit how we treat and manage higher-risk MDS.' Dr. Garcia-Manero commented, 'Higher-risk MDS is more prevalent in older populations and thus presents unique clinical challenges. 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The Company is currently conducting 4 global registrational Phase III trials: the GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL who were previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed elderly and unfit patients with AML; and the GLORA-4 study in patients with newly diagnosed higher-risk MDS. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled 'Risk factors' and 'Special note regarding forward-looking statements and industry data' in its Registration Statement on Form F-1, as amended, filed with the SEC on January 21, 2025, and the Form 20-F filed with the SEC on April 16, 2025, the sections headed 'Forward-looking Statements' and 'Risk Factors' in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited we made or make from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management. As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Contact Information Investor Relations: Hogan Wan, Head of IR and Strategy Ascentage Pharma [email protected] +86 512 85557777 Stephanie Carrington ICR Healthcare [email protected] +1 (646) 277-1282 Media Relations: Jon Yu ICR Healthcare [email protected] +1 (646) 677-1855
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