Cataract surgery is one of the most frequent surgeries in the world. It is a very safe procedure mostly performed under topical anesthesia in outpatients centers. Due to the growing lack of ...anesthesiologists, cataract surgeries are more frequently performed without an anesthesiologist present in the operating room. Although extremely rare, life-threatening complications may occur.
We report two cases of cataract surgery complicated by severe hypotension that required emergency resuscitation in the immediate postoperative period and hospitalization in intensive care unit. Anaphylactic shock was confirmed in the first case and suspected in the second.
Even though cataract surgery is a very safe procedure, it is essential to ensure the presence of an anesthesiologist to manage potential, though extremely rare, life-threatening complications such as anaphylactic reactions.
The consistent association between choroid neovascularization (CNV) and increased VEGF-A expression provides a strong reason for exploring the therapeutic potential of anti-VEGF agents in the ...treatment of neovascular age-related macular degeneration (AMD). The authors report the systemic side effects secondary to intravitreal administration of these compounds, that is, the main cardiovascular effects, as well as the less frequent cerebrovascular accidents, myocardial infarction, transient ischemic attacks, deep vein thrombosis, pulmonary embolism and thromboflebitis.
The authors reviewed major Clinical Trials and publications concerning systemic adverse events of anti-VEGF drugs in order to identify the main thromboembolic events related to the use of these agents and their occurrence. Anti-VEGF efficacy, safety and tolerability are also discussed.
Three compounds (pegaptanib, ranibizumab and aflibercept) have been approved for the treatment of AMD; a fourth agent, bevacizumab, is used off-label. Anti-VEGF therapy has not shown the ability to fully eradicate the CNV, so that recurrences are common when the intravitreal injections are suspended. Although no evident rise in anti-VEGF-induced thromboembolic side effects was reported, more data are required to evaluate hemodynamic and pharmacokinetics of these compounds. Since only few studies have focused on these aspects, further researches are mandatory to determine distribution, effects and duration of these substances.
To determine whether preoperative medical testing reduces the risk of postoperative systemic adverse events after vitreoretinal surgery.
Retrospective cohort study at a single academic university ...hospital involving a total of 2,215 patients undergoing vitreoretinal surgery. Medical charts of 2,215 patients who underwent vitreoretinal surgery between January 2002 and November 2011 at Vanderbilt University were reviewed for baseline comorbidities, preoperative testing, type of anesthesia during surgery, and systemic adverse events occurring within 30 days after surgery. Main outcome measures were the association of baseline characteristics and preoperative testing with postoperative systemic adverse events.
Approximately a half of patients had electrolyte, renal function, and electrocardiogram evaluation. The most common comorbidities were hypertension (53%), diabetes mellitus (37%), and coronary artery disease (18%). The most common preoperative testing performed was blood glucose (58%). A total of 102 systemic adverse events occurred in 89 of 2,215 patients (4%) within the first 30 days after surgery with the majority (72%) occurring within the first 24 hours. The most common adverse event was bradycardia (34%) followed by desaturation (25%). Patients with a history of coronary artery disease, asthma, chronic renal disease, or receiving general anesthesia had a 2.04 (P = 0.01), 2.18 (P = 0.03), 2.76 (P < 0.01), and 3.72 (P < 0.001) increased odds of developing postoperative systemic adverse events, respectively. Multivariate logistic regression analysis demonstrated no significant correlation between preoperative testing and postoperative adverse events.
Incidence of postoperative systemic adverse events after vitreoretinal surgery was 4% and was significantly increased in patients with coronary artery disease, asthma, chronic renal disease, or receiving general anesthesia. In this series, preoperative testing did not measurably influence rates of postoperative systemic complications.
Purpose: Two new Staphylococcus aureus vaccines, S. aureus four-antigen (SA4Ag) and three-antigen (SA3Ag) vaccines, have good immunogenicity and tolerance. However, the safety of these vaccines is ...worth exploring. Here, we performed a meta-analysis to investigate the safety of SA3Ag and SA4Ag by evaluating systemic and local adverse events.
Methods: The Medline, EMBASE, and Cochrane databases were searched for randomized clinical trials confirming the safety of SA4Ag and SA3Ag. Two investigators independently selected suitable trials, assessed trial quality, and extracted data.
Results: Three studies comprising a total of 1,148 participants were included in this review. The two S. aureus vaccines did not increase systemic adverse events (relative ratio 1.1 95% confidence interval 0.98, 1.24), but increased the incidence of local adverse events (2.89 2.15, 3.90). However, the incidence of severe local adverse events (4.06 0.78, 21.24) did not rise significantly.
Conclusions: SA4Ag and SA3Ag have acceptable safety in adults.
Glucocorticosteroids and aminosalicylates, mainly mesalazine (5-ASA), are both standard therapeutics in the treatment of inflammatory bowel disease (IBD) patients. The glucocorticosteroids are highly ...effective in inducing remission in both ulcerative colitis and Crohn's disease, but their use is limited by the high incidence and the potentially serious nature of adverse events. In an attempt to limit systemic side effects, rapidly metabolized corticosteroids such as budesonide have been introduced. The safety profile of aminosalicylates differs between the formulations.
We summarize the potential risks associated with glucocorticosteroid and aminosalicylate therapy in IBDs.
The numerous adverse events of glucocorticosteroids, particularly at high doses and prolonged treatment, include opportunistic infections, diabetes mellitus, hypertension, ocular effects (glaucoma and cataracts), psychiatric complications, hypothalamic-pituitary-adrenal axis suppression and increased fracture risk. Partially, these systemic adverse events occur with budesonide, which only has a low systemic exposure. The safety profile of 5-ASA is comparable to placebo and superior to the old aminosalicylate prodrug sulfasalazine, which had a significantly higher incidence of intolerance reactions including allergic rashes. Only in rare cases has nephrotoxicity such as interstitial nephritis been associated with 5-ASA.
