Published Case Reports (published + case_report)

Distribution by Scientific Domains


Selected Abstracts


Treatment of lentigo maligna with topical imiquimod

BRITISH JOURNAL OF DERMATOLOGY, Issue 2003
M.F. Naylor
Summary A published case report and anecdotal experience suggested that topical imiquimod is an effective treatment for stage 0 melanoma (lentigo maligna). To gauge the efficacy of this therapy, we undertook a trial of topical imiquimod in 30 subjects with histologically confirmed lentigo maligna. Thirty subjects with lentigo maligna were recruited for an open-labelled efficacy trial with daily topical application of imiquimod 5% cream for 3 months. Study subjects were enrolled from the Dermatology service of the University of Oklahoma, the Oklahoma City Veteran's Administration Hospital Dermatology service and from referrals for the study from other practitioners. In order to determine an initial response rate, a four-quadrant biopsy was carried out on all patients 1 month after cessation of treatment, targeting the most clinically and dermatoscopically suspicious areas. Of 28 evaluable subjects who have completed the 3-month treatment phase, 26 (93%) were complete responders and two were treatment failures at the time of the 4-quadrant biopsy. Over 80% of the 28 subjects that completed treatment have been followed for more than 1 year with no relapses. The results of this study demonstrate that topical imiquimod produces a high complete response rate in lentigo maligna when applied daily for 3 months. [source]


Oestrogen withdrawal associated psychoses

ACTA PSYCHIATRICA SCANDINAVICA, Issue 5 2001
V. Mahé
Objective: Oestrogen withdrawal has been hypothesized as playing a causal role in puerperal psychoses. However, oestrogen withdrawal exists in conditions others than puerperium. We searched the published case reports where a decrease in oestrogen levels not occurring during puerperium was associated with a psychotic disorder, in order to evaluate the relevance of this hypothesis. These cases were defined as oestrogen withdrawal associated psychoses. Method: A systematic research of the literature was conducted for the period 1960,2000. Results: We identified 26 observations reporting an association between a psychotic disorder and a phase of oestrogen withdrawal. Psychotic episodes were short and reversible with recurrences reported when oestrogen withdrawal recurred. Puerperal psychosis was frequently reported in the history of patients. Conclusion: The oestrogen withdrawal hypothesis can be extended to certain psychotic episodes not occurring during in puerperium. This provides an additional argument for the clinical relevance of oestrogen withdrawal in puerperal and related psychoses. [source]


Methemoglobinemia Following Transesophageal Echocardiography: A Case Report and Review

ECHOCARDIOGRAPHY, Issue 4 2006
Swarnalatha BheemReddy M.D.
Benzocaine (ethyl aminobenzoate) is a topical anesthetic widely used for oropharyngeal anesthesia prior to transesophageal echocardiography (TEE). Topical anesthetics have been reported to cause methemoglobinemia, but this adverse event is extremely rare and has not been listed as one of the possible complications of TEE. However, recently the number of published case reports of TEE-associated methemoglobinemia has increased. Since its first description in 1950, 65 cases of methemoglobinemia have been reported including a recent report of five cases from a single center. Physicians who are not familiar with the association of TEE with benzocaine-induced methemoglobinemia may not recognize the idiosyncratic and often nonspecific characteristic of this condition. Recognition is critical, however, since left untreated methemoglobinemia can lead to cardiopulmonary compromise, neurological sequelae, and even death. The current report documents an additional case of TEE-associated methemoglobinemia from a high-volume (8000 cases /year including 400,450 TEE/year) echo lab. A review of the literature suggests that this complication may be more prevalent, than generally appreciated. This case report emphasizes the importance of appropriate dose, recognition, and the treatment of this entity to cardiologists performing TEE. [source]


Nordic guidelines for neuraxial blocks in disturbed haemostasis from the Scandinavian Society of Anaesthesiology and Intensive Care Medicine

ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 1 2010
H. BREIVIK
Background: Central neuraxial blocks (CNBs) for surgery and analgesia are an important part of anaesthesia practice in the Nordic countries. More active thromboprophylaxis with potent antihaemostatic drugs has increased the risk of bleeding into the spinal canal. National guidelines for minimizing this risk in patients who benefit from such blocks vary in their recommendations for safe practice. Methods: The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI) appointed a task force of experts to establish a Nordic consensus on recommendations for best clinical practice in providing effective and safe CNBs in patients with an increased risk of bleeding. We performed a literature search and expert evaluation of evidence for (1) the possible benefits of CNBs on the outcome of anaesthesia and surgery, for (2) risks of spinal bleeding from hereditary and acquired bleeding disorders and antihaemostatic drugs used in surgical patients for thromboprophylaxis, for (3) risk evaluation in published case reports, and for (4) recommendations in published national guidelines. Proposals from the taskforce were available for feedback on the SSAI web-page during the summer of 2008. Results: Neuraxial blocks can improve comfort and reduce morbidity (strong evidence) and mortality (moderate evidence) after surgical procedures. Haemostatic disorders, antihaemostatic drugs, anatomical abnormalities of the spine and spinal blood vessels, elderly patients, and renal and hepatic impairment are risk factors for spinal bleeding (strong evidence). Published national guidelines are mainly based on experts' opinions (weak evidence). The task force reached a consensus on Nordic guidelines, mainly based on our experts' opinions, but we acknowledge different practices in heparinization during vascular surgery and peri-operative administration of non-steroidal anti-inflammatory drugs during neuraxial blocks. Conclusions: Experts from the five Nordic countries offer consensus recommendations for safe clinical practice of neuraxial blocks and how to minimize the risks of serious complications from spinal bleeding. A brief version of the recommendations is available on http://www.ssai.info. [source]


