Defence Engagement (Health) between the UK and Ireland since the Good Friday Agreement in 1998.

This paper describes the range of Defence Engagement (Health) (DE(H)) activities between Northern Ireland and Ireland following the Good Friday Agreement in April 1998. Although the Agreement made provision for cross-border cooperation in health, the Omagh bombing of August 1998 energised the discussion to provide greater co-ordination of future responses to mass casualty events. The paper describes these DE(H) activities at the Strategic, Operational and Tactical levels to show the integration across these levels and between the agencies of both governments. The paper shows how a DE(H) programme can have a successful strategic effect by finding topics of mutual interest that can bring together two countries in order to provide an effective health and social care provision. This paper forms part of a special issue of BMJ Military Health dedicated to Defence Engagement (.

A Proton Pump Inhibitor in the Reformulation Setting: Bioequivalence and Potential Implications for Long-Term Safety.

Proton pump inhibitors (PPIs) have become known for both their therapeutic effect and good safety profile. An application was submitted to the US Food and Drug Administration for approval of a reformulated PPI product that failed bioequivalence testing, but was submitted on the basis of the long history of PPI use as a "surrogate" for equivalence. This review evaluates the safety data for PPIs, discuss variability of pharmacokinetic parameters of PPIs in the reformulation setting, and potential implications of those changes for long-term safety.

Assessment of hot flushes and vaginal dryness among obese women undergoing bariatric surgery.

OBJECTIVE: Menopausal symptoms are associated with a negative impact on the quality of life, leading women to seek medical treatment. Obesity has been linked to higher levels of menopausal symptoms such as hot flushes. This assessment will explore whether the prevalence and bother of hot flushes and vaginal dryness change from pre- to post-bariatric surgery among obese midlife women. METHODS: This study is a longitudinal analysis of data from 69 women (ages 35-72 years) undergoing bariatric surgery with reported reproductive histories and menopausal symptoms at preoperative and 6-month postoperative visits. Prevalence of and degree of bother of hot flushes and vaginal dryness at pre- and post-surgery were compared using McNemar's test and Wilcoxon signed-rank test. RESULTS: The reported degree of bother of symptoms associated with hot flushes decreased from pre- to post-surgery (p < 0.01). There was no significant change in the prevalence of hot flushes or vaginal dryness in the overall study sample. CONCLUSIONS: The degree of bother of symptoms associated with hot flushes among midlife women may decrease after bariatric surgery. These results highlight important secondary gains, including less bothersome menopausal symptoms, for women who choose bariatric surgery for weight loss.

Occult vs. overt upper gastrointestinal bleeding - inverse relationship and the use of mucosal damaging and protective drugs.

BACKGROUND: While efforts have focused on the prevention of overt upper gastrointestinal bleeding (UGIB), little is known about occult GIB, which might also originate from sites not protected by acid inhibition. AIM: To measure the incidence and outcomes of both overt and occult GIB over a 6-year period (2007-2012), and to assess the use of NSAIDs, anti-thrombotic therapy (ATT), proton pump inhibitors (PPIs), and iron therapy. METHODS: A sample of 300 patients (100 from each of three index years) with occult GIB was randomly selected and their outcomes were compared with those of patients with overt UGIB (N = 869). RESULTS: The incidence of overt UGIB fell from 140.1 per 100 000 population per annum in 2007 to 106.8 in 2010 and to 88.0 in 2012 (P < 0.001); while that of occult GIB rose from 243.1 to 263.6 and to 292.8 (P < 0.001) over the same period. The incidence of occult GIB was highly correlated with the number of prescriptions of PPIs per 1000 population (χ(2) trend = 11.80; P < 0.001). In the overt UGIB group, the median haemoglobin level on presentation was lowest (10.3) in patients taking NSAIDs/ATT plus PPIs compared with those taking PPIs alone (11.5), NSAIDs/ATT alone (10.4) or none of these drugs (12.7 g/dL) (P < 0.001, Kruskal-Wallis). CONCLUSIONS: An inverse trend seems to have formed in the incidence of overt vs. occult gastrointestinal bleeding in association with the wider use of PPIs and NSAIDs. An alternative approach to acid inhibition is needed to prevent gastrointestinal bleeding.

A national survey of independent living donor advocates: the need for practice guidelines.

