Uterine Rupture

Strategic effort aims to bring stable, quality supply to providers and enhanced pricing predictability for critical labor and delivery drug CHARLOTTE, N.C. and DUBLIN, July 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) and Premier, Inc. (NASDAQ: PINC) announced today that Endo's Par Sterile Products business will supply Pitocin® (oxytocin injection, USP) vials through Premier's ProvideGx® and PremierProRx® programs. Pitocin® is used to induce labor in pregnant women. The product is on the World Health Organization's essential medications list and has a history of supply disruptions, which can result in potential health risks to mothers and babies, as well as costly delays in hospital labor and delivery wards. The partnership involves a multifaceted approach seeking to provide stable product supply through adequate safety stock on a long-term basis. "We're pleased to offer Pitocin® injection through the robust and highly reliable ProvideGx® and PremierProRx® supply channels," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "As a long-standing collaborator with Premier, we're proud to join the organization in helping to address drug shortages and serving as a reliable supplier of this labor and delivery product." "This initiative with Endo is yet another step forward to help eliminate drug shortages for our healthcare provider members, create increased market competition and promote more predictable, long-term prices," said Michael J. Alkire, President and CEO of Premier. "Both ProvideGx® and the PremierProRx® private label program are building a more diversified pharmaceutical market designed to create sustainable supply of a drug vital for maternal care and health in the U.S." Guided by health systems with more than 1,600 hospitals across the nation, Premier's ProvideGx® and PremierProRx® programs create long-term committed buying contracts with participating manufacturers—creating a steady demand signal and guaranteed buyer base in exchange for increasing production of generics in shortage, maintaining safety stocks or diversifying supply sources. These programs offer members access to more than 150 drugs that are or have been recently designated as shortage drugs, and have successfully helped resolve 14 drug shortages, resulting in their official delisting from the U.S. Food & Drug Administration's shortage list. With a stable supply of Pitocin®, Premier can continue efforts aimed at addressing factors that impact maternal and infant health outcomes, including the PINC AI™ Perinatal Improvement Collaborative that brings together more than 220 health systems in all 50 states using performance improvement tools and standardized data to measure outcomes and help identify the drivers of maternal mortality and morbidity. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Antepartum use of Pitocin is contraindicated in any of the following circumstances: Where there is significant cephalopelvic disproportion; In unfavorable fetal positions or presentations, such as transverse lies, which are undeliverable without conversion prior to delivery; In obstetrical emergencies where the benefit-to-risk ratio for either the fetus or the mother favors surgical intervention; In fetal distress where delivery is not imminent; Where adequate uterine activity fails to achieve satisfactory progress; Where the uterus is already hyperactive or hypertonic; In cases where vaginal delivery is contraindicated, such as invasive cervical carcinoma, active herpes genitalis, total placenta previa, vasa previa, and cord presentation or prolapse of the cord; In patients with hypersensitivity to the drug. WARNINGS Pitocin, when given for induction of labor or augmentation of uterine activity, should be administered only by the intravenous route and with adequate medical supervision in a hospital. PRECAUTIONS All patients receiving intravenous oxytocin must be under continuous observation by trained personnel who have a thorough knowledge of the drug and are qualified to identify complications. Electronic fetal monitoring provides the best means for early detection of overdosage. When properly administered, oxytocin should stimulate uterine contractions comparable to those seen in normal labor. Overstimulation of the uterus by improper administration can be hazardous to both mother and fetus. Even with proper administration and adequate supervision, hypertonic contractions can occur in patients whose uteri are hypersensitive to oxytocin. This fact must be considered by the physician in exercising his judgment regarding patient selection. Oxytocin should not be administered in the following conditions: fetal distress, hydramnios, partial placenta previa, prematurity, borderline cephalopelvic disproportion, and any condition in which there is a predisposition for uterine rupture, such as previous major surgery on the cervix or uterus including cesarean section, overdistention of the uterus, grand multiparity, or past history of uterine sepsis or of traumatic delivery. The decision can be made only by carefully weighing the potential benefits which oxytocin can provide in a given case against rare but definite potential for the drug to produce hypertonicity or tetanic spasm. Maternal deaths due to hypertensive episodes, subarachnoid hemorrhage, rupture of the uterus, and fetal deaths due to various causes have been reported associated with the use of parenteral oxytocic drugs for induction of labor or for augmentation in the first and second stages of labor. Oxytocin has been shown to have an intrinsic antidiuretic effect, acting to increase water reabsorption from the glomerular filtrate. Consideration should, therefore, be given to the possibility of water intoxication, particularly when oxytocin is administered continuously by infusion and the patient is receiving fluids by mouth. When oxytocin is used for induction or reinforcement of already existent labor, patients should be carefully