Teratogenic Risk of Statins in Pregnancy

2012 ◽  
Vol 46 (10) ◽  
pp. 1419-1424 ◽  
Author(s):  
Laura M Godfrey ◽  
John Erramouspe ◽  
Kevin W Cleveland
Keyword(s):  
Case Reports ◽  
Data Extraction ◽  
Current Trend ◽  
Case Series ◽  
Teratogenic Risk ◽  
Study Selection ◽  
Pubmed Search ◽  
Teratogenic Potential ◽  
Statin Use ◽  
In Pregnancy

Objective: To evaluate the teratogenic potential of statins in women of child-bearing age. Data Sources: A PubMed search (1980-September 2012) was performed using the search terms statin and pregnancy, then repealed using statin and teratogenicity. Results were limited to articles published in English reporting on use of statins in humans. Study Selection and Data Extraction: All articles presenting data on pregnancy outcomes after statin use during any trimester of pregnancy were included. Three case reports, 2 case series, 2 systematic reviews, 2 registry-based studies, and 1 prospective observational cohort study were reviewed. Data Synthesis: Since initial premarketing studies of lovastatin in animals, terato-genesis has been assumed to be a classwide function of statins' mechanism of action. Data from human exposure during pregnancy have been gathered and analyzed in a variety of study formats to formulate useable conclusions on statins' actual teratogenic risk and pattern of associated birth defects. Although the current trend is that actual risk is lower than once thought, the available literature is limited by potential reporting bias, contains overlap in the data, and frequently lacks numbers of total exposures to statins during pregnancy with reported malformations. Additionally, no human studies included data on the 2 newest statins (rosuvastatin, pitavastatin); the more lipophilic statins (lovastatin, simvastatin) have the most experience and thus have more evidence related to teratogenic potential. Conclusions: Human teratogenic risk has not been proven nor has it been ruled out by the available data on statin use in pregnancy. Possible differences in risk between individual statins require further evaluation. Additional data, including prospective observational cohorts with inadvertent maternal exposure to statins during early weeks of gestation, should further help to clarify appropriate recommendations for statin use in this population.

Drug-Induced Restless Legs Syndrome

2018 ◽  
Vol 52 (7) ◽  
pp. 662-672 ◽  
Author(s):  
Edna Patatanian ◽  
Melanie K. Claborn
Keyword(s):  
Restless Legs Syndrome ◽  
English Language ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Predisposing Factors ◽  
Drug Induced ◽  
Restless Legs ◽  
Drug Classes ◽  
Study Selection

Objective: To review the literature on drug-induced restless legs syndrome (DI-RLS). Data Sources: The review included a search for English-language literature from 1966 to December 2017 in the MEDLINE, PubMed, and Ovid databases using the following search terms: restless legs syndrome (RLS), periodic limb movement, adverse effects, and drug-induced. In addition, background articles on the pathophysiology, etiology, and epidemiology of RLS were retrieved. Bibliographies of relevant articles were reviewed for additional citations. Study Selection and Data Extraction: All case reports, case series, and review articles of DI-RLS were identified and analyzed. There were only a small number of controlled clinical trials, and most data were from case reports and case series. Results: Several drugs and drug classes have been implicated in DI-RLS, with antidepressants, antipsychotics, and antiepileptics having the most evidence. In addition, RLS may be linked with a number of disorders or underlying predisposing factors as well. Conclusions: The prevalence of RLS is variable and ranges from 3% to 19% in the general population. There are many predisposing factors to RLS, but an emerging body of evidence suggests that there is an association between numerous drugs and RLS.

scholarly journals Emergency Management of Paraphimosis

2003 ◽  
Vol 10 (4) ◽  
pp. 253-257 ◽  
Author(s):  
Ch Chung
Keyword(s):  
Case Reports ◽  
Data Extraction ◽  
Treatment Options ◽  
Case Series ◽  
Treatment Modalities ◽  
Invasive Treatment ◽  
Manual Search ◽  
Study Selection ◽  
Library Network ◽  
Randomised Controlled

