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An 82-year-old woman experienced profound hypokalaemia while being treated with mifepristone for hypercortisolism and chlortalidone for leg swelling. She was initially referred to endocrinology for bilateral adrenal adenomas and started on medical therapy, including mifepristone and later chlortalidone. After developing symptoms and presenting to the emergency department, her potassium levels were found to be critically low. Treatment involved discontinuing mifepristone, starting potassium supplementation, and stabilizing her potassium levels with spironolactone, along with receiving ketoconazole for hypercortisolism. [Extracted from the article]

A 44-year-old woman experienced a lack of efficacy after receiving mifepristone and misoprostol for a medical termination of pregnancy. She had a history of cesarean births and had previously undergone surgical termination of pregnancy and a spontaneous miscarriage. After 11 days, she presented to the hospital with abdominal pain, heavy vaginal bleeding, and nausea. An ultrasound revealed a live cesarean scar ectopic pregnancy, and she was treated with methotrexate and folinic-acid, along with an intra-gestational sac injection of potassium-chloride. Follow-up ultrasounds showed the disintegration of the ectopic pregnancy, and she underwent further procedures without complications. [Extracted from the article]

An 87-year-old woman with a medical history of rheumatoid arthritis and hypertension was admitted to the hospital with constipation and lower abdominal pain. She was diagnosed with non-small cell lung cancer and hypercortisolaemia secondary to ectopic ACTH syndrome. The woman received chemotherapy for her lung cancer and was also prescribed ketoconazole and mifepristone for the hypercortisolaemia. However, her cortisol levels did not improve, indicating a lack of efficacy. She was discharged on hospice with continued use of ketoconazole and mifepristone. [Extracted from the article]

A 58-year-old man with small cell lung cancer (SCLC) exhibited lack of efficacy and acquired drug resistance during treatment with various antineoplastics. After failing to respond to pembrolizumab and atezolizumab, he was switched to off-label treatment with mifepristone, which initially showed positive results. However, after one year, the tumor developed resistance to mifepristone. Instead of seeking medical advice, the man stopped taking mifepristone and started a new drug regimen with camrelizumab and catequentinib, which also proved ineffective. The man's condition deteriorated rapidly, and he eventually passed away. [Extracted from the article]

A 58-year-old man with small cell lung cancer (SCLC) experienced lack of efficacy and acquired drug resistance during his treatment. He initially responded well to osimertinib, but later developed SCLC and did not respond to pembrolizumab or atezolizumab. He then began off-label treatment with mifepristone, which initially showed positive results but eventually the tumor developed resistance. The man then stopped taking mifepristone without consulting his oncologist and switched to camrelizumab and catequentinib, but his condition worsened and he eventually passed away. [Extracted from the article]

A 28-year-old woman experienced idiopathic intracranial hypertension while undergoing a medical termination of pregnancy using mifepristone and misoprostol. She initially presented with vaginal bleeding and later developed symptoms such as headache, vomiting, and blurred vision. The woman was diagnosed with idiopathic intracranial hypertension caused by acute hemorrhage-related anemia. Treatment included blood transfusions, medication, and evacuation of retained products of conception. Her symptoms improved with treatment, and she had no further complications during follow-up. [Extracted from the article]

The Egyptian Pharmaceutical Vigilance Center (EPVC) has published a poster on the potential adverse outcomes of uncompleted pregnancy, such as fetal death and spontaneous abortion, after in utero insulin exposure. This conclusion was reached after assessing case reports and conducting data analysis from the WHO global database of individual case safety reports. While there is no consistent evidence to support a causal association between insulin use and uncompleted pregnancy, it is recommended to emphasize the importance of diabetes control during pregnancy and expand the national pregnancy registry for medication safety monitoring. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is:• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 35-year-old woman developed reversible cholestatic hepatitis during treatment with mifepristone and ethinylestradiol/norethisterone for Cushing syndrome (CS) and secondary hypogonadism, respectively [not all dosages and routes stated; time to reaction onset not stated]. [Extracted from the article]