Considering the toxicity profile of conventional glucocorticosteroids, one primary goal of treatment in IBD should be corticosteroid-free remission. Therapy with budesonide may result in a better safety profile. 5-ASA treatment is usually well tolerated, but with regard to the rare nephrotoxic events, it is advisable to assess renal function before and during treatment with 5-ASA.
To determine rates of intraoperative and postoperative systemic and ocular adverse events and establish the value of preoperative medical assessment in patients undergoing surgery for primary ...rhegmatogenous retinal detachment repair at a single academic center.
Retrospective cohort study of 185 patients undergoing surgery for repair of primary rhegmatogenous retinal detachment (RRD) at a single academic center. Medical records were reviewed for medical comorbidities, completion of preoperative medical examination, anesthesia used during surgery, intraoperative adverse medical events, intraoperative ocular complications, and systemic and ocular postoperative complications. The main outcome of interest was the association of comorbidities and preoperative medical evaluation with intraoperative and postoperative complications.
Approximately 48% of the patients presented with no medical comorbidities of interest. Formal preoperative evaluation by an independent medical provider was completed in 36% of the patients. Overall, intraoperative and postoperative systemic complications (5.7% and 1%, respectively) and intraoperative and postoperative ocular complications (0.5% for both) were uncommon. Patients with a history of chronic heart failure (OR 24.5,
=0.02) or who received general anesthesia (OR 9.56,
<0.001) had increased risk of having experienced any intraoperative or postoperative complication. No relationship between preoperative medical evaluation and intraoperative and postoperative complications was observed.
Patients undergoing surgery for RRD repair presented with fewer medical comorbidities than previously reported in patients undergoing all vitreoretinal surgeries. Intraoperative and postoperative complications were uncommon and were increased in patients with chronic heart failure or who received general anesthesia. Complications were not significantly associated with preoperative evaluation by an independent medical provider.
Abstract Objective To determine the cardiovascular events in naïve patients with diabetic macular oedema, before and after being treated with intravitreal ranibizumab. Material and methods A ...retrospective and descriptive study was conducted on patients with diabetic macular oedema and foveal involvement, who started treatment with intravitreal ranibizumab in 2014 in the Hospital Universitario Nuestra Señora de Candelaria and the Hospital Universitario y Politécnico La Fe. During the follow-up until August 2015, a record was made of parameters, including the prevalence and incidence of stroke and myocardial infarction. Results Among the 1324 intravitreal ranibizumab injections administered in 2014, only 159 of them corresponded to treatment initiation in 99 patients, with more than half requiring treatment of both eyes. The study patients included 58.4% males, in the 6th decade of life (mean = 65.93 ± 11.24 years), non-smokers (86.7%), type 2 diabetes (91.9%), hypertension (70.7%), and with dyslipidaemia (65.7%). Prior to treatment initiation, it was found that 6 patients (6.1%) suffered from an acute myocardial infarction, and 8 (8.1%) from stroke, and only one (1%) with post-stroke ( p = 0.039). Conclusion In our experience it seems that the intravitreal ranibizumab in diabetic macular oedema could be a safe alternative in patients with a history of stroke and myocardial infarction.
Abstract Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO® is a Vero cell-derived, inactivated JE virus vaccine which has recently been approved in the US, Europe, ...Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO® , for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO® vaccination, 435 subjects with a JE-VAX® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH)3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO® ; 40% PBS + Alum vaccination). JE-VAX® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX® (64%); as for subjects with serious AEs (1% IXIARO® ; 2% PBS + Alum vaccination, 1% JE-VAX® ). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX®.
Bacillus anthracis is the major terrorist and biological warfare agent of concern to civilian and military medical planners. The licensed anthrax vaccine, adsorbed (AVA) is believed to be an ...effective prophylactic medical countermeasure against this threat. Our objective in this report was to expand the safety database for this vaccine by assessing data on self-reported, short-term safety of AVA during more than 25 years of use, measured by local and systemic adverse events temporally associated with the administration of AVA. A minority of AVA recipients reported systemic and injection site reactions. Females reported a higher incidence of injection site and systemic adverse events than males. Data show a difference in incidence of local reactions between lots. A prospective, randomized, placebo-controlled study to actively examine reactogenicity is needed to more completely define the extent and nature of reactions associated with receipt of AVA in humans as well as to confirm the gender lot differences in local reaction rates.
Inhaled corticosteroids (ICSs) are considered the most effective therapy currently available for persistent asthma and is the guideline-recommended first-line treatment for all patients requiring ...controller medication; however, the potential for oropharyngeal and systemic adverse events can be a barrier to their use. Ciclesonide (CIC) is a new ICS with a unique pharmacologic profile that may confer a favorable safety profile. This study was designed to provide a comprehensive review of currently available safety data for CIC in adults and children with asthma of all severities. The literature was reviewed for all clinical trials with CIC reporting safety results (no date restrictions; English language only). Clinical trials with CIC in children and adults showed a very low occurrence of oropharyngeal adverse events (including oral candidiasis, pharyngitis, and hoarseness) and minimal systemic activity. In particular, no clinically relevant effect on cortisol levels was observed, compared with placebo or active comparators, even with high-dose CIC treatment (up to 1280 microg/day) and in asthma of all severities. Furthermore, there was no clinically relevant effect of CIC treatment on growth in children with mild asthma compared with placebo. The favorable safety profile of CIC may allay patient and physician concern regarding ICS when using this agent. Guideline-recommended use of ICS medications may help optimize treatment outcomes in asthma.
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