In 2000, representatives of the transplant community convened for a meeting on living donation in an effort to provide recommendations to promote the welfare of living donors. One key recommendation included in the consensus statement was that all transplant centers which have performed living donor surgeries have an independent living donor advocate (ILDA) "whose only focus is on the best interest of the donor." The aims of this study were to begin to understand the sociodemographic characteristics, selection and training, and clinical practices of ILDAs. All US transplant centers performing living donor surgeries were contacted to identify the ILDA at their center. One hundred and twenty ILDAs completed an anonymous survey. Results indicated considerable variability with regard to the sociodemographic characteristics of ILDAs, how the ILDA was selected and trained, and the ILDAs' clinical practices, particularly ethical challenges encountered by ILDAs. The variability observed may result in differential selection of donors and could have a potential negative impact on the lives of both donors and transplant candidates. The variability in the background, training, and practice of ILDAs suggests the need for strategies, such as practice guidelines, to standardize the interaction between ILDAs and living donors.

Clinical trial: the incidence and early mortality after peptic ulcer perforation, and the use of low-dose aspirin and nonsteroidal anti-inflammatory drugs.

BACKGROUND: It is not clear whether the incidence or early mortality related to peptic ulcer perforation has changed. AIM: To evaluate the incidence and mortality related to peptic ulcer perforation while considering the intake of low-dose aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We recorded the numbers and details of all patients presenting in our region of Scotland with perforation between 1997 and 2006 including demography, drug usage and 30-day mortality. RESULTS: In subjects aged >65 years, the annual incidence of perforation was 32.7 per 10(5) of the age-specific population, of whom 10.7 per 10(5) were taking low-dose aspirin and 12.0 taking NSAIDs. These were all significantly higher (P < 0.001) than the corresponding incidence in subjects aged < or =65 years (6.6 per 10(5) overall, 1.1 taking aspirin and 2.5 taking NSAIDs). There was an increasing trend with time in the number of patients taking NSAIDs (chi(2) = 4.57, P = 0.03). Using univariate analysis, 30-day mortality was associated with aspirin [odds ratio, 2.32 (95% C.I., 1.20-4.47), P = 0.01] but not with NSAIDs. The strongest predictors of mortality were increasing age and comorbidity. CONCLUSIONS: Perforation remains common in elderly patients including users of NSAIDs and aspirin. Early mortality is also noted in association with increasing age and comorbidity, but not independently with drug intake.

Bariatric surgery improves cardiac function in morbidly obese patients with severe cardiomyopathy.

BACKGROUND: Longstanding morbid obesity can be associated with severe cardiomyopathy. However, the safety and efficacy of bariatric surgery in patients with severe cardiomyopathy has not been studied, and the effect of surgical weight loss on postoperative cardiac function is also unknown. In addition, morbidly obese patients have significantly increased mortality associated with cardiac transplantation, often precluding them from becoming recipients. METHODS: A retrospective study of patients with a left ventricular ejection fraction < or =35% who underwent bariatric surgery (1998-2005) was performed. Short-term morbidity/mortality, length of stay, excess weight loss, pre- and postoperative left ventricular ejection fraction, and New York Heart Association (NYHA) functional class were assessed. RESULTS: A total of 14 patients (10 men and 4 women) with a mean preoperative body mass index of 50.8 +/- 2.04 kg/m(2) underwent bariatric surgery (10 underwent laparoscopic Roux-en-Y gastric bypass, 1 open Roux-en-Y gastric bypass, 2 sleeve gastrectomy, and 1 laparoscopic gastric banding). The complications were pulmonary edema in 1, hypotension in 1, and transient renal insufficiency in 2. The median length of stay was 3.0 days (range 2-9). The mean excess weight loss at 6 months was 50.4%, with a decrease in the mean body mass index from 50.8 +/- 2.04 kg/m(2) to 36.8 +/- 1.72 kg/m(2). The mean left ventricular ejection fraction at 6 months had significantly improved from 23% +/- 2% to 32% +/- 4% (P = .04), correlating with improved functional capacity, as measured by the NYHA classification. Preoperatively, 2 patients (14%) had an NYHA classification of IV, 6 (43%) a classification of III, and 6 (43%) a classification of II. At 6 months postoperatively, no patient had an NYHA classification of IV, 2 (14%) had a classification of III, and 12 (86%) an NYHA classification of II. Two patients had undergone cardiac transplant evaluations preoperatively and underwent successful transplantation after weight loss. CONCLUSION: The results of our study have shown that bariatric surgery for patients with cardiomyopathy is feasible and effective. Surgically induced weight loss results in both subjective and objective improvement in cardiac function. In addition, surgical weight loss can provide a bridge to transplantation in patients who were prohibited secondary to their morbid obesity.