A 46-year-old woman developed subacute thyroiditis while being treated with pembrolizumab for metastatic uterine epithelioid trophoblastic tumor. She later experienced lack of efficacy during treatment with etoposide, methotrexate, cisplatin, and dactinomycin for the same tumor. The woman had a history of two uncomplicated pregnancies and births before being diagnosed with metastatic uterine epithelioid trophoblastic tumor. After receiving chemotherapy and undergoing surgery, she started pembrolizumab treatment, which resulted in the resolution of liver metastases but also caused subacute thyroiditis. The woman achieved complete remission after 24 cycles of pembrolizumab and continued to undergo regular CT scans for almost two years. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is:• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 73-year-old man developed bilateral adrenal hyperplasia during treatment with mifepristone for Cushing's disease [route, dosage, duration of treatment to reaction onset and outcome not stated]. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is:• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 35- year-old woman developed exogenous Cushing's syndrome following treatment with prednisone and dexamethasone. Additionally, she developed mild nausea during treatment with mifepristone for exogenous Cushing's syndrome [routes, times to reactions onsets not stated; not all dosages stated]. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is:• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 65-year-old man developed hypogonadotropic hypogonadism during treatment mifepristone for cushing's syndrome [route, duration of treatment to reaction onset and outcoime not stated]. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is:• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 53-year-old man developed weakness, fatigue, hypokalaemia and adrenal insufficiency following treatment with mifepristone for non-ACTH dependent cortisol excess [route and dosage not stated]. [Extracted from the article]

A 75-year-old man experienced hyperaldosteronism, adrenal insufficiency, and thyroid dysfunction while being treated with mifepristone for presumed Cushing's syndrome. He was admitted to the hospital with a haemorrhagic stroke and was evaluated by the endocrine service. The man had been taking mifepristone for about a year prior to his admission, and his condition was confirmed to be a result of the medication. [Extracted from the article]

A retrospective study of 204 pregnant women found that some experienced complications while receiving ethacridine, mifepristone, or misoprostol for second-trimester pregnancy termination. The women had a history of prior cesarean section and were treated with a combination of oral mifepristone and vaginal misoprostol, or with a double-balloon catheter and oral mifepristone. However, some of the women developed puerperal morbidity, laceration of the birth canal, rupture of the uterus, or placental abruption as a result of the treatment. The duration of treatments and outcomes were not provided in the study. [Extracted from the article]

A 63-year-old woman with a history of psychiatric issues and uterine cancer experienced ineffectiveness with aripiprazole, lorazepam, and sodium valproate while being treated for suicidal feelings, delusions, and agitation. She had previously been admitted to a psychiatric hospital for depression and had undergone electroconvulsive therapy (ECT) for ineffective drug therapy. During her current presentation, she also developed deep venous thrombosis and pulmonary artery embolism, which improved with treatment. She was eventually diagnosed with catatonia and underwent ECT, leading to the resolution of her symptoms. She was discharged without any relapse of catatonia or respiratory failure. [Extracted from the article]

Health Canada is aware that two Dr. Pooja websites are selling unauthorised prescription drugs for medical abortion labelled to contain mifepristone and misoprostol, and unauthorised over-the-counter drugs for emergency contraception labelled to contain levonorgestrel. Health Canada is warning consumers not to use unauthorised heath products to terminate or prevent pregnancy as they may pose serious health risks. Mifepristone and misoprostol are prescription drugs taken in sequence for the termination of pregnancy under close medical supervision, guidance and care. [Extracted from the article]

He started receiving oral hydrocortisone 11.3 mg/m SP 2 sp /day for 12 days followed by dexamethasone plus hydrocortisone impact therapy. Physical examination showed Cushing's syndrome-like symptoms including hirsutism, et al. buffalo hump, acne, et al. full moon and flushed ruddy face, central obesity and bilateral knee valgus. [Extracted from the article]

