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Organ-specific immune-mediated reactions to polyethylene glycol and polysorbate excipients: three case reports.

ABSTRACT: Drug-related acute pancreatitis (AP), acute interstitial nephritis (AIN) and drug-induced liver injury (DILI) are rare but serious adverse drug reactions (ADRs) that can have life-threatening consequences. Although the diagnosis of these ADRs can be challenging, causality algorithms and the lymphocyte transformation test (LTT) can be employed to help with the diagnosis. In this report, we present 3 cases of drug-related AP, AIN and DILI. The first case involved a patient with AP to lacosamide and to the excipient polysorbate 80 in pantoprazole. The second case involved a patient with DILI secondary to polyethylene glycol (PEG) excipients and amoxicillin-clavulanate. In case 3, AIN was considered to be the result of sensitization to excipients. Diagnoses were made using causality algorithms and the LTT. The LTT is a useful tool for helping diagnose drug-related AP and DILI, and it can be used to identify the specific drug or excipient causing the ADR. These cases highlight the importance of considering PEG and polysorbate excipients in the causality diagnosis of ADRs.

SUBMITTER: Rogozina O

PROVIDER: S-EPMC10792031 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Organ-specific immune-mediated reactions to polyethylene glycol and polysorbate excipients: three case reports.

Rogozina Olga O Ruiz-Fernández Carmen C Martín-López Susana S Akatbach-Bousaid Ibtissam I González-Muñoz Miguel M Ramírez Elena E

Frontiers in pharmacology 20240103

Drug-related acute pancreatitis (AP), acute interstitial nephritis (AIN) and drug-induced liver injury (DILI) are rare but serious adverse drug reactions (ADRs) that can have life-threatening consequences. Although the diagnosis of these ADRs can be challenging, causality algorithms and the lymphocyte transformation test (LTT) can be employed to help with the diagnosis. In this report, we present 3 cases of drug-related AP, AIN and DILI. The first case involved a patient with AP to lacosamide an ...[more]

PMID: 38235115

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Project description:IntroductionCOVID-19 vaccination has been a key intervention in reducing the severity of symptoms; however, concerns about vaccine safety, particularly regarding allergic reactions, arose early on. Healthcare workers faced the challenge of addressing these concerns to ensure safe vaccine administration. This study aimed to review the practical aspects of using allergy skin testing for COVID-19 vaccine excipients in patients with a history of allergic reactions developed following mRNA COVID-19 vaccination.MethodsA retrospective chart review was conducted for patients who reported allergic reactions after the COVID-19 vaccine and underwent allergy skin testing for COVID-19 vaccine excipients in the Adult Allergy and Immunology Service at Hamad Medical Corporation, Doha, Qatar. The testing protocol, developed based on published data during the pandemic, included skin prick (SPT) and intradermal (ID) testing using medications containing polysorbate 80 and polyethylene glycol (PEG), the primary excipients in the COVID-19 vaccines suspected of triggering allergic responses.ResultsOf the 88 patients reviewed, 38 reported different types of allergic reactions following mRNA COVID-19 vaccination, with the majority being female. Anaphylaxis was reported in 21.1% of the patients, while the remaining experienced less severe allergic reactions. All patients underwent SPT and ID testing with PEG and polysorbate 80. By SPT, two patients tested positive for PEG and none for polysorbate 80. By ID, seven tested positive for polysorbate 80 and one for PEG. Among patients who experienced anaphylaxis, 50% had positive allergy test results. Twenty-three percent of patients with negative test results could receive additional vaccine doses without adverse reactions.ConclusionManaging patients with a history of allergic reactions to the COVID-19 vaccine is challenging, as the exact mechanisms and accurate and valid allergy testing are yet to be determined. In our cohort, most patients had mild allergic reactions following vaccination. Excipients' allergy skin testing has helped to reduce vaccine hesitancy despite its questionable utility in clinical practice.