Upper gastrointestinal bleeding and the changing use of COX-2 non-steroidal anti-inflammatory drugs and low-dose aspirin.

BACKGROUND: Rofecoxib was withdrawn in 2004. AIM: To assess the incidence of upper gastrointestinal bleeding in the context of the changing use of cyclo-oxygenase-2 non-steroidal anti-inflammatory drugs and low-dose aspirin. METHODS: We examined the characteristics of patients developing upper gastrointestinal bleeding in a defined population in south-west Scotland. The primary comparisons were made between two calendar years, preceding and following the withdrawal of rofecoxib. RESULTS: The overall incidence of upper gastrointestinal bleeding rose from 98.7 in 2002 to 143 per 10(5) of the population per annum in 2005 (chi(2) = 21.1; P < 0.001). The rise in the incidence was associated with using low-dose aspirin, from 26.6 to 38.4 per 10(5) (chi(2) = 5.4; P = 0.02), other antithrombotic drugs, from 12.1 to 30.2 per 10(5) (chi(2) = 19.6; P < 0.001), and excess alcohol, from 23.5 to 36.4 per 10(5) (chi(2) = 7.1; P = 0.008), but insignificantly with using non-steroidal anti-inflammatory drugs, from 13.3 to 16.1 per 10(5) (chi(2) = 0.64; P = 0.4). After adjustment for the concomitant use of these drugs, there was no significant trend in the incidence of upper gastrointestinal bleeding associated with non-steroidal anti-inflammatory drugs over the period of 1996-2005. CONCLUSION: The rise in the incidence of upper gastrointestinal bleeding was weakly related to the change in use of non-steroidal anti-inflammatory drugs. Instead, it probably reflected the increasing use of low-dose aspirin, other antithrombotic drugs and alcohol.

Hypoxia renders hepatocytes susceptible to cell death by nitric oxide.

Under normoxic conditions, nitric oxide (NO) suppresses hepatocyte apoptosis. In contrast, NO contributes to hepatocellular injury in conditions associated with ischemia and reperfusion. To understand this paradoxical effect further, we compared the effects of various doses of NO, delivered from the chemical NO donor S-nitroso-N-acetylpenicillamine (SNAP), under both normoxic and hypoxic tissue culture conditions. We found that the cell death induced by NO under hypoxic conditions, which increased the production of reactive oxygen species, was accompanied by a necrotic morphology with a concomitant early decrease in ATP levels. The NO-induced death of hypoxic hepatocytes was reversed by co-incubation with the anti-oxidant N-acetylcysteine. We conclude that hypoxia-induced oxidative stress subsequent to ATP depletion can switch NO from an anti-apoptotic to a hepatotoxic agent. These findings may have implications for NO-induced liver damage in settings of tissue hypoxia.

The influence of protein adsorption and surface modifying macromolecules on the hydrolytic degradation of a poly(ether-urethane) by cholesterol esterase.

Previous investigations have demonstrated that the inflammatory cell derived enzyme, cholesterol esterase (CE) could degrade polyurethanes (PUs) by hydrolyzing ester and urethane bonds. Studies that have investigated the development of protective coatings for PUs have reported that the polymer degradation of polyester-urethanes (PESUs) can be reduced with the use of fluorine containing surface modifying macromolecules (SMMs). Since these latter studies were carried out in the presence of relatively pure enzyme, it has not been shown if SMMs would still provide an enhanced inhibitory effect if surfaces were pre-exposed to plasma proteins. This would be more representative of the in vivo scenario since protein adsorption would occur before the appearance of monocyte-derived macrophages which would be a primary source of esterase activities. The current investigation has focused on studying the influence of fibrinogen (Fg) as a simple model of protein adsorption in order to assess the effect of CE in combination with protein on polyether-urethane (PEU) surfaces. The materials were prepared with and without SMMs, and were pre-coated with Fg prior to carrying out biodegradation studies. The pre-adsorption of Fg onto the modified and non-modified surfaces provided a significant delay in the hydrolytic action of CE onto the PEU substrates. However, the effect was gone by 70 days and by the 126th day of incubation, both Fg coated and non-Fg coated groups had the same level of degradation. The difference between Fg coated and non-coated substrates was much smaller for materials containing SMMs. In addition, the pre-adsorption of Fg did not alter the SMMs' ability to provide a more biostable surface over the 4 month incubation period.