The rate of SAEs after mifepristone-misoprostol IA was also compared with the rate in 8861 women who underwent ambulatory hospital-based procedural IA at 9 weeks' gestation or earlier. The rate of the primary composite outcome within 42 days was similar after mifepristone-misoprostol IA and after procedural IA within 9 weeks' gestation (3.4 vs 3.3 per 1000) but the rate of the broader outcome was higher (31.2 v 24.9 per 1000; RR 1.25; 95% CI 1.04, 1.51). Serious adverse events (SAEs) are more likely to be reported after mifepristone/misoprostol-induced abortion (IA) than after procedural IA during the first trimester of pregnancy, according to findings of a Canadian study published in I Annals of Internal Medicine i . [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a case report, two patients (1 woman in her 30's and 1 man) [ I exact ages not stated i ] were described, who developed menorrhagia or hypotension during treatment with mifepristone for Cushing's syndrome [ I dosages, routes, durations of treatments to reactions onsets and ADRs outcomes not stated i ]. Case 1: The woman in her 30's, who had Cushing's syndrome, started receiving mifepristone. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective cohort study conducted between December 2015 and December 2019, et al. female patient [ I exact age not stated i ] was described, who developed mild hypercholesterolaemia during treatment with mifepristone for adenomyosis. After 6 months of mifepristone treatment, mild hypercholesterolaemia was noted, which later returned to normal with a low-fat diet. The female patient, who had been diagnosed with adenomyosis, had received treatment with levonorgestrel [Mirena; I dose not stated i ] releasing intrauterine device. [Extracted from the article]

During course of hospitalisation, the women developed haemorrhage characterised by blood loss > 500mL (n=1) and unspecified infection (n=1), which were attributed to mifepristone and misoprostol. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective observational study of 79 patients conducted between 2013 and 2017, et al. women [ I ages not stated i ] were described, who developed haemorrhage or unspecified infection following treatment with mifepristone and misoprostol for termination of pregnancy for fetal anomaly [TOPFA; I time to reactions onsets and outcomes not stated; not all routes stated i ]. [Extracted from the article]

On admission, sonography with color Doppler revealed dilated tortuous vessels around the mass in lower uterine segment suggesting CSP with arteriovenous malformation (AVM). Arteriovenous malformation complicating cesarean scar pregnancy: A rare case of vaginal bleeding managed successfully by uterine artery embolization. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 27-year-old woman exhibited treatment failure during treatment with mifepristone and misoprostol for termination of caesarean scar pregnancy [CSP; I dosages and routes not stated i ]. [Extracted from the article]

Thereafter, she received transvaginal misoprostol 400 g. After 3 hours, in the absence of cervical modifications (lack of efficacy), she received oral misoprostol 400 g. After 2 hours, block expulsion of the fetus and placenta was noted. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 33-year-old woman exhibited lack of efficacy following treatment with mifepristone and misoprostol for termination of pregnancy. [Extracted from the article]

Methotrexate/mifepristone/misoprostol: Oral ulcer and lack of efficacy: 2 case reports B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a single-center, retrospective study involving 61 women treated for unruptured cornual pregnancy between September 2002 and May 2012, et al. women I [ages not stated] i were described, out of whom one woman developed oral ulcer following treatment with methotrexate and another woman exhibited lack of efficacy following treatment with mifepristone and misoprostol I [not all routes stated] i [1]. While on the third day, she received oral 400µg misoprostol tablet and vaginal misoprostol 200µg tablets were placed in posterior fornix. [Extracted from the article]

Additionally, she exhibited lack of efficacy during treatment with bevacizumab, carboplatin and paclitaxel for uterine carcinosarcoma [ I routes, dosages and duration of treatment to reaction onset not stated i ]. The pathological section of the scrapings from the external cavity revealed uterine carcinosarcoma; the carcinoma component was approximately 40%, a grade-II endometrioid adenocarcinoma with squamous metaplasia, the sarcoma component was approximately 60%, and a high-grade endometrial mesenchymal sarcoma. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 53-year-old woman developed uterine carcinosarcoma during treatment with tamoxifen for breast cancer. [Extracted from the article]

At seven weeks of gestation, she underwent uterine debridement surgery for pregnancy termination due to TA progression. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a retrospective study conducted in China between January 2012 and December 2020 involving 17 pregnant women, 4 women aged 26-33 years were described who exhibited lack of efficacy while receiving cyclophosphamide, leflunomide, benazepril, aspirin, prednisone, clopidogrel or labetalol for Takayasu arteritis (TA) during pregnancy. At six weeks of gestation, she underwent uterine debridement surgery for pregnancy termination due to TA progression. [Extracted from the article]