selected. Pelvic adequacy must be considered and maternal and fetal conditions evaluated before use of the drug. ADVERSE REACTIONS The following adverse reactions have been reported in the mother: Anaphylactic reaction, postpartum hemorrhage, cardiac arrhythmia, fatal afibrinogenemia, nausea, vomiting, premature ventricular contractions, pelvic hematoma, subarachnoid hemorrhage, hypertensive episodes, and rupture of the uterus. The following adverse reactions have been reported in the fetus or neonate: Due to induced uterine motility: Bradycardia, premature ventricular contractions and other arrhythmias, permanent CNS or brain damage, fetal death, and neonatal seizures have been reported with the use of Pitocin. Due to use of oxytocin in the mother: Low Apgar scores at five minutes, neonatal jaundice, and neonatal retinal hemorrhage. DRUG INTERACTIONS Severe hypertension has been reported when oxytocin was given three to four hours following prophylactic administration of a vasoconstrictor in conjunction with caudal block anesthesia. Cyclopropane anesthesia may modify oxytocin's cardiovascular effects, so as to produce unexpected results such as hypotension. Maternal sinus bradycardia with abnormal atrioventricular rhythms has also been noted when oxytocin was used concomitantly with cyclopropane anesthesia. INDICATIONS AND USAGE Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for (1) induction of labor in patients with a medical indication for the initiation of labor, such as Rh problems, maternal diabetes, preeclampsia at or near term, when delivery is in the best interests of mother and fetus or when membranes are prematurely ruptured and delivery is indicated; (2) stimulation or reinforcement of labor, as in selected cases of uterine inertia; (3) as adjunctive therapy in the management of incomplete or inevitable abortion. In the first trimester, curettage is generally considered primary therapy. In second trimester abortion, oxytocin infusion will often be successful in emptying the uterus. Other means of therapy, however, may be required in such cases. Postpartum: Pitocin is indicated to produce uterine contractions during the third stage of labor and to control postpartum bleeding or hemorrhage. Please click for full Prescribing Information. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. About Premier, Inc. Premier, Inc. (NASDAQ: PINC) is a leading healthcare improvement company, uniting an alliance of more than 4,400 U.S. hospitals and health systems and approximately 250,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and consulting and other services, Premier enables better care and outcomes at a lower cost. Premier plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier's news and investor sites on ; as well as Twitter, Facebook, LinkedIn, YouTube, Instagram and Premier's blog for more information about the company. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Messrs. Sims and Alkire, any statements relating to product supply, reliability, availability or pricing, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect Endo's (the "Company's") current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by the Company, as well as the Company's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. View original content to download multimedia: SOURCE Endo International plc Company Codes: NASDAQ-NMS:PINC, OTC-BB:ENDPQ, OTC-PINK:ENDPQ

Medical researchers have reported a significant rise in cases of IFH injuries in recent years, with maternity staff implementing varied approaches and no consensus regarding the definition or training regarding management to help deliver the baby during CB. Over 34% of women in Australia have a caesarean birth, and a significant proportion of these happen in late labour when the fetal head is deep in the mother's pelvis and can be impacted which makes delivering a baby challenging and poses serious risks to both the mother and the baby. It's estimated the baby's head is wedged, known as impacted fetal head (IFH) in around 10% of all emergency caesarean births (CB). This makes it difficult for the doctor to get their hand below the baby's head to deliver it, which leads to longer delivery times. Recent statistics show that while the majority of babies born following IFH sustain minor damage, 2% of these infants die or suffer serious injuries with lifelong consequences.The NHS Resolution report in the UK states that 9% of avoidable brain injuries at birth are caused by impacted fetal head (IFH). Complications for the mother include increased blood loss, an increased risk of infection, bladder and urinary tract damage, uterine tears that require repair and may cause issues in subsequent pregnancies, or even a hysterectomy. While complications for the baby include lacerations and bruising to the head and face, skull fractures, and haemorrhages, there have also been reports of eye injuries. A Scientific Impact Paper published in BJOG: an International Journal of Obstetrics & Gynaecology by the Royal College of Obtsetricians & Gynaecologists in the UK and Professor Annette Briley at Flinders University has reported a significant rise in cases of IFH injuries in recent years, with maternity staff implementing varied approaches and no consensus regarding the definition or training regarding management to help deliver the baby during CB. Approaches to managing this obstetric emergency include having an assistant push the baby's head up during birth, delivering the baby feet first, using an inflatable balloon device (Fetal Pillow) designed to elevate the baby's head, and administering medication to relax the mother's womb. However, this scientific impact paper reviewed the available evidence, concluding there is currently no consensus on the best approach for these risky cases. Various manoeuvres and some devices have been introduced to help with the delivery of the baby in this situation, but to date there is no consensus on which is best for