Objective To review the treatment modalities available for paraphimosis, with special emphasis on those applicable to the emergency department. Data source Relevant medical literature was searched through MEDLINE, EMBASE, CINAHL, and Cochrane Database. Manual search was performed in books on Urology, General Surgery and Emergency Medicine available in the Hospital Library. Further information was obtained through the Internet at < www.infoseek.com >. References cited in articles were also retrieved. Study selection Key words for the literature, Internet and textbook search were ‘paraphimosis’ and ‘treatment’. All available years of study were reviewed. Data extraction Relevant full text articles were obtained through the hospital library network. Original articles, review papers, medical practice, case reports, and relevant book chapters were reviewed. Data synthesis There were no prospective, randomised, controlled studies available. The majority were case series and expert experience or opinions only. Currently, a multitude of non-invasive and invasive treatment options are available, including manual reduction, help of non-crushing tissue forceps, puncture technique and dorsal slit. Conclusion All treatment methods are within the capability of the emergency physician. Hospitalization should rarely be required, unless there are serious complications.

Sulfonamide Cross-Reactivity: Fact or Fiction?

2005 ◽  
Vol 39 (2) ◽  
pp. 290-301 ◽  
Author(s):  
Kelly K Johnson ◽  
David L Green ◽  
Jason P Rife ◽  
Lynn Limon
Keyword(s):  
Case Reports ◽  
Data Extraction ◽  
Drug Hypersensitivity ◽  
Package Insert ◽  
Case Series ◽  
Cross Reactivity ◽  
Level Of Evidence ◽  
Mesh Terms ◽  
Pubmed Search ◽  
The Individual

OBJECTIVE: To provide a critical and comprehensive review of the literature, specifically case reports and observational studies used to support the concept of cross-reactivity between sulfonylarylamines and non-sulfonylarylamines. DATA SOURCES: A list of medications was formulated from several different review articles. A MEDLINE/PubMed search was conducted (1966–March 2004) using the individual medications and the MeSH terms of drug hypersensitivity/etiology, sulfonamides/adverse effects, and/or cross-reaction. STUDY SELECTION AND DATA EXTRACTION: A critical review of the methodology and conclusions for each article found in the search was conducted. The manufacturer's package insert (MPI) for each drug was examined for a statement concerning possible cross-reactivity in patients with a sulfonamide allergy. If indicated, the manufacturers were contacted to obtain any clinical data supporting the statement. DATA SYNTHESIS: A total of 33 medications were identified. Seventeen (51.5%) of the MPIs contained statements of varying degrees concerning use in patients with a “sulfonamide” allergy; 21 case series, case reports, and other articles were found. CONCLUSIONS: After a thorough critique of the literature, it appears that the dogma of sulfonylarylamine cross-reactivity with non-sulfonylarylamines is not supported by the data. While many of the case reports on the surface support the concept of cross-reactivity, on closer examination the level of evidence in many of the cases does not conclusively support either a connection or an association between the observed cause and effect.

Lacosamide for the Treatment of Refractory Status Epilepticus

2011 ◽  
Vol 45 (11) ◽  
pp. 1445-1449 ◽  
Author(s):  
Erica M Fernandez ◽  
Andrew J Franck
Keyword(s):  
Status Epilepticus ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Refractory Status Epilepticus ◽  
Current Evidence ◽  
Refractory Status ◽  
Successful Termination ◽  
Study Selection ◽  
Animal Data

Objective: To evaluate current evidence for the use of lacosamide in the treatment of refractory status epilepticus. Data Sources: Literature was accessed via PubMed (through July 2011) using the terms lacosamide and status epilepticus. Study Selection and Data Extraction: All reports on the use of lacosamide in patients with status epilepticus were included for evaluation. Reviews and animal data were excluded. Data Synthesis: Treatment of status epilepticus is challenging, and most patients fail to respond to initial treatment. Recently, several reports have been published on the use of lacosamide for status epilepticus. Eleven reports (5 case reports and 6 case series) were identified. Lacosamide was credited with successful termination of status epilepticus in a majority of these reports, However, the data are weakened by the heterogeneity of the reports, their descriptive nature, and the common divergence from current recommendations for the treatment of status epilepticus, Conclusions: While lacosamide has been reported as an effective treatment for refractory status epilepticus, there is insufficient evidence for its routine use. For cases in which the risks associated with anesthetizing drugs are believed to outweigh the benefits, such as in complex partial status epilepticus, lacosamide may be a reasonable option after more established drug therapies fail.