Further findings of elevated serum CK, myohaemoglobin (Mb) and creatine kinase isoenzyme (CKMB) indicated rhabdomyolysis (RM) secondary to EAS-associated hypokalaemia; following to which, treatment with unspecified fluid was given. Based on the presentation, it was noted that irrespective of treatment with mifepristone, cisplatin and etoposide, his condition aggravated without improvement, and he subsequently died, indicating lack of efficacy. [Extracted from the article]

Two hours later, two women received I Fufangejiao i liquid and one woman received oral I Chanfukang i particles to reduce the amount of post-abortion bleeding. However, two women developed post-abortion bleeding less than the menstrual amount; while one woman developed post-abortion bleeding >1 fold of the menstrual amount secondary to mifepristone and misoprostol use. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event * Drug overdose A 34-year-old woman developed fatal uterine rupture following treatment with misoprostol for induced labour at an overdose. The pregnant woman, in February 2020, was administered misoprostol to induce labour after the fetus died in her womb [ I route and dosage not stated i ]. [Extracted from the article]

Her medical history was significant for caesarean sections (all deliveries), and her last childbirth was 7 years prior to this presentation, following which she had undergone bilateral tubal sterilisation. Placenta accreta after postpartum tubal sterilisation and Novasure endometrial ablation. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 42-year-old woman exhibited lack of efficacy to mifepristone and misoprostol during medical termination of the missed miscarriage. [Extracted from the article]

The occurrence of acute ST-segment elevated myocardial infarction secondary to proximal LAD artery occlusion was attributed to misoprostol and mifepristone. B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A 27-year-old woman developed acute ST-segment elevated myocardial infarction secondary to proximal left anterior descending artery (LAD) occlusion following treatment with mifepristone and misoprostol for medical termination of pregnancy. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event A woman [ I exact age not stated i ] exhibited lack of efficacy during treatment with mifepristone and methotrexate for termination of ectopic pregnancy [ I not all routes stated i ]. Therefore, mifepristone and methotrexate therapies were concluded to be ineffective. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a single center retrospective study involving 30 women who underwent hysteroscopy between January 2016 and December 2019 at an institute in Japan, 6 women aged 43-75 years were described, who developed atypical endometrial hyperplasia, endometrioid carcinoma or carcinosarcoma following administration of tamoxifen for invasive breast cancer. The treatment with tamoxifen was considered to be a risk factor for the development of atypical endometrial hyperplasia, endometroid carcinoma or carcinosarcoma in these women [ I times to reactions onsets and outcomes not stated i ]. [Extracted from the article]

This woman continued with pregnancy despite being treated with mifepristone and misoprostol for medical abortion (treatment failure) (n=1). B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a prospective study of 57 women treated from 1 August 2011 to 30 November 2012, four women [ I ages not stated i ] were described, who developed disseminated intravascular coagulation (DIC) (1 patient), endometritis (1 patient), peritonitis (1 patient) and treatment failure (1 patient) following treatment with mifepristone and misoprostol for medical abortion [ I not all routes stated; dosages, durations of treatments to reactions onsets and outcomes not stated i ]. [Extracted from the article]

B Author Information b An event is serious (based on the ICH definition) when the patient outcome is: * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important event In a case series of 6 women treated for caesarean scar pregnancies at a hospital between 2017 and 2019, three women aged 23-32 years were described, who experienced increased hormone chorionic gonadotropin (hCG) levels, retention of products of conception, heavy uterine bleeding or heavy vaginal bleeding following treatment with methotrexate or mifepristone [ I not all routes and times to reactions onsets clearly stated i ]. Patient 2: A 32-year-old woman, who had four previous caesarean deliveries and one pregnancy termination (G6P4), presented to hospital with moderate hypogastric pain, moderate vaginal bleeding and amenorrhoea for 8 weeks. Notably, her hCG levels decreased to 4908 mUI/mL on day 9 of therapy; however, they increased to 16 626 mUI/mL on day 14. [Extracted from the article]

After labour induction with ethacridine and misoprostol, she experienced persistent lower abdominal pain and minor vaginal bleeding (bleeding volume: 1500mL). Patient 3 (a 28-year-old woman): The woman (gravida 4, para 2), who had scar uterus due to previous surgery, was admitted due to tenderness of the uterine scar. [Extracted from the article]