mothers and babies or the training required for staff managing this emergency situation. Most commonly, an assistant is asked to push up from below, although some evidence suggests reverse breech extraction may be associated with better outcomes. A UK-wide survey reported that more than half of obstetric registrars did not feel confident performing reverse breech extraction, and fewer than one in 10 are familiar with the Patwardhan technique. "The aim of this scientific impact paper was to examine all the current available evidence regarding different manoeuvres and devices currently in use to manage IFH, with the results integrated into the findings of a systematic review commissioned by the National Guideline Alliance (UK)," says research co-author and midwife at Flinders University, Dr. Annette Briley. The researchers say key steps need to be taken to improve standards: • High-quality adequately powered RCTs comparing techniques to manage and prevent IFH are required. (Those currently available have significant weaknesses.) • A universally accepted definition of IFH would facilitate future research and education. • Women and their partners need to inform research around the language and management of IFH. • The development and implementation of an evidence-based multi-professional educational package would lead to consistent management of this obstetric emergency. • More research is required around the efficacy and cost-effectiveness of the Fetal Pillow Dr Briley says the data clearly shows that there has been a significant rise in caesarean sections in late labour and associated cases of IFH-related injuries in recent years, and further education is needed to develop consistent management of this obstetric emergency. "We've reviewed the existing evidence on strategies to identify, prevent, and manage the IFH during births to provide guidance and recommendations that improve outcomes for mothers and babies when this potentially serious complication occurs. It's essential that clinicians use the best evidence to inform care for women and babies, including the optimal techniques to reduce the potentially devastating complications associated with IFH." Dr Briley is also part of a research team developing and evaluating the Tydeman tube, an innovative single-use, hollow silicone tube inserted to elevate the baby's head. Its designed to minimise applied pressure to the head and reduce any suction effect once access has been achieved. "A minimal number of Tydeman Tubes have been used clinically; further research in a clinical setting, compared with appropriately trained and executed manual disimpaction, is required to investigate its efficacy and safety before use."

Data showed similar costs at year one and year five for hormonal and non-hormonal IUD use, including when incorporating duration of use and surgical management of uterine perforations ROSWELL, Ga., March 21, 2023 /PRNewswire/ -- Sebela Women's Health Inc, a part of Sebela Pharmaceuticals, will present findings from a post-hoc comparison of payer costs for hormonal and non-hormonal intrauterine devices (IUDs) during the Academy of Managed Care Pharmacy Congress, March 21-24, 2023, in San Antonio, TX. Seven years of U.S. commercial claims data were analyzed to improve estimates of long-term, real-world costs, with specific attention to costs related to IUD complications and device removals. The study included paid claims from individuals aged 12-45 years who had an IUD inserted in 2014 and were continuously enrolled for one year prior and after the insertion of a new IUD. The cohort included 45,709 (72.1%) individuals with a hormonal IUD (13.5mg [Skyla®] or 52mg levonorgestrel (LNG)-releasing [Mirena®]) and 8,035 (12.7%) with a non-hormonal (copper-based [Paragard®]) IUD. The data—obtained from MarketScan®, a commercial claims database from Merative™—were examined using diagnosis codes for procedures and services related to IUD use. This approach allowed the researchers to evaluate factors impacting real-world IUD costs, such as imaging costs during device insertion/removal, the duration of device use, and procedures utilized in the management of complications. "While IUDs are one of the most effective forms of contraception available to women today, they may be underutilized. These data begin to appropriately reposition these long-acting reversible contraceptives as important options for patients, with limited meaningful economic impact to the healthcare ecosystem and payers," said study author Dr. Brian T. Nguyen, Program Director, Fellowship in Complex Family Planning, Associate Professor, Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California. The study showed that excluding insertion costs, the mean cumulative five-year costs were similar between the two IUD types: $1,548 for those with the hormonal (n=9,992) and $1,389 for the non-hormonal IUDs (n=1,509). Notably, half of all IUDs were removed within 4 years, which is shorter than the FDA-approved lifespan at the time of the study for the 52 mg LNG and copper IUDs. Costs due to complications incorporated any paid claims associated with known adverse events during the time of IUD use. In the study, surgical management of uterine perforations occurred slightly more frequently with the non-hormonal (3.5%) versus the hormonal (2.8%) IUD in the first year after insertion; cumulative five-year perforation rates were similar between the two IUD types (non-hormonal 4.8% vs. hormonal 4.4%). The incidence and costs of these complications warrant future investigation to inform future payer programs on the provision of adequate contraceptive coverage. Dr. Nguyen continued: "This comprehensive comparison of real-world utilization and costs associated with non-hormonal and hormonal IUDs identifies a need for continued innovation with IUDs, particularly now in the U.S. with the current dialogue." About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. SOURCE Sebela Pharmaceuticals Inc