Abstract
Introduction: Adverse drug reactions (ADRs) are unpredictable manifestations that can occur following the use of medications, caused by either the drugs themselves or the excipients in their formulations. Excipients are substances that contribute to the enhancement of organoleptic characteristics of the medication. However, some excipients have the potential to cause ADRs, particularly in individuals with genetic predispositions. Objective: To analyze possible adverse reactions caused by excipients present in standardized injectable medications provided by a public hospital during a specified period. Methods: This was a quantitative and descriptive study conducted in two stages: the first stage involved a systematic review of databases (BVS, LILACS, SCIELO, MEDLINE, and PUBMED) covering a 20-year period (1998 to 2018). The search used keywords such as adverse effect, adverse reaction, allergy, injectable drug, and excipients. All publications discussing adverse reactions to excipients with case reports were included. The second stage consisted of a survey of the list of standardized injectable medications available in a general hospital in the interior of Bahia, Brazil, during December 1-30, 2018, and an analysis of their composition. The list of medications and their respective package inserts were collected from available specialties to identify excipients potentially causing adverse reactions, in comparison with the evidence obtained from the literature. Results: A total of 146 articles were found, of which only 51 met the inclusion criteria. In the survey conducted in the hospital pharmacy, out of 27 injectable medications available, 12 revealed excipients capable of causing adverse reactions. These results were correlated with clinical manifestations found in the literature related to these excipients. Benzyl alcohol, one of the identified excipients, causes "Gasping syndrome," allergic dermatitis, cardiovascular collapse, and seizures. Mannitol causes shortness of breath, altered consciousness, tachycardia, swelling, blistering rash, and severe hypersensitivity. Propylene glycol leads to central nervous system disturbances, cardiac arrhythmias, respiratory depression, and renal failure. Parabens cause eczema, urticaria, and itching. Macrogol induces hypotension, vomiting, diarrhea, hypotonia, facial angioedema, and uvular edema. Additionally, excipients like lactose, povidone, metacresol, sodium benzoate, lecithin, sesame oil, and sulfites also showed severe clinical manifestations. The most common reactions reported in case studies were dermatitis and hypersensitivities. Conclusion: This study highlights the importance of pharmacovigilance regarding excipients present in medication formulations, as they can cause adverse reactions that may be incorrectly attributed to the drugs themselves or the exacerbation of the underlying disease by healthcare professionals.