Fluorinated surface-modifying macromolecules: modulating adhesive protein and platelet interactions on a polyether-urethane.

Polyether-urethanes (PEUs) have been the materials of choice for the manufacture of conventional blood-contacting devices. Nevertheless, biostability and blood compatibility are still among the principal limitations in their long-term application. Studies investigating the development of protective coatings for PEUs have shown that degradation can be reduced with the use of fluorinated surface-modifying macromolecules (SMMs). It has also been hypothesized that SMM-modified PEU surfaces may exhibit improved blood compatibility because other studies have shown a modulation in fibrinogen adsorption onto these surfaces. To determine the blood compatibility of a PEU-containing fluorinated SMMs, a series of in vitro experiments were designed to study the pattern of protein adsorption from plasma and then to assess the nature of platelet adhesion and activation on each substrate. Western blot analysis as well as single protein studies revealed that the dominant "adhesive proteins" [fibrinogen (Fg), fibronectin (Fnc), and vitronectin (Vnc)] were adsorbed on two of the SMM-containing PEUs in lower amounts relative to unmodified base. Platelet adhesion and activation data further highlighted the differences among the various substrates. It was shown that the unmodified base had a higher number of adhered platelets relative to the SMM-modified surfaces, and that of the SMM-containing substrates, which showed the lowest levels of adhesive proteins also, exhibited significantly lower platelet densities. Close morphological examination further revealed that platelets residing on these latter substrates were not appreciably activated. Based on the current evidence, it is believed that the fluorinated SMMs demonstrate good potential for the development of surfaces with minimal thrombogenic character in in vivo applications.

The hepatocyte as a microbial product-responsive cell.

Much research has focused on the responses to microbial products of immune cells such as monocytes, macrophages, and neutrophils. Although the liver is a primary response organ in various infections, relatively little is known about the antimicrobial responses of its major cell type, the hepatocyte. It is now known that the recognition of bacteria occurs via cell-surface proteins that are members of the Toll-like receptor (TLR) family. In addition, lipopolysaccharide (LPS) is bound by circulating LPS-binding protein (LBP) and presented to cell-surface CD14, which in turn interacts with TLR and transduces an intracellular signal. We investigated the CD14 and TLR2 responses of whole liver and isolated hepatocytes, and demonstrated that these cells can be induced to express the molecules necessary for responses to both Gram-positive and Gram-negative bacteria. Our findings may have clinical implications for pathological states such as sepsis.

Adverse sedation events in pediatrics: analysis of medications used for sedation.

OBJECTIVES: To perform a systematic investigation of medications associated with adverse sedation events in pediatric patients using critical incident analysis of case reports. METHODS: One hundred eighteen case reports from the adverse drug reporting system of the Food and Drug Administration, the US Pharmacopoeia, and the results of a survey of pediatric specialists were used. Outcome measures were death, permanent neurologic injury, prolonged hospitalization without injury, and no harm. The overall results of the critical incident analysis are reported elsewhere. The current investigation specifically examined the relationship between outcome and medications: individual and classes of drugs, routes of administration, drug combinations and interactions, medication errors and overdoses, patterns of drug use, practitioners, and venues of sedation. RESULTS: Ninety-five incidents fulfilled study criteria and all 4 reviewers agreed on causation; 60 resulted in death or permanent neurologic injury. Review of adverse sedation events indicated that there was no relationship between outcome and drug class (opioids; benzodiazepines; barbiturates; sedatives; antihistamines; and local, intravenous, or inhalation anesthetics) or route of administration (oral, rectal, nasal, intramuscular, intravenous, local infiltration, and inhalation). Negative outcomes (death and permanent neurologic injury) were often associated with drug overdose (n = 28). Some drug overdoses were attributable to prescription/transcription errors, although none of 39 overdoses in 34 patients seemed to be a decimal point error. Negative outcomes were also associated with drug combinations and interactions. The use of 3 or more sedating medications compared with 1 or 2 medications was strongly associated with adverse outcomes (18/20 vs 7/70). Nitrous oxide in combination with any other class of sedating medication was frequently associated with adverse outcomes (9/10). Dental specialists had the greatest frequency of negative outcomes associated with the use of 3 or more sedating medications. Adverse events occurred despite drugs being administered within acceptable dosing limits. Negative outcomes were also associated with drugs administered by nonmedically trained personnel and drugs administered at home. Some injuries occurred on the way to a facility after administration of sedatives at home; some took place in automobiles or at home after discharge from medical supervision. Deaths and injuries after discharge from medical supervision were associated with the use of medications with long half-lives (chloral hydrate, pentobarbital, promazine, promethazine, and chlorpromazine). CONCLUSIONS: Adverse sedation events were frequently associated with drug overdoses and drug interactions, particularly when 3 or more drugs were used. Adverse outcome was associated with all routes of drug administration and all classes of medication, even those (such as chloral hydrate) thought to have minimal effect on respiration. Patients receiving medications with long plasma half-lives may benefit from a prolonged period of postsedation observation. Adverse events occurred when sedative medications were administered outside the safety net of medical supervision. Uniform monitoring and training standards should be instituted regardless of the subspecialty or venue of practice. Standards of care, scope of practice, resource management, and reimbursement for sedation should be based on the depth of sedation achieved (ie, the degree of vigilance and resuscitation skills required) rather than on the drug class, route of drug administration, practitioner, or venue.