Ectopic ACTH- and/or CRH-Producing Pheochromocytomas

2020 ◽  
Author(s):  
Patrick F Elliott ◽  
Thomas Berhane ◽  
Oskar Ragnarsson ◽  
Henrik Falhammar
Keyword(s):  
Cushing Syndrome ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Term Outcome ◽  
Ectopic Acth ◽  
Long Term Outcome ◽  
Study Selection ◽  
Data Source ◽  
Ectopic Adrenocorticotropic Hormone

Abstract Context The characteristics of catecholamine-secreting pheochromocytomas have been well studied. However, less is known about the characteristics, management and outcome in patients with ectopic adrenocorticotropic hormone (ACTH) and/or corticotrophin-releasing hormone (CRH)-secreting pheochromocytomas. Objective To review the characteristics and outcomes of ACTH- and/or CRH-secreting pheochromocytomas. Data Source A systematic search of PubMed/MEDLINE and Web of Science, identifying relevant reports published up to 10 February 2020. Study Selection Original articles, including case reports and case series, reporting individual patient data from patients with ACTH- and/or CRH-secreting pheochromocytomas. Data extraction Information on sex, age, symptoms at presentation, comorbidities, biochemistry, imaging, histopathology, and outcomes was extracted. Data Synthesis We identified 91 articles reporting on 99 cases of ACTH- and/or CRH-secreting pheochromocytomas (CRH-secreting n = 4). Median age at diagnosis was 49 years (interquartile range 38-59.5) with a 2:1 female to male ratio. Most patients presented with clinical Cushing syndrome (n = 79; 81%), hypertension (n = 87; 93%), and/or diabetes (n = 50; 54%). Blood pressure, glucose control, and biochemical parameters improved in the vast majority of patients postoperatively. Infections were the most common complication. Most cases (n = 70, 88%) with reported long-term outcome survived to publication (median follow-up 6 months). Conclusion Ectopic ACTH- and/or CRH-secreting pheochromocytoma should be considered in patients presenting with ACTH-dependent Cushing syndrome and adrenal mass. Despite the challenge in diagnosis, patient outcomes appear favorable.

LInezolid for the Treatment of Nocardia spp. Infections

2007 ◽  
Vol 41 (10) ◽  
pp. 1694-1699 ◽  
Author(s):  
Tomasz Z Jodlowski ◽  
Igor Melnychuk ◽  
John Conry
Keyword(s):  
Case Reports ◽  
Data Extraction ◽  
Central Nervous System Involvement ◽  
Case Series ◽  
Published Data ◽  
Data Synthesis ◽  
Study Selection ◽  
Disseminated Disease

Objective: To review the available evidence regarding the use of linezolid for the treatment of Nocardia spp. infections. Data Sources: Data were identified through a search of MEDLINE (1966-May 2007), American Search Premier (1975-May 2007), International Pharmaceutical Abstracts (1960-2007), Science Citation Index Expanded (1996-2007), and Cochrane Databases (publications archived until May 2007) using the terms linezolid and Nocardia. Study Selection and Data Extraction: Prospective and retrospective studies, case reports, case series, and in vitro studies were eligible for inclusion if they used linezolid for nocardiosis regardless of site of infection and outcome. Data Synthesis: We identified 11 published cases of linezolid use for Nocardia spp. infections. The predominant species isolated were N. asteroides (n=4; 36%) and N. farcinica (n= 3; 27%). Nocardiosis with central nervous system involvement (n= 7; 64%) or disseminated disease (n= 4; 36%) were most common. The main reason for discontinuation of previous antimicrobials was most often related to adverse effects (n= 5; 45%), followed by clinical failure (n = 3; 27%). Linezolid was associated with cure or improvement in all cases (n =11; 100%). However, the majority of patients developed serious complications that may have led to premature discontinuation of therapy with linezolid, including myelosuppression (n = 5; 45%) or possible/confirmed peripheral neuropathy (n = 2; 18%). Conclusions: The limited published data suggest that linezolid appears to be an effective alternative to trimethoprim/sulfamethoxazole for the treatment of nocardiosis. Unfortunately, the high cost and potentially serious long-term toxicities of linezolid appear to limit its use and relegate it to salvage therapy alone or in combination with other antimicrobials.