Project description:RATIONALE:Insulin autoimmune syndrome (IAS) is a rare endocrine disease characterized by repeated fasting hypoglycemia or episodes of hypoglycemia late after meals, elevated serum insulin, and positivity for insulin autoantibody (IAA) or insulin receptor antibody (IRA). We summarize the clinical manifestations and treatment experiences of 3 patients with IAS. PATIENT CONCERNS:One patient with >20-year history of type 2 diabetes mellitus had irregular episodes of hypoglycemia 2 years of after treatment with insulin. Another patient with a 6-year history of type 2 diabetes mellitus presented irregular episodes of hypoglycemia after 6 months of treatment with insulin. One patient with a history of Graves' disease showed hypoglycemia after administration of thiamazole. DIAGNOSIS:Serum islet cell antibody (ICA) and glutamic acid decarboxylase antibody (GADA) were negative, while antibody insulin autoantibodies were positive in all the 3 patients. Two patients demonstrated diabetes mellitus after an oral glucose tolerance test, while one had normal glucose tolerance. Furthermore, serum insulin levels significantly elevated and did not matched C peptide levels. No abnormalities were found on enhanced MRI of the pancreas, and all 3 patients were clinically diagnosed with IAS. INTERVENTIONS:In case one, insulin aspart 30 injection was withdrawn after admission. In addition, the patient was prescribed sublingual acarbose 3 times daily. Two weeks after admission, prednisone acetate was administered orally once daily at night. In case 2, insulin aspart 30 injection was withdrawn after admission, the patient was prescribed sublingual acarbose 3 times daily with a meal. Five days after admission, oral prednisone acetate was administered once daily at night. In case 3, oral propylthiouracil was prescribed and thiamazole withdrawn after admission, and the patient consumed an extra meal before sleeping. OUTCOMES:At the 3-month follow-up visit, the hypoglycemic episodes had disappeared, serum insulin levels were significantly decreased, and insulin antibody (IA) levels were no longer detectable in all 3 patients. LESSONS:For those patients with high-insulin hypoglycemia, IAA should be evaluated if serum insulin concentrations are inconsistent with C peptide levels. Therapeutically, a lower dose of glucocorticoids with more appropriate medication timing can be used to achieve good results.

Project description:PEG2000 (polyethylene glycol, molecular weight: 2000) is commonly used for the dehydration and reinforcement of waterlogged wooden cultural relics, but its photo-aging degradation will seriously affect the long-term conservation of the wooden cultural relics. In this study, the photo-aging characteristics and mechanisms of PEG2000 under UV (ultraviolet) irradiations of three wavelengths were comprehensively investigated, and the surface morphology, crystal structure, and relative molecular weight of PEG2000 were systematically characterized. The results showed that PEG2000 showed a higher gloss loss rate, carbonyl index and crystallinity, and a wider molecular weight distribution with increasing aging time, especially under the irradiation of 313 nm ultraviolet light. The evolution of the PEG2000 from surface to interior during photoaging was elucidated by SEM (scanning electron microscopy) and FTIR (Fourier transform infrared spectroscopy), and it was determined that photodegradation not only occurs on the surface of PEG2000 but also gradually extends to the interior of the sample with the prolongation of irradiation time, resulting in the transformation of the basic component unit of spherical crystals in PEG2000 from fibrous crystals to spherical particles. Based on 1H-NMR (nuclear magnetic resonance spectroscopy), the photochemical reactions for the generation of degradation products were proposed, and it was found that the degradation occurred at the C-H and C-O-C bonds on the main chain, forming a large number of ester and ethoxy structures. The aging degree of PEG2000 was evaluated from the perspective of surface morphology and chemical structure by gloss and FTIR spectroscopy, and it was found that the combination of gloss loss rate and carbonyl index was more suitable to evaluate the aging degree of the sample. The relevant theoretical research will provide reliable guidance for the preservation of polyethylene glycol in waterlogged wooden cultural relics.

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Organ-specific immune-mediated reactions to polyethylene glycol and polysorbate excipients: three case reports.

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Organ-specific immune-mediated reactions to polyethylene glycol and polysorbate excipients: three case reports.

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