Adverse sedation events in pediatrics: a critical incident analysis of contributing factors.

OBJECTIVE: Factors that contribute to adverse sedation events in children undergoing procedures were examined using the technique of critical incident analysis. METHODOLOGY: We developed a database that consists of descriptions of adverse sedation events derived from the Food and Drug Administration's adverse drug event reporting system, from the US Pharmacopeia, and from a survey of pediatric specialists. One hundred eighteen reports were reviewed for factors that may have contributed to the adverse sedation event. The outcome, ranging in severity from death to no harm, was noted. Individual reports were first examined separately by 4 physicians trained in pediatric anesthesiology, pediatric critical care medicine, or pediatric emergency medicine. Only reports for which all 4 reviewers agreed on the contributing factors and outcome were included in the final analysis. RESULTS: Of the 95 incidents with consensus agreement on the contributing factors, 51 resulted in death, 9 in permanent neurologic injury, 21 in prolonged hospitalization without injury, and in 14 there was no harm. Patients receiving sedation in nonhospital-based settings compared with hospital-based settings were older and healthier. The venue of sedation was not associated with the incidence of presenting respiratory events (eg, desaturation, apnea, laryngospasm, approximately 80% in each venue) but more cardiac arrests occurred as the second (53.6% vs 14%) and third events (25% vs 7%) in nonhospital-based facilities. Inadequate resuscitation was rated as being a determinant of adverse outcome more frequently in nonhospital-based events (57.1% vs 2.3%). Death and permanent neurologic injury occurred more frequently in nonhospital-based facilities (92.8% vs 37.2%). Successful outcome (prolonged hospitalization without injury or no harm) was associated with the use of pulse oximetry compared with a lack of any documented monitoring that was associated with unsuccessful outcome (death or permanent neurologic injury). In addition, pulse oximetry monitoring of patients sedated in hospitals was uniformly associated with successful outcomes whereas in the nonhospital-based venue, 4 out of 5 suffered adverse outcomes. Adverse outcomes despite the benefit of an early warning regarding oxygenation likely reflect lack of skill in assessment and in the use of appropriate interventions, ie, a failure to rescue the patient. CONCLUSIONS: This study-a critical incident analysis-identifies several features associated with adverse sedation events and poor outcome. There were differences in outcomes for venue: adverse outcomes (permanent neurologic injury or death) occurred more frequently in a nonhospital-based facility, whereas successful outcomes (prolonged hospitalization or no harm) occurred more frequently in a hospital-based setting. Inadequate resuscitation was more often associated with a nonhospital-based setting. Inadequate and inconsistent physiologic monitoring (particularly failure to use or respond appropriately to pulse oximetry) was another major factor contributing to poor outcome in all venues. Other issues rated by the reviewers were: inadequate presedation medical evaluation, lack of an independent observer, medication errors, and inadequate recovery procedures. Uniform, specialty-independent guidelines for monitoring children during and after sedation are essential. Age and size-appropriate equipment and medications for resuscitation should be immediately available regardless of the location where the child is sedated. All health care providers who sedate children, regardless of practice venue, should have advanced airway assessment and management training and be skilled in the resuscitation of infants and children so that they can successfully rescue their patient should an adverse sedation event occur.

