scholarly journals Facts about Magnesium Sulfate: Time to Revise the Safety Concern in Obstetric Use

2014 ◽  
Vol 4 (3) ◽  
pp. 177-183
Author(s):  
Zaida Rahman ◽  
Asadul Mazid Helali
Keyword(s):  
Pregnant Women ◽  
Magnesium Sulfate ◽  
Preterm Labor ◽  
Safety Concern ◽  
Safety Information ◽  
Harmful Effect ◽  
The United States ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Magnesium sulfate (MgSO4) is the agent most commonly used for treatment of eclampsia and prevention of eclampsia in patients with severe pre-eclampsia. Another commonly practiced offlabel use of this drug is in preventing preterm labor in pregnant women where the duration of the treatment might be more than one week. It is usually given either by intramuscular or intravenous route. After administration, about 40% of plasma magnesium is bound with protein. The unbound magnesium ion diffuses into the extravascular extracellular space and then diffuses into bone. It also crosses the placenta and fetal membranes and then diffuses into the fetus and amniotic fluid. Magnesium is almost exclusively excreted in the urine; 90% of the dose is excreted during the first 24 hours after an intravenous infusion of MgSO4. The clinical effect and toxicity of MgSO4 can be linked to its concentration in plasma. A concentration of 1.8–3.0 mmol/L has been suggested for treatment of eclampsia. The actual magnesium dose and concentration needed for prophylaxis have never been estimated. Maternal toxicity is rare when MgSO4 is carefully administered and monitored. Deep tendon reflexes, respiratory rate, urine output and serum concentrations are the most common variables for monitoring the toxic effect. Currently the United States (US) Food and Drug Administration (FDA) is advising health care professionals against using MgSO4 injection for more than 5–7 days to stop preterm labor in pregnant women (off-label use). Administration of MgSO4 injection to pregnant women for more than 5–7 days may lead to low calcium levels and bone problems in the fetus, including osteopenia and fractures. The harmful effect in the fetus with the shortest duration is not established. In light of this new safety information, the drug label for MgSO4 injection, USP 50% has also been changed, including changing the pregnancy category to D from A and denoting the effect as “New teratogenic effects”. Similarly, the manufacturers of other MgSO4 injection products have made similar changes to their drug labels. In this review, the currently available knowledge of the pharmacokinetics of MgSO4 and its clinical usage for women with pre-eclampsia and eclampsia, its off-label use and safety concern regarding the warning announced by the FDA will be outlined. DOI: http://dx.doi.org/10.3329/jemc.v4i3.20957 J Enam Med Col 2014; 4(3): 177-183

scholarly journals Increasing off-label use of antipsychotic medications in the United States, 1995-2008

2011 ◽  
Vol 20 (2) ◽  
pp. 177-184 ◽  
Author(s):  
G. C. Alexander ◽  
S. A. Gallagher ◽  
A. Mascola ◽  
R. M. Moloney ◽  
R. S. Stafford
Keyword(s):  
United States ◽  
The United States ◽  
Off Label Use ◽  
Antipsychotic Medications ◽  
Off Label ◽  
Label Use

scholarly journals Off-label use of cancer therapies in women diagnosed with breast cancer in the United States

SpringerPlus ◽  
2015 ◽  
Vol 4 (1) ◽  
Author(s):  
Sophie Hamel ◽  
Douglas S McNair ◽  
Nicholas J Birkett ◽  
Donald R Mattison ◽  
Anthony Krantis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
United States ◽  
The United States ◽  
Cancer Therapies ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Off‐label use of prescription analgesics among hospitalized children in the United States

2020 ◽  
Vol 29 (4) ◽  
pp. 474-481
Author(s):  
Mary Carmack ◽  
Charles Berde ◽  
Michael C. Monuteaux ◽  
Shannon Manzi ◽  
Florence T. Bourgeois
Keyword(s):  
United States ◽  
The United States ◽  
Hospitalized Children ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Prescription trends of everolimus in non-elderly cancer patients with private insurance in the United States.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18016-e18016
Author(s):  
Yan Xing ◽  
Ying Xu ◽  
Funda Meric-Bernstam ◽  
Jenny Chee Ning Chang ◽  
Ya-Chen T. Shih
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Renal Cancer ◽  
Private Insurance ◽  
The United States ◽  
Secondary Malignancies ◽  
Off Label Use ◽  
Elderly Cancer Patients ◽  
Off Label ◽  
Label Use

