Comparative Assessment of Platinum Salts and Taxane Group Hypersensitivity Reactions, The Role of Skin Tests in Diagnosis?

Purpose We aimed to investigate the role of skin tests (ST) in the diagnosis of hypersensitivity reactions (HSRs) with platinum salts (PS) and taxane (TX) groups drugs and their reliability in patient management. Materials and Method Patients' data who developed immediate HSR with PS and TX were recorded and ST was performed. The gradual challenge was applied to all patients with ST negative and grade 1–2 with the suspect drug. Results In total, the data of 104 patients (74 with PS, 30 with TX) who developed HSR against PS and TX were shared. The gradual challenge was applied to 72 ST negative and grade 1–2 patients (46 PS group, 26 TX group). The gradual challenge was negative in 39 patients in the PS group and 23 patients in the Tx group. The negative predictive value (NPV) for PS was 83% and NPV for TX was 88%. We found significantly higher skin test positivity in patients with PS and TX and grade 3 HSR ( p = 0.007, p = 0.001). A significant correlation was found between skin test positivity and early onset of symptoms ( p = 0.001 for PS, p = 0.015 for TX). In terms of symptoms witnessed in HSR, we observed the itching, urticaria, hypotension, syncope, and abdominal pain symptoms significantly more in the group with a positive skin test ( p < 0.024, p < 0.001, p < 0.001, p < 0.002, and p < 0.025, respectively). Conclusions We found very high NPV values for PS and TX. We found that the gradual challenge applied to patients with negative skin tests is reliable if Grade 3 HSR is not observed and with this approach, unnecessary desensitization processes and/or drug alterations can be avoided.

Hepatotoxicity-Related Adverse Effects of Proton Pump Inhibitors: A Cross-Sectional Study of Signal Mining and Analysis of the FDA Adverse Event Report System Database

Background and Objectives: Mounting evidence demonstrates that proton pump inhibitors (PPIs) are associated with a number of adverse effects. However, the literatures about hepatotoxicity-related adverse effects (HRAEs) of PPIs are mostly case reports and a few clinical studies.Methods: We evaluated the association between PPIs and HAREs using the reporting odd ratio (ROR) for mining the adverse event report signals in the FDA Adverse Event Reporting System (FAERS) database.Results: There were 23,825 reports of PPIs as primary suspect drug or second suspect drug, of which 3,253 reports were HRAEs. The top five HRAE signals caused by PPIs were hepatitis cholestatic, cholestasis, fulminant hepatitis, subacute hepatic failure, and acute hepatitis. We also summarized the signals of the HRAEs caused by each PPI. The simultaneous signals were cholestasis and hepatitis cholestatic. For the cholestasis signal, esomeprazole showed an ROR of 21.556 (95% CI 17.592–26.413); pantoprazole showed the highest ROR of 22.611 (95% CI 17.794–28.733) in the hepatic cholestatic signal; lansoprazole was the only PPI with expression in the coma hepatic signal, with an ROR of 10.424 (95% CI 3.340–32.532). By analyzing the reports of pantoprazole-induced hepatic encephalopathy, we found that patients aged over 65 years and males reported the highest rate. And from the combination of drugs and indications of drugs, no significant results were obtained.Conclusions: The RORs of signals of “cholestasis” were generally higher than those of “hepatocellular injury.” And the signals about “cholestasis” in HRAE caused by PPIs are more reported.

Adverse outcomes associated with the treatment of Toxoplasma infections

Adverse outcomes associated with the treatment of Toxoplasma gondii infections in patients with various health backgrounds have not been characterized. The aim of this study was to identify the adverse outcomes and adverse events associated with the current clinical treatments of Toxoplama gondii infections using real world data reported to the FDA adverse event reporting system (FAERS). Data submitted to FAERS between 2013 and 2019 was retrieved and analyzed. Reporting odds ratio of death was calculated for the drugs having ≥ 25 reports of adverse outcomes. The adverse event profiles for the same drugs were analyzed and the reporting odds ratio was calculated relative to all other drugs used in the treatment of Toxoplasma infections. There were 503 cases reporting the treatment of Toxoplasma infections in the FAERS database. Death (DE) was the adverse outcome in 102 reports, of which 23 (22.5%) anti-Toxoplasma drugs were listed as the primary suspect drug (PS). Clindamycin (2.04; 1.07–3.90) followed by pyrimethamine (1.53; 0.99–2.36) were the most likely to be associated with death. Adverse events analysis suggest that sulfonamides formulations may have a less favorable safety profile. Our study represents the first real-world analysis of adverse outcomes and events associated with the treatment of Toxoplasma infections. Our findings support the need to better understand the current first-line agents for Toxoplasma infections, in addition to underscoring the need to identify safer regimens.

Suspect drug interaction in gimmers

Suspect serious adverse event associated with vaccination in gimmersMultiple congenital defects in a stillborn calfSuspected alpha mannosidosis in a bovine fetusClostridial myocarditis in a two-week-old lambOtitis media in pigsThese are among matters discussed in the disease surveillance report for May 2017 from SAC Consulting: Veterinary Services (SAC C VS)

Evaluation of anaphylactic reaction as an adverse event for perindopril erbumine tablets

Perindopril erbumine is a tert-butylamine salt of perindopril used in the treatment of stable coronary artery disease and hypertension. The present study was aimed to evaluate the anaphylactic reaction as an adverse event for perindopril erbumine tablets. Electronic extraction of data from the safety database for this report includes all cases of anaphylactic reaction where perindopril was a primary or co-suspect drug. The study result have shown that there were overall 205 case reports for perindopril in the database, of which 200 cases were assessed as (potentially) perindopril and 05 were assessed as non-perindopril product. From the 200 case reports, 141 were serious and 59 were non-serious. Out of the 141 serious cases, 137 cases were medically confirmed while remaining 04 cases were consumer reports. Of the total 205 case reports there were five cases wherein the patient experienced anaphylactic reaction. The study concludes that three out of five cases entered in the drug safety database suggestive of a possible association between perindopril and anaphylactic reaction.DOI: http://dx.doi.org/10.3329/icpj.v3i4.18265 International Current Pharmaceutical Journal, March 2014, 3(4): 254-258

Can Intranasal Corticosteroids Cause Migraine-Like Headache?

Intranasal corticosteroids (INCs) act predominantly locally and are considered to exert minimal systemic effects. On reviewing the international data collected in the World Health Organization's global pharmacovigilance programme an unexpected cluster was found of 38 case reports of migraine in suspected connection with INCs. These reports came from five countries (May 2007) and concerned six different drugs. In all reports the INC was the sole suspect drug. In nine cases re-exposure to the drug had taken place, leading to the recurrence of the event in eight of these patients. However, INCs are mainly used for rhinitis, and there is a known connection between rhinitis and migraine. Although representing only 0.6% of the total of case reports, international pharmacovigilance data suggest that the use of INCs may cause or trigger migraine or migraine-like headache. Further study is needed to determine if the reported association is true or not and, if so, what the possible mechanism is.