Lead in Mineral or Multivitamin-Multimineral Products

2021 ◽  
pp. 106002802110233
Author(s):  
C. Michael White
Keyword(s):  
English Language ◽  
Data Extraction ◽  
The United States ◽  
Third Party ◽  
Reference Level ◽  
Study Selection ◽  
Pubmed Search ◽  
Zinc Supplements ◽  
Average Lead ◽  
Year 2000

Objective Assess the current daily interim reference level of lead and the amount contained in current mineral and multivitamin-multimineral (MVM) products. Data Sources PubMed search from 1980 to May 15, 2021, limited to the English language, via the search strategy ((mineral OR multivitamin OR calcium OR iron OR magnesium OR copper OR zinc OR chromium OR selenium) AND (heavy metals OR Pb OR lead)). Study Selection and Data Extraction Narrative review of studies assessing lead content in mineral or MVM products. Data Synthesis Products containing different calcium forms (dolomite, bone meal, natural carbonate) have historically had higher lead levels than others (refined carbonate, lactate, gluconate, acetate, sevelamer), but the gap has closed considerably since the year 2000. Although only limited assessments of magnesium and zinc supplements have been conducted, no alarming average lead amounts were found. MVM products assessed since 2007 had low median or mean lead concentrations. However, large interproduct differences exist, with many products having very little lead and some products having concerning amounts. Relevance to Patient Care and Clinical Practice It is difficult for pharmacists and consumers to know the amount of lead in an actual product unless it is tested in an independent third-party lab. The United States Pharmacopeia and NSF International will provide a seal on the products stating that the products have a low level of lead, but even so, children could receive more lead than the Food and Drug Administration’s Interim Reference Level. Conclusions The threat from lead exposure in mineral and MVM products have diminsihed considerably over time but some products can still have excessive amounts. Without third-party testing, it is difficult for clinicians and consumers to know which outlier products to avoid.

scholarly journals Manipulative and Manual Therapies in the Management of Patients with Prior Lumbar Surgery: A Systematic Review

2020 ◽  
Author(s):  
Clinton J Daniels ◽  
Zachary A. Cupler ◽  
Jordan A Gliedt ◽  
Sheryl Walters ◽  
Alec L Schielke ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Clinical Decision Making ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Clinical Decision ◽  
Manual Therapies ◽  
Lumbar Surgery ◽  
Pilot Studies ◽  
Surgical Interventions

Abstract BackgroundThe purpose was to identify, summarize, and rate scholarly literature that describes manipulative and manual therapy following lumbar surgery.MethodsThe review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and was registered with PROSPERO. PubMed, Cochrane Database of Systematic Reviews, ICL, CINAHL, and PEDro were searched through July 2019. Articles were screened independently by at least two reviewers for inclusion. Articles included described the practice, utilization, and/or clinical decision making to post surgical intervention with manipulative and/or manual therapies. Data extraction consisted of principal findings, pain and function/disability, patient satisfaction, opioid/medication consumption, and adverse events. Scottish Intercollegiate Guidelines Network critical appraisal checklists were utilized to assess study quality.ResultsLiterature search yielded 1916 articles, 348 duplicates were removed, 109 full-text articles were screened and 50 citations met inclusion criteria. There were 37 case reports/case series, 3 randomized controlled trials, 3 pilot studies, 5 systematic/scoping/narrative reviews, and 2 commentaries. ConclusionThe findings of this review may help inform practitioners who utilize manipulative and/or manual therapies regarding levels of evidence for patients with prior lumbar surgery. Following lumbar surgery, the evidence indicated inpatient neural mobilization does not improve outcomes. There is inconclusive evidence to recommend for or against most manual therapies after most surgical interventions.Trial registrationProspectively registered with PROSPERO (#CRD42020137314). Registered 24 January 2020.