Rotavirus shedding in feces of gnotobiotic calves orally inoculated with a commercial rotavirus-coronavirus vaccine.

The purpose of this study was to monitor by negative stain electron microscopy the shedding of rotavirus in the feces of gnotobiotic calves orally inoculated with a commercial modified live bovine rotavirus-bovine coronavirus vaccine. Negative stain electron microscopic examination detected vaccine rotavirus in only 1 of 41 daily fecal specimens collected from 3 gnotobiotic calves during the 2 weeks following oral inoculation with a US Department of Agriculture-licensed modified live bovine rotavirus-bovine coronavirus vaccine. In contrast, rotavirus was demonstrable by the same negative stain electron microscopic examination procedure in 17 of 19 fecal specimens collected from diarrheic gnotobiotic or colostrum-deprived calves during the first 8 days after inoculation with virulent bovine rotavirus field strains. Rotavirus was also detected by this procedure in 4 enzyme-linked immunosorbent assay positive fecal specimens collected from naturally-infected diarrheic dairy calves. These results suggest that fecal shedding of vaccine rotavirus demonstrable by electron microscopic examination is uncommon following oral inoculation of calves with the bovine rotavirus-bovine coronavirus vaccine.

Expression of a 130-kDa mesothelial and ciliated cell Ag (MCp130) in normal and developing human and rat lung and its role as a diagnostic marker for mesotheliomas and tumors of the female reproductive system.

BACKGROUND: Proteins in human lung lavage were analyzed to identify cell-specific markers for potential use in the study of the biology and pathology of pulmonary cells. EXPERIMENTAL DESIGN: Proteins associated with pulmonary surfactant were used to raise mAb. An Ab to a 130-kDa protein (MCp130) was reactive with ciliated and mesothelial cells. Expression of this Ag in normal organs, developing lung, and tumors was investigated. RESULTS: By Western blotting, the Ab stained a protein of about 130 kDa. In formalin-fixed, paraffin-embedded tissues from adult human and rat organs, the Ab specifically stained the luminal/apical surfaces of pulmonary and nonpulmonary ciliated and mesothelial cells. Staining of fetal airway cells was independent of ciliation. Airway cell staining was detectable in human fetal lungs at 12 weeks of gestation and at Day 18 of gestation in fetal rat. The Ab reacted with human and rat fetal mesothelial cells at the gestational ages of 15 weeks and 17 days, respectively. It also stained ciliated cells in endosalpinx and endometrium. Human epithelial mesotheliomas and ovarian and endometrial carcinomas stained selectively, whereas other pulmonary tumors and tumors of other organs did not react with the Ab. CONCLUSIONS: This 130-kDa mesothelial and ciliated cell plasma membrane protein appears in developing lung at an earlier age than secretory proteins. The marker is of potential use in the study of development of the different cell lineages in the lung and female reproductive tract. The Ab is expected to be useful in the diagnosis of epithelial mesotheliomas and ovarian/endometrial carcinomas, because it selectively stains these tumors and is reactive with formalin-fixed, paraffin-embedded tissues.

Temafloxacin syndrome: review of 95 cases.

Four months after its approval in the United States, temafloxacin was withdrawn from the market worldwide because of frequent reports of serious hemolysis with or without other organ system dysfunction. We describe this "temafloxacin syndrome" on the basis of a review of 95 spontaneous reports of hemolysis sent to the Food and Drug Administration. Patients typically presented with fever, chills, and jaundice a mean of 6.4 days after starting therapy. A moderate degree of hemolysis was reflected by the mean drop in hemoglobin level (by 42 g/L) and by the mean lowest concentration of hemoglobin (97 g/L). New-onset renal dysfunction was noted in 54 cases (57%), and dialysis was required in 34 cases (63%). Coagulopathy was noted in 33 cases (35%), and 48 cases (51%) met the criteria for hepatic dysfunction. Four patients developed central nervous system complications, and two patients died. Prior quinolone use was more common among patients who developed hemolysis after only one dose as opposed to two or more doses (P < .001). These data suggest that temafloxacin causes immune hemolytic anemia, most likely secondary to immune complex formation.