Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient

Gary, Margaret M; Harrison, Donna

doi:10.1345/aph.1g481

Cited by 35 publications

(15 citation statements)

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“…Contrary to our findings Gary et al, 9 feel that increased use of mifepristone/misoprostol for medical abortion may result in larger numbers of lethal infections from the clostridium sordellii bacterium. Medical abortion, according to their study, was associated with higher rates of prolonged bleeding, nausea, vomiting, and pain than is surgical abortion, and the rate of use of analgesic drugs is greater with medical abortion.…”

Section: Methodscontrasting

confidence: 99%

Study of Who Safe Abortion Regimen in Medical Abortions in a Tertiary Centre

lmeida¹,

Rao²

2015

jebmh

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Medical abortion is the use of drugs to induce abortion of a fetus. Due to the advances in the field of research, numerous regimens have been formulated to ensure a fast and complete expulsion of the fetus. These regimens also aim to towards reduced post abortal side effects and to decrease the need for surgical evacuation post medical abortion. The objective of this cross sectional analysis was to study the effectiveness of the WHO safe abortion regimen in a tertiary care hospital. METHODS: A total of 60 patients with pregnancies of 12 to 30 weeks of gestation and in whom a medical abortion was deemed necessary were chosen. After instituting the WHO SAFE ABORTION regimen they were analysed based on indication for pregnancy termination, onset of pain with WHO regimen and time of expulsion as well as post abortal side effects and the need for surgical evacuation due to failure of the WHO safe abortion regimen. Post abortion an ultrasound was done to confirm the success of the regimen. RESULTS: Majority of patients in our study was multiparous and Mean gestational age for pregnancy termination was 20.6 weeks. The most common indication for medical abortion was incidental diagnosis of fetal demise or fetal anomaly on ultrasonography (43.6%). The average duration for onset of pain was 3 hours and the average time needed for expulsion was 6 hours from the start of the Abortion regimen. The most common post abortal side effect was excessive bleeding. Only about 13.3 percent patients needed a surgical evacuation due to failure of the regimen. CONCLUSION: This study showed that the WHO safe abortion regimen is highly effective and a desirable method for medical termination of pregnancy, especially in early pregnancy and in patients in whom a surgical method of abortion could pose as a risk. The WHO SAFE ABORTION regimen has minimal post abortal side effects, need for surgical intervention and the time needed for expulsion is less. Hence it can be used as a day care regimen as well. Whenever in doubt of the completeness of the abortion, a check ultrasound is recommended post procedure to ensure completeness of expulsion.

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Section: Methodscontrasting

confidence: 99%

Study of Who Safe Abortion Regimen in Medical Abortions in a Tertiary Centre

lmeida¹,

Rao²

2015

jebmh

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“…Although initially developed in the context of the Cancer Therapy Evaluation Program,23 CTCAE have also been used for non-cancer treatment-related studies 38 39. Using CTCAE, we were able to take advantage of the specific definitions of the severity of each type of adverse event provided in this document, thus avoiding presumptuous assessments of the degree of severity of the adverse events encountered.…”

Section: Discussionmentioning

confidence: 99%

Safety of myocardial flash-contrast echocardiography in combination with dobutamine stress testing for the detection of ischaemia in 5250 studies

