Delayed adverse reactions in whole blood donors: Importance of active surveillance in identifying the missing gaps in the donor safety.

Background & objectives: The information available regarding delayed adverse donor reactions (D-ADRs) is limited. Proactive follow up of donors for delayed reactions is not done routinely. This study was undertaken to analyze frequency and type of D-ADRs in whole blood donors as also the contributory factors. Methods: In this prospective observational study, all eligible whole blood donors were contacted telephonically twice (24 h and 2 wks after donation) and asked about general health and ADR specific questions. The International Society of Blood Transfusion standard guidelines were used to categorize ADRs. Results: The ADR data of 3514 donors were analyzed in the study. D-ADRs were more common as compared to immediate delayed adverse donor reactions (I-ADRs) (13.7 vs. 2.9%, P<0.001). The most common D-ADRs were bruises (4.98%), fatigue or generalized weakness (4.24%) and sore arms (2.25%). D-ADRs were more common in first time donors as compared to the repeat blood donors (16.1 vs. 12.5%, P=0.002). Females were more prone to D-ADRs (17 vs. 13.6%). Localized D-ADRs were more frequent as compared to systemic D-ADRs (P<0.001). Repeat donors had a lower incidence of systemic D-ADRs (4.11% vs. 7.37%, P<0.001). Interpretation & conclusions: D-ADRs were more common than I-ADRs with a different profile. First time, female and young donors were more prone to D-ADRs. These categories need special care at the time of blood donation. Active follow up of blood donors should be done from time to time to strengthen donor safety.

Hypersensitivity reactions to iodinate contrast media in Italy: a retrospective study. Characteristics of patients and risk factors.

SUMMARY: Objective. The purpose of the study was to describe the characteristics of patients experiencing hypersensitivity reactions (HRs) to iodinated contrast media (ICM) in a large Italian population and to investigate potential risks factors in order to obtain a risk stratification, helpful in the management of these patients. Methods. Data of 407 patients investigated in 9 Italian Allergy Centers for suspected HRs to ICM were analyzed and compared with a control group of 152 subjects that tolerated one or more ICM-enhanced examinations. The univariate and multivariate logistic regression model was used to evaluate associated factors. Results. The mean age of reactive patients was 61 years and 60% were female; 67% of patients reported immediate reactions and 35% experienced the reaction, more frequently with immediate onset, at the first examination in life. Iomeprol, iopromide and iodixanol were the most frequent culprit agents and 20% of patients showed a positive skin test result. Previous adverse reactions to ICM were reported by 15.6% of patients, whereas 35% of subjects experienced the reaction, more frequently immediate, after the first ICM-enhanced examination in their life. The multivariate analysis showed that male gender and age > 65 were associated with ICM reactions as protective factors [ORadja = 0.51; 95% CI: 0.33-0.77 and ORadja = 0.60; 95% CI: 0.39-0.92 respectively]. Cardio-vascular disease [ORadja = 2.06; 95% CI: 1.22-3.50)], respiratory allergy [ORadja = 2.30; 95% CI: 1.09-4.83)] and adverse drug reactions [ORadja = 1.99; 95% CI: 1.05-3.77)] were identified as risk factors for ICM reactions. Food allergy was not significantly associated with reactions [ORadja = 1.51; 5% CI: 0.41-5.56]. Conclusions. This is the largest study on Italian patients experiencing hypersensitivity reactions to ICM. Most results are in line with other studies, showing some association with factors that could influence the incidence of hypersensitivity reactions but not allowing an easy risk stratification.

Delayed symptoms and orthostatic intolerance following peanut challenge.