Acute suicidality after commencing atomoxetine

JOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 10 2008
Georgia Armat Paxton
Abstract: An 11 year old boy developed acute agitation and suicidal ideation after commencing atomoxetine shortly after it was approved for use in Australia. The clinical features were similar to reactions described in response to selective serotonin reuptake inhibitors. The case highlights the importance of close monitoring when starting newly registered medications. An increased risk of suicidal thinking was subsequently identified for this drug leading to a Food and Drug Administration alert and a boxed warning in September 2005, however there are still no other published case reports of acute suicidality. [source]


Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activity

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 10 2004
L. M. Aledort
Summary. Thrombosis is a rare but well-recognized potential complication of Factor VIII Inhibitor Bypass Activity (FEIBA) infusion. Recombinant factor VIIa (rFVIIa) is increasingly used as an alternative to FEIBA; however, the thrombotic safety profile of rFVIIa remains incompletely characterized. To determine the incidence rates of thrombotic adverse events (AEs) after infusion of rFVIIa and FEIBA. Data from the MedWatch pharmacovigilance program of the US Food and Drug Administration, as supplemented by published case reports, were used in conjunction with estimated numbers of infusions available from manufacturers to assess comparative incidence of thrombotic AEs in patients receiving rFVIIa or FEIBA in the period from April 1999 through June 2002. Reported thrombotic AEs were rare, with incidence rates of 24.6 per 105 infusions (CI, 19.1,31.2 per 105 infusions) for rFVIIa and 8.24 per 105 infusions (CI, 4.71,13.4 per 105 infusions) for FEIBA. Thrombotic AEs were significantly more frequent in rFVIIa than FEIBA recipients (incidence rate ratio, 2.98; CI, 1.71,5.52). The most commonly documented single type of thrombotic AE after rFVIIa infusion was cerebrovascular thrombosis, while myocardial infarction was the most frequent type in patients receiving FEIBA. Contrasting AE reporting patterns between rFVIIa and FEIBA may have contributed to the observed difference in thrombotic event incidence. Nevertheless, this comprehensive pharmacovigilance assessment does not support superior thrombotic safety of rFVIIa and suggests that thrombotic AE risk may be higher in rFVIIa than FEIBA recipients. [source]


Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2010
John A. Clark MD
Abstract Purpose To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006. Methods Forty-one spontaneous AE reports were summarized for reported AE profile and chronological reporting patterns. Each AE report was adjudicated by a hematologist for the topical bovine thrombin product that was given and the AE(s) that were reported. AEs were grouped as allergic, coagulopathy/bleeding, and all other AEs combined. Grouped AE serial analyses were carried out using successive 3-year time increments between 1986 (the year an AE report was first noted for a bovine thrombin product) and 2006 (the first full year that was available at the time of initiation of the data summary). Main outcome measures The primary outcome measures were every 3-year trend lines for all-AE reports, all reporters, and topical bovine thrombin brand mentions for 2 AE groups of interest (allergic events and coagulopathy/bleeding events). Results The all-AE spontaneous reporter trend showed a downward appearance for AE reporting activity that started in 1995,1998 and continued through 2004,2006. The all-AE reports trend showed two potential safety signals that could be identified serially: (1) a prominent 1989,1991 peak that was attributable to allergic events (in particular, anaphylaxis), and (2) a small 1995,2000 broad peak that was attributable in part to coagulopathy/bleeding events. Allergic events were predominantly reported with products approved prior to 1995, were not temporally associated with prior medical literature case reports, and continued to be forwarded to the FDA at low levels up to the end of this study in 2006. Coagulopathy/bleeding events were reported only with products approved prior to 1995, were temporally associated with medical literature case reports, and were not forwarded to the FDA after 2000. Conclusions Overall, spontaneous AE reporting for topical bovine thrombin occurs at very low levels, and appears to have been decreasing since 1995. The serial reporting patterns for topical bovine thrombin are best explained as a strong safety signal for allergic events with ongoing, low level reporting, and a weak safety signal for coagulopathy/bleeding events that ceased on or before 2000. Although this descriptive trend analysis cannot measure associations or causation, the coagulopathy/bleeding signal may have been prompted by multiple, antecedent published case reports. The subsequent diminishment of signal attributed to thrombin likewise may coincide with lack of such reporting in larger follow-up clinical trials or, alternatively, in the introduction and growing market share of thrombin brands of greater purity. Currently marketed topical bovine thrombin formulations are rarely volunteered as possible causes of adverse events. Copyright © 2009 John Wiley & Sons, Ltd. [source]


Inherited and de novo von Willebrand disease ,Vicenza' in UK families with the R1205H mutation: diagnostic pitfalls and new insights

BRITISH JOURNAL OF HAEMATOLOGY, Issue 1 2006
William A. Lester
Summary von Willebrand disease (VWD) caused by the R1205H mutation has distinct and reproducible clinical and laboratory features. This report describes the phenotypic and molecular investigation of seven kindreds with VWD Vicenza R1205H. All affected individuals have historically been diagnosed with moderate to severe type 1 VWD. Amongst all families with highly penetrant type 1 VWD investigated at our centre, heterozygosity for the R1205H mutation was found to be the most common underlying molecular defect. A severe laboratory phenotype associated with a bleeding history that was milder than expected was commonly observed, consistent with previous published case reports; however, abnormal ultralarge high molecular weight multimers were not detected in resting plasma samples. We also provide evidence that the R1205H mutation may arise de novo, evidence that a common genetic origin for this mutation is unlikely. [source]