Aggeli¹,

Γιαννόπουλος

Roussakis

et al. 2008

Heart

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Objective: The purpose of the present study was to provide evidence regarding the safety of real-time flashcontrast echocardiography combined with dobutamineatropine stress echo (DASE). Background: The combination of perfusion assessment using myocardial contrast echocardiography (MCE) with DASE has shown very promising results for the diagnosis of coronary artery disease. Concerns have, however, been expressed regarding the safety of the use of echocontrast agents in echocardiography. Design: 5250 individuals (70.8% men, aged 64.6 years (SD 10.6)) were submitted to DASE, with concurrent MCE using a low mechanical index technique with the administration of high-energy impulses in order to assess replenishment time. Results: No deaths or myocardial infarctions were observed. Sustained ventricular tachycardia (VT) or fibrillation requiring resuscitation occurred in two cases (0.04%). The incidence of other arrhythmic events was: sustained VT not requiring resuscitation, 10 (0.18%); nonsustained VT, 18 (0.34%); atrial tachycardia, 4 (0.08%); atrial fibrillation, 25 (0.48%). Other observed adverse events included: intense headache, 52 (1%); intense back pain, 26 (0.5%). Vagal reactions with marked systolic blood pressure falls were observed in 45 cases (0.9%). Hypersensitivity reactions were reported in 23 cases (0.44%), although no serious cases of hypersensitivity requiring hospitalisation were recorded. The sensitivity, specificity and overall accuracy of DASE/MCE were 92%, 61% and 85%, respectively. Conclusions: This report of safety data regarding stresscontrast echocardiography in a large series of subjects suggests that this is an exceptionally safe technique, given that in 5250 studies no study-related deaths or myocardial infarctions were encountered, whereas serious adverse events requiring hospitalisation were extremely rare (one in 2625 studies).

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“…Similarly, the spontaneously aborted hydrocephalic fetus may have been caused by streptococcus B chorioamnionitis, which was subsequently confirmed on pathological examination. Although it could be speculated that mifepristone might have enhanced the risk of infection in this patient, several authors emphasised that the infectious risk after medical termination of pregnancy is far lower than after surgical termination of pregnancy . In addition, the 11‐week delay between mifepristone exposure and the diagnosis of infection does not support the causative role of mifepristone.…”

Section: Discussionmentioning

confidence: 86%

Continuation of pregnancy after first‐trimester exposure to mifepristone: an observational prospective study

Bernard

Eléfant

Carlier

et al. 2013

BJOG

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Objective To report the follow-up of continuing pregnancies after first-trimester exposure to mifepristone.Design Observational prospective study.Setting France.Sample Patients exposed to mifepristone during the first 12 weeks of pregnancy.Methods Women were included in the study when they or their doctors asked a French pharmacovigilance centre or the Paris Teratogen Information Service about the risk of mifepristone exposure in early pregnancy. Exclusion criteria were requests received after 22 weeks of gestation or subsequent elective termination of pregnancy without a pathological examination of the fetus. Data on maternal history and drug exposure were collected on first contact, and pregnancy outcomes were documented at follow-up.Main outcome measures Rate of major congenital malformations.Results A total of 105 pregnancies were included, with 46 exposed to mifepristone alone, and 59 exposed to both mifepristone and misoprostol. There were 94 live births (90.4%) and 10 (9.6%) miscarriages (including one with major malformation). Elective termination of pregnancy was performed after the subsequent diagnosis of trisomy 21 in one case. The overall rate of major congenital malformations was 4.2% (95% CI 1.2-10.4%), with two cases among 38 patients exposed to mifepristone alone, and two cases among 57 patients exposed to both mifepristone and misoprostol.Conclusions This first prospective study found that the rate of major malformations after first-trimester exposure to mifepristone is only slightly higher than the expected 2-3% rate in the general population. Such findings provide reassuring data for risk evaluation for continuation of pregnancy after mifepristone exposure.

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Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient

Abstract: Hemorrhage and infection are the leading causes of mifepristone-related morbidity and mortality. AERs relied upon by the FDA to monitor mifepristone's postmarketing safety are grossly deficient due to extremely poor quality.

Cited by 35 publications

References 5 publications

Study of Who Safe Abortion Regimen in Medical Abortions in a Tertiary Centre

Study of Who Safe Abortion Regimen in Medical Abortions in a Tertiary Centre

Safety of myocardial flash-contrast echocardiography in combination with dobutamine stress testing for the detection of ischaemia in 5250 studies

Continuation of pregnancy after first‐trimester exposure to mifepristone: an observational prospective study

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