BACKGROUND: Clinical reactions to Oral Food Challenge (OFC) in peanut-allergic individuals have been well-characterised, but rates and phenotypes of symptom recurrence beyond the first hour after objective symptoms are less well-characterised. OBJECTIVE: To evaluate the rate of new-onset symptoms occurring at least 1 h after stopping OFC in peanut-allergic children and adults undergoing peanut-OFC. METHODS: We prospectively collected data relating to adverse events following positive reactions at double-blind, placebo-controlled food challenges (DBPCFC) to peanut in children and adults evaluated for eligibility to participate in two clinical trials (NCT02149719, NCT02665793). The trials included people aged 8 to 45 with primary, IgE-mediated peanut allergy at DBPCFC. The challenge protocol included consumption of a light meal 1 h after reaction. RESULTS: A total of 121 participants (64 children, 57 adults) had immediate, objective symptoms at DBPCFC, 25 (17 children, 8 adults) with anaphylaxis. Thirty-three (27%) had progression or recurrence of symptoms ≥ 1 h after objective clinical reaction, of whom 8 developed anaphylaxis. In 23 cases, the onset of new symptoms was associated with consumption of a light meal. In eight cases, symptoms were limited to a symptomatic postural fall in blood pressure noted in preparation for discharge, without any other new features of an allergic reaction. CONCLUSIONS & CLINICAL RELEVANCE: Progressive or new-onset symptoms ≥1 h following initial allergic reaction at OFC are common and can include orthostatic hypotension. Recurrent symptoms may be temporally associated with food consumption.

Cutaneous drug reactions to antiepileptic drugs and relation with HLA alleles in the Turkish population.

Summary: Background and objective. Many studies have shown associations between HLAB*15:02, HLA-A*31:01 and carbamazepine (CBZ)-induced delayed cutaneous hypersensitivity reactions. The aim of this study is to evaluate a possible association between delayed cutaneous reactions to antiepileptic drugs (AEDs) and certain HLA-A and HLA-B alleles in the Turkish population. Methods. The study consisted of 3 groups: Group I (reactive group) included the patients who had documented delayed cutaneous reactions to any antiepileptic drug. Group II (non-reactive group) included the patients who have been on antiepileptic treatment at least for three months without any adverse reactions. Group III consisted of healthy subjects. The HLA-A and B alleles were analyzed in all groups. Results. Forty patients (29 female) had experienced different hypersensitivity reactions due to AEDs: maculopapular exanthema (26 patients), Stevens-Johnson syndrome (6 patients), drug rash with eosinophilia and systemic symptoms (7 patients), toxic epidermal necrolysis (1 patient). Lamotrigine (11) and CBZ (10) were the most common culprit drugs involved in the reactions. The HLA-B*15:02 was not present in any of the study groups. However, HLA-B*35:02 was found in 4 patients from the reactive group, while it was not observed in non-reactive patients and was detected in only one healthy subject (p = 0.021). Conclusion. Although our preliminary results did not indicate a strong allele association with AED hypersensitivity, HLA-B*35:02 appears to be a candidate allele for MPE / DRESS / DIHSS induced by AED's in Turkish population. Further studies with a larger sample size may result in more comprehensive data about the genetic tendency for AED hypersensitivity in the Turkish population.

Consensus document on the approach to children with allergic reactions after vaccination or allergy to vaccine components.

Vaccinations are one of the main public health tools for the control of vaccine-preventable diseases. If a child is identified as having had an allergic reaction to a vaccine, subsequent immunisations will probably be suspended - with the risks such a decision implies. The incidence of severe allergic reactions is very low, ranging between 0.5 and 1 cases/100,000 doses. Rather than the vaccine antigens as such, the causes of allergic reactions to vaccines are often residual protein components of the manufacturing process such as gelatine or egg, and less commonly yeasts or latex. Most vaccine reactions are mild and circumscribed to the injection site; although in some cases severe anaphylactic reactions can be observed. If an immediate-type allergic reaction is suspected at vaccination, or if a child with allergy to some of the vaccine components is scheduled for vaccination, a correct diagnosis of the possible allergic process must be made. The usual vaccine components must be known in order to determine whether vaccination can be safely performed.

