Pregnancy, Ectopic

Both synchronous and asynchronous approaches to medication abortion led to outcomes on par with in-person prescribing, a finding that addresses one of the key issues justices are scheduled to consider when weighing mifepristone's regulatory approvals next month. The effectiveness and safety of medication abortions obtained via telehealth are on par with those delivered in person, with no differences in outcomes between synchronous and asynchronous communications like secure text messaging, according to a study published Thursday in Nature Medicine. The findings were drawn from more than 6,000 telehealth medication abortions dispensed by three virtual clinics to patients in 20 states and Washington, D.C., between April 2021 and January 2022. Of note, the University of California, San Francisco (UCSF) researchers’ conclusion speaks to a key point of focus in an upcoming Supreme Court case on the regulatory approval of the abortion pill mifepristone, which was used in the study. An appeals court had preserved the product’s initial Food and Drug Administration (FDA) approval but struck down the subsequent moves in 2016 and 2021 to permit, respectively, mail-order prescriptions and remote consultation and prescription over concerns that the regulator had overlooked safety risks. “This research confirms that the FDA followed science in allowing patients to get medication abortion through telehealth and the mail,” Ushma Upadhyay, Ph.D., the study’s first author, a professor at UCSF and a public health scientist with its Advancing New Standards in Reproductive Health program, said in a release from the institution. “Our findings make it abundantly clear that the case at the Supreme Court is simply an attempt to restrict access to abortion care, even in those states where it’s legal.” Overall, Upadhyay and colleagues’ review of telehealth abortion patients’ electronic records found that 97.7% were completed without evidence of a subsequent intervention or ongoing pregnancy. In-person effectiveness rate as found on mifepristone’s FDA label is 97.4%, with the researchers also citing comparison rates of 95% to 98% from other large U.S. studies of in-person prescribing. Telehealth abortion safety, or the portion of abortions not followed by a serious adverse event, was 99.75%, with ectopic pregnancies occurring at a rate of 0.14% and follow-up emergency department visits at 1.3%. These were also similar to prior data on in-person prescribing, the researchers wrote, with mifepristone’s FDA label showing an in-person safety rate of 99.7%. The observed effectiveness and safety rates were similar when breaking the sample apart into synchronous and asynchronous care, the latter of which comprised 72.3% of the sample. The overall rates were also “consistent with, although slightly lower than” similar studies from other countries and were on par with studies of self-managed medication abortion models in the U.S. and abroad. The researchers noted that remote consultations increase the medication abortion’s reach to patients who may face travel, cost and stigma-related barriers. Additionally, the similar effectiveness and safety of asynchronous telehealth approaches like secure texting are meaningful from a health equity standpoint due to their simpler tech requirements and scheduling flexibility, they wrote. Both approaches offer a way for clinicians in states with legal abortion and “shield laws” to provide medication abortion to patients living in states where it is banned, they added. “This study demonstrates that policies that restrict telehealth abortion owing to concerns or claims about effectiveness or safety need to be revisited and revised to ensure equitable access to this essential healthcare service,” they wrote. Mifepristone is used in more than half of all abortions across the U.S., with prescriptions for it and the other primary abortion-inducing drug, misoprostol, rising following the Supreme Court’s decision to overturn Roe v. Wade in 2022. The top court is scheduled to hear arguments in the case over mifepristone’s regulatory approvals on March 26. UCSF noted in its release that Upadhyay and colleagues’ study was cited in an amicus brief submitted to the Supreme Court by more than 300 reproductive health researchers. Conversely, a study that outlined concerns over mifepristone’s safety that was cited by Judge Matthew Kacsmaryk, the district court judge whose initial ruling to pull the drug triggered the higher courts’ reviews, was retracted last week by its publisher. Federal agencies as well as the healthcare and pharmaceutical industries have pushed for the Supreme Court to support the FDA’s initial and subsequent regulatory approvals. In written briefs filed ahead of the case, they argued that the product has been demonstrated as safe and does not harm those who brought the case. Overturning the approvals, however, would have disastrous effects on the FDA’s authority and “threatens profound harms to the government, healthcare system, patients and the public,” the administration’s legal team wrote.