Risk of Gastrointestinal Bleeding on Treatment With Statin Alone or With Concomitant Administration of Warfarin: A Systematic Review and Meta-analysis of 5.3 Million Participants

2021 ◽  
pp. 106002802110497
Author(s):  
Akshaya Srikanth Bhagavathula ◽  
Kota Vidyasaga ◽  
Eyob Alemayehu Gebreyohannes ◽  
Wubshet Tesfaye
Keyword(s):  
Gastrointestinal Bleeding ◽  
Observational Studies ◽  
Data Extraction ◽  
Meta Analysis ◽  
Concomitant Administration ◽  
Pooled Analysis ◽  
Data Synthesis ◽  
Study Selection ◽  
Statin Monotherapy ◽  
Statin Use

Objective: This study aimed to comprehensively evaluate the risk of gastrointestinal bleeding (GIB) with statin monotherapy or with concomitant warfarin use. Data Sources: PubMed, Web of Science, and EMBASE (via Scopus) were searched for observational studies that reported the risk of GIB in adults on statin therapy or with concomitant warfarin use until August 28, 2021. Study Selection and Data Extraction: Observational studies evaluating the risk of GIB in adults (age >18 years) on statin medication or concomitant use with warfarin were included. Data Synthesis: In all, 14 studies with a total of 5 235 123 participants, reporting 48 677 GIB events (43 734 from statin users and 4943 from users of statin combined with warfarin), were included in the analyses. The pooled analysis revealed no difference in the risk of GIB with statin monotherapy (relative risk [RR]: 0.65; 95% CI: 0.42-1.02) or concomitant statin + warfarin use (RR: 0.97; 95% CI: 0.91-1.02). Prior use of statin was not associated with GIB risk (RR: 0.88; 95% CI: 0.63-1.22), whereas a shorter duration of statin use (<5 years) was associated with a lower risk of GIB (RR: 0.42; 95% CI: 0.18-0.97). Relevance to Patient Care and Clinical Practice: This analysis provides strong evidence on the association between statin use (with/without warfarin) and risk of GIB. Conclusion: Statin alone or combined with warfarin was not significantly associated with either an increased or decreased risk of GIB. The GIB risk was significantly lower when statins were used for a short duration (<5 years). The putative relationship between statins and GIB in warfarin users warrant further investigation.

A Review and Assessment of Drug-Induced Thrombocytosis

2018 ◽  
Vol 53 (5) ◽  
pp. 523-536 ◽  
Author(s):  
Quyen T. Vo ◽  
Dennis F. Thompson
Keyword(s):  
English Language ◽  
Web Of Science ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Search Term ◽  
Drug Induced ◽  
Reactive Thrombocytosis ◽  
All Trans Retinoic Acid ◽  
Mesh Terms

Objectives: The purpose of this article is to review the current literature on drug-induced thrombocytosis with the goal of critically assessing causality and providing a comprehensive review of the topic. Thrombopoietic growth factors, such as thrombopoietin-receptor agonists (romiplostim and eltrombopag) and erythropoietin are not included in our review. Data Sources: The literature search included published articles limited to the English language and humans in MEDLINE, EMBASE, and Web of Science databases. MEDLINE/PubMed (1966 to September 2018) was searched using the MeSH terms thrombocytosis/chemically-induced and thrombocytosis/etiology. EMBASE (1980 to September 2018) was searched using the EMTAGS thrombocytosis/side effect. Web of Science (1970 to September 2018) was searched using the search term thrombocytosis. References of all relevant articles were reviewed for additional citations and information. Study Selection and Data Extraction: Review articles, clinical trials, background data, case series, and case reports of drug-induced thrombocytosis were collected, and case reports were assessed for causality using a modified Naranjo nomogram. Data Synthesis: Drug-induced thrombocytosis, a form of reactive thrombocytosis cannot be easily differentiated from more common etiologies of reactive thrombocytosis. In all, 43 case reports of drug-induced thrombocytosis from a wide variety of drugs and drug classes were reviewed using a modified Naranjo probability scale that included criteria specific for thrombocytosis. Conclusions: Drug-induced thrombocytosis is a relatively rare adverse drug reaction. The strongest evidence of causality supports low-molecular-weight heparins and neonatal drug withdrawal. Weaker evidence exists for all-trans retinoic acid, antibiotics, clozapine, epinephrine, gemcitabine, and vinca alkaloids.

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