Provocation Tests in Nonimmediate Hypersensitivity Reactions to ß-Lactam Antibiotics in Children: Are Extended Challenges Needed?

BACKGROUND: ß-Lactam antibiotics are the most common trigger of reactions in children with most of them being nonimmediate (85.5%), but proven allergy after the allergological workup is between 7% and 10%. There is no agreement on how to perform the provocation tests in these types of hypersensitivity reactions. OBJECTIVE: To determine whether or not repeated doses of the ß-lactams are required to reproduce a nonimmediate reaction in children. METHODS: This is a retrospective observational study. We included children under 14 years who were referred for a nonimmediate reaction to ß-lactams. All patients underwent a 1-day hospital provocation and were kept under observation at home during the following days for at least the time elapsed between the first dose and the symptoms of the index reaction. If no reaction was triggered, the patient resumed the provocation at home with 2 daily therapeutic doses for an equal of interval time. RESULTS: Ninety-seven patients were included in the study. A positive reaction was recorded in 14 of them (14.4%). The short hospital provocation triggered 3 immediate reactions and 8 delayed reactions. The home rechallenge developed 1 immediate reaction and 2 delayed reactions. CONCLUSIONS: Nonimmediate reactions to ß-lactams in children may be triggered with a 1-day provocation test. We suggest to perform a 1-day provocation test followed by an observational period of at least the time interval of the index reaction. If this challenge is negative, an extended home provocation could subsequently be carried out.

[Consensus position document on the child with an allergic reaction after vaccination or an allergy to vaccine components]. / Documento de consenso sobre la actitud ante un niño con una reacción alérgica tras la vacunación o alergia a componentes vacunales.

Vaccinations are one of the main public health tools for the control of vaccine-preventable diseases. If a child is labeled to have had an allergic reaction to a vaccine, the next immunizations will probably be suspended in that child, with the risks involved in this decision. The rate of severe allergic reactions is very low, ranging between 0.5-1/100,000 doses. The causes of allergic reactions to vaccines, more than the vaccine itself, are often due to residual protein components in the manufacturing process, such as gelatin or egg, and rarely to yeast or latex. Most of vaccine reactions are mild, localized at the site of injection, but in some circumstances, severe anaphylactic reactions can occur. If an immediate-type allergic reaction is suspected when vaccinating, or a child allergic to some of the vaccine components has to be vaccinated, a correct diagnosis of the possible allergy has to be made. The usual components of each vaccine should be known, in order to determine if vaccination can be performed safely on the child.

Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: a prospective multicenter cohort study.

BACKGROUND AND AIM: In patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. A retrospective study with small sample size demonstrated the feasibility of 1-hour infusion time for 10mg/kg infliximab in IBD patients. METHODS: Between November 2011 and July 2012, 63 patients received 1-hour 10mg/kg infliximab infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients. RESULTS: Sixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10mg/kg infusions during the study period. A total of 182 infliximab infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred. CONCLUSIONS: In patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab infusions in this patient population.

Iodixanol-Induced Fixed Drug Eruption Diagnosed by Systemic Provocation Test / 대한피부과학회지

Most cases of delayed skin reactions attributed to non-ionic iodinated contrast media, reported to date, have been maculopapular rash, which frequently occurs on the trunk and proximal region of the extremities. Only few cases of fixed drug eruption caused by non-ionic iodinated contrast media have been reported. A 48-year-old man developed multiple sharply marginated, hyperpigmented, oval patches on the trunk and extremities after receiving iodixanol (Visipaque(R), GE healthcare, USA). The patch test was carried out with a panel of the available iodinated non-ionic contrast media, but did not induce a positive reaction to any of the tested contrast media. The provocation test was carried out with iodixanol as 1/10 of the amount administered during the procedure that caused the reaction. On the following morning, the lesions increased in size and number. We report a case of iodixanol-induced fixed drug eruption, diagnosed by a systemic provocation test.