Pharmaceutical excipients and its risk for health: a literature review

Abstract

Objectives: To identify on the literature the inducers excipients of adverse effects, describe them, highlight susceptible groups and