Medicines360 and DKT WomanCare are joining forces to increase availability and use of AVIBELA, an affordable, effective, long-acting hormonal IUD developed by Medicines360, across Africa, South and Southeast Asia, Central America, and the Caribbean.SAN FRANCISCO and PARIS, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Medicines360, a global nonprofit pharmaceutical organization specializing in women’s health, and DKT WomanCare, a global marketing and distribution organization focused on increasing the availability and use of high-quality contraceptive and reproductive health products, have entered into a partnership to expand access to AVIBELA, an affordable, quality-assured, long-acting hormonal IUD that is more than 99% effective at preventing pregnancy.1 This important collaboration will help more women learn about, access, and use this highly effective, modern form of contraception. The 52 mg levonorgestrel-releasing intrauterine system (“hormonal IUD”) has been largely inaccessible in lower- and middle-income countries (LMICs) due to factors limiting availability and affordability. An estimated 218 million women in LMICs have an unmet need for modern contraception, resulting in approximately 111 million unintended pregnancies (nearly 1 in 2) each year. 2 With this strategic partnership, more women around the world will have the ability to choose from a broader mix of safe, effective, and affordable contraceptive methods, including AVIBELA. "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360. “With their proven track record of building markets for new high-quality contraceptives, DKT WomanCare will help us provide more women across the world with the contraceptive options they want and deserve. Together, we will make meaningful improvements in access to build a brighter future for women.” Leveraging their global marketing expertise and reach, DKT WomanCare will increase awareness of AVIBELA, build markets, and ensure broader access across the public and private sectors in Africa, South and Southeast Asia, Central America, and the Caribbean. DKT WomanCare will draw on the experience of its parent company, DKT International, to leverage the organization’s extensive network of national and regional offices alongside DKT WomanCare’s established partnerships with ministries of health, global procurement agencies, social marketing organizations, and commercial distributors. Lauren Archer, DKT WomanCare’s Managing Director, celebrated the partnership. “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception. We look forward to working with Medicines360 to achieve these goals.” “This partnership is a wonderful opportunity to educate users and practitioners about the benefits of hormonal IUDs, expanding long-term contraceptive options to women everywhere with quality products like AVIBELA,” said Chris Purdy, President of DKT International. As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies. Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market. AVIBELA is a trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean. For more information about AVIBELA, please visit www.avibela.com. AVIBELA™ Important Safety Information Who is not appropriate for AVIBELAContraindications to use of AVIBELA include: pregnancy; use for post-coital contraception (emergency contraception); acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy; infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor (benign or malignant); conditions associated with increased susceptibility to pelvic infections; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine system (IUS) placement; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; a previously inserted IUS that has not been removed; a history of hypersensitivity reaction to any component of AVIBELA (reactions may include rash, urticaria, and angioedema). Clinical considerations for use of AVIBELAUse AVIBELA with caution after careful assessment in patients with coagulopathy or who are taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removal of the IUS if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of AVIBELA insertion, while the remainder were diagnosed more than six months after insertion. PID is often associated with sexually transmitted infection (STI), and AVIBELA does not protect against STIs. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Pregnancy related risks with AVIBELAIn the case of pregnancy with AVIBELA in place, advise the woman of the increased risks for pregnancy complications, including miscarriage, premature delivery, infection and sepsis. Ectopic pregnancy should be excluded, and removal of the system should be considered. Removal of AVIBELA or probing of the uterus may result in spontaneous abortion. When a woman becomes pregnant with AVIBELA in place, the relative likelihood of ectopic pregnancy is increased. Ectopic pregnancy may require surgery and may result in loss of fertility. Women with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy. Be aware of other serious complications and most common adverse reactionsSome serious complications with IUSs like AVIBELA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of AVIBELA is essential in order to minimize serious infections such as GAS. Perforation (total or partial, including penetration/embedment of AVIBELA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation is suspected, the IUS should be removed as soon as possible. Delayed detection or removal of AVIBELA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. Partial or complete expulsion of AVIBELA may occur, resulting in the loss of contraceptive protection. Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts. In a large clinical trial of 1,751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include procedural bleeding, vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne. About Medicines360Located in San Francisco, California, Medicines360 is a nonprofit global women’s health pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org. About DKT WomanCare Together, non-profits DKT WomanCare and DKT International are among the largest providers of reproductive health products, services, and technology in the world. Operating in more than 100 countries, they leverage principles of social entrepreneurialism and focus on ensuring wide access and availability of products, building up the capacity of health providers, and empowering consumers. For more information, see www.dktinternational.org and www.dktwomancare.org. Contacts:Heidi GlasserDirector of Marketing and Communications, Medicines360hglasser@medicines360.org Lauren ArcherManaging Director, DKT WomanCarelauren@dktwomancare.org References: Avibela (levonorgestrel-releasing intrauterine system) 52 mg [Summary of Product Characteristics and Prescribing Information]. Impact RH360; 2022.Sully EA et al., Adding It Up: Investing in Sexual and Reproductive Health 2019, New York: Guttmacher Institute, 2020, https://www.guttmacher.org/fact-sheet/investing-sexual-and-reproductive-health-low-and-middle-income-countries

NEW YORK, Dec. 13, 2023 /PRNewswire/ -- We at Danco are gratified that the Supreme Court has granted Danco's and the United States' requests to review the Fifth Circuit's August decision invalidating changes that FDA approved to the conditions of use for Mifeprex® in 2016 and in 2021. That decision is inconsistent with established Supreme Court principles governing standing and administrative law challenges. Danco continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA. Danco remains confident in the safety and effectiveness of Mifeprex® under the 2023 REMS that currently governs its use. Because the Supreme Court's stay will remain in place until that Court issues a decision, Mifeprex® will continue to be available under the current FDA-approved conditions, which include use in pregnancy up to 10 weeks gestation, with prescribing after in-person or telehealth examination and dispensing by certified healthcare professionals, brick-and-mortar pharmacies, or mail-order pharmacies. The FDA actions at issue were well supported by extensive safety and effectiveness data from clinical trials and decades worth of real-world experience in millions of patients. The changes in 2016 and 2021—approved by FDA after careful analysis—have expanded the availability and use of Mifeprex®, providing crucial individual and public health benefits. Mifeprex® is the most commonly used medication for termination of early pregnancy. Over 5 million women have used Mifeprex® in the United States since its approval in 2000. Mifeprex® is ~97% effective in terminating early pregnancy; approximately 3% of women will require surgical intervention for ongoing pregnancy, heavy bleeding, incomplete expulsion, or other reasons such as patient request. MIFEPREX: Important Safety Information WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following MIFEPREX use. No causal relationship between the use of MIFEPREX and misoprostol and these events has been established. Atypical Presentation of Infection. Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination. A high index of suspicion is needed to rule out serious infection and sepsis. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. MIFEPREX is only available through a restricted program called the Mifepristone REMS Program. Before prescribing MIFEPREX, inform the patient about these risks. Ensure the patient knows whom to call and what to do if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise for more than 24 hours after taking misoprostol. Contraindications Administration of MIFEPREX and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) Chronic adrenal failure (risk of acute renal insufficiency) Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency) History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported) Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) Inherited porphyrias (risk of worsening or of precipitation of attacks) Use of MIFEPREX and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device ("IUD") in place (the IUD might interfere with pregnancy termination). If the IUD is removed, MIFEPREX may be used. Warnings and Precautions Infection and Sepsis As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of MIFEPREX. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection. A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. Uterine Bleeding Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion. Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia. Mifepristone REMS Program MIFEPREX is available only through a restricted program under a REMS called the Mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the Mifepristone REMS Program include the following: Prescribers must be certified with the program by completing the Prescriber Agreement Form. Patients must sign a Patient Agreement Form. MIFEPREX must only be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers. Ectopic Pregnancy MIFEPREX is contraindicated in patients with a confirmed or suspected ectopic pregnancy because MIFEPREX is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy. Rhesus Immunization The use of MIFEPREX is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization. Adverse Reactions Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness. The frequency of adverse reactions varies between studies and may be dependent on many factors including the patient population and gestational age. This is the Important Safety Information. For more information, please see the Full Prescribing Information, including BOXED WARNING and Medication Guide, available at . SOURCE Danco Laboratories