e18016 Background: The use of targeted oral cancer medications has increased significantly since 2001. Everolimus, an mTOR inhibitor was first approved for cancer treatment by FDA as second line for patients with advanced renal cancer. Subsequently it has been approved for advanced pancreatic neuroendocrine tumor (NET) in 2011 and breast cancer in 2012 respectively. Off-label use is common in oncology practice. The objective of this study is to assess prescription trends, especially off-label use of everolimus, among non-elderly cancer patients with private insurance in the United States from 2009 to 2014. Methods: Data from the MarketScan database were analyzed. Between 2009 to 2014, 4,728 cancer patients with at least one everolimus prescription were included in the analyses. The diagnosis which incurred the most recently to the initial everolimus use in each calendar year was recorded. Off-label use was defined as using everolimus by all of the cancer types except of renal cancer in 2009-2014, NET in 2011-2014 and breast cancer in 2012-2014. Results: The number of patients received everolimus has increased significantly from 243 in 2009 to 1,194 in 2014. The most common diagnoses associated with everolimus use were breast cancer (42%), followed by renal cancer (24%), and NET (7%). Off-label use of everolimus increased from 29% in 2009 to 47% in 2011 then decreased to 23% in 2014. The 3 most common diagnoses associated with off-label use of everolimus were secondary malignancies (30.7%), breast cancer (10.4%) and liver cancer (5%) in 2009-2011, compared to secondary malignancies (47.3%), brain cancer (4.2%) and lung cancer (3.9%) in 2012-2014. The off-label use in female has decreased significantly from 32% in 2009 to 19% in 2014 (p = 0.03). There was no statistical difference in off-label use of everolimus by geographic region. Conclusions: Analyses of MarketScan data suggest off-label use of everolimus is common among US cancer patients, especially in lung, liver and brain cancer and secondary malignancies after the approved indication was expanded to breast cancer in 2012. Further research of the factors associated with off-label use of everolimus and its economic implication is needed.

Characterization of the Early Years of Bevacizumab Use for First-Line Treatment of Ovarian Cancer in the United States

2021 ◽  
pp. OP.20.00918
Author(s):  
Soledad Jorge ◽  
Barbara A. Goff ◽  
Heidi J. Gray ◽  
Daniel A. Enquobahrie ◽  
Kemi M. Doll
Keyword(s):  
United States ◽  
Ovarian Cancer ◽  
Metastatic Disease ◽  
The United States ◽  
Interquartile Range ◽  
Newly Diagnosed ◽  
Off Label Use ◽  
Off Label ◽  
Factors Associated ◽  
Label Use

PURPOSE: To quantify early dissemination patterns, factors influencing use, and costs of bevacizumab (BEV) for the treatment of newly diagnosed ovarian cancer (OC) in the United States before its regulatory approval for this indication (off-label use). METHODS: We identified women 18-65 years of age with newly diagnosed OC treated with surgery and platinum-based chemotherapy from 2008 to 2016 through the MarketScan database (N = 8,109). The proportion of women receiving BEV over time was calculated, multivariate logistic regression used to determine factors associated with BEV use, and total costs per cycle of chemotherapy with and without BEV abstracted. RESULTS: BEV utilization rose 1.8-fold during the study period, from 4.1% (2008) to 7.4 % (2016). BEV was used with non–platinum/taxane regimens over a third of the time (37.2%). Physician specialty (medical oncology v gyn oncology) and geography (southeast region) were significantly associated with higher rates of use. Clinical factors associated with BEV use were metastatic disease and presence of ascites. The median cost of one cycle of platinum/taxane chemotherapy plus BEV was $10,897 in US dollars (USD) (interquartile range $7,573-$18,133 USD), compared with $1,629 USD (interquartile range, $683.0-$4,461 USD) for platinum/taxane alone. CONCLUSION: Off-label use of BEV for newly diagnosed OC was rare (< 10%), but doubled following presentation of phase II and III data at international meetings. Both clinical (ascites, metastatic disease, and age) and nonclinical (specialty and region) factors were associated with BEV use, and its use was accompanied by a six-fold increase in the cost of one cycle of treatment.

scholarly journals Clinical outcomes with on-label and off-label use of the transcatheter heart valve in the United States

2014 ◽  
Vol 84 (1) ◽  
pp. 124-128 ◽  
Author(s):  
Joel A. Lardizabal ◽  
Conrad J. Macon ◽  
Brian P. O'Neill ◽  
Vikas Singh ◽  
Claudia A. Martinez ◽  
...  
Keyword(s):  
United States ◽  
Clinical Outcomes ◽  
Heart Valve ◽  
The United States ◽  
Off Label Use ◽  
Off Label ◽  
Transcatheter Heart Valve ◽  
Label Use

Trends in the “Off-Label” Use of GnRH Agonists Among Pediatric Patients in the United States

2018 ◽  
Vol 57 (12) ◽  
pp. 1432-1435 ◽  
Author(s):  
Carla M. Lopez ◽  
Daniel Solomon ◽  
Susan D. Boulware ◽  
Emily Christison-Lagay
Keyword(s):  
Precocious Puberty ◽  
Private Insurance ◽  
The United States ◽  
Annual Number ◽  
Gnrh Agonists ◽  
Off Label Use ◽  
Off Label ◽  
Number Of Children ◽  
Label Indication ◽  
Label Use

Background. Gonadotropin-releasing hormone (GnRH) agonists are FDA approved for the treatment of precocious puberty. The therapy consists of histrelin acetate (Supprelin), a surgically implanted device, or Lupron injections. In recent years, the use of these agents has been extended to include the off-label treatment of children with normally timed puberty. Trends in the off-label use of GnRH agonists in children across the U.S. have not been previously described in the literature. Methods. We analyzed data on the use of Supprelin and Lupron reported to the Pediatric Health Information System (PHIS) from 2013 to 2016 to determine the trends in both the FDA–approved and off-label uses of these medications. Results. We identified a stable cohort of 39 children’s hospitals administering GnRH agonist therapies from 2013 to 2016. During this period, the annual number of children treated with these medications for precocious puberty increased modestly, from 283 to 303; meanwhile, the fraction of children receiving therapy for an off-label indication more than doubled, from 12% (39 of 322 total patients) to 29% (125 of 428 total patients). Privately insured patients were more likely to be treated for an off-label indication (13%; 119 out of 883 patients) than Medicaid patients (8%; 58 out of 706 patients; χ2[1] = 10.97, P = .00093). Conclusion. From 2013 to 2016, the proportion of children treated with GnRH agonists for an off-label indication notably increased. The number of children treated for precocious puberty modestly increased. Private insurance coverage was associated with higher rates of off-label use.

Abstract 2563: Off Label Use Of Sirolimus Eluting Stent Increases The Rate Of Death And Stent Thrombosis Without Jeopardizing The Efficacy: Result Of The Evastent Matched Corhort Registry

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Aude Boignard ◽  
Alison Foote ◽  
Jean Louis Quesada ◽  
Mohamed Sahnoun ◽  
Nicolas Danchin ◽  
...  
Keyword(s):  
Stent Thrombosis ◽  
Safety Concern ◽  
Diabetic Patients ◽  
Off Label Use ◽  
Off Label ◽  
Risk Of Death ◽  
Sirolimus Eluting Stent ◽  
One Year ◽  
The One ◽  
Label Use

In everyday practice the off label use of DES is widespread, but are SES as effective in reducing the need for revascularisation when used on-label and do certain types of off-label use raise greater safety concerns? The EVASTENT nationwide matched cohort registry was designed to assess the efficacy and safety of the SES in diabetic patients with single or multiple vessel disease (SVD and MVD) compared to non-diabetic patients. 1731 pts were included (844 diabetic and 730 MVD patients). Although on-label use of SES was required patients presenting with various categories of off-label lesions were included. 428 (24% ) patients included and 514/ 2730 lesions (19%) treated were off-label: bifurcation lesions (n=182), lesions with thrombus (n=139), highly calcified lesions (n=134), ostial lesions (n=102), very long (>30 mm) lesions (n=15), left-main stenosis n=11), EF<0.30 (n=7). In 73 cases the lesion was off-label for more than one reason. Complete interim one year follow-up data are available for 98% of the patients and in October 2007 most patients will have been followed for 3 years. All MACES (cardiac death, non-fatal myocardial infarction and Stent thrombosis ST) have been evaluated by an independent critical events committee and cases of ST have been classified according to the ARC criteria. Results: off-label use was not more frequent in diabetic patients but occurred more often in MVD patients. Table 1 shows the one-year comparison between on and off-label use. Subgroup analysis suggests that highly calcified, bifurcation and ostial lesions are particularly at risk for ST. In multivariate analysis off-label use remained an independent predictor of death and the occurrence of MACEs. Conclusion: Off-label use of SES does not reduce the efficacy of the SES, but increases the risk of death and ST. This safety concern must be taken into consideration when designing studies to evaluate new indications for these DES. On and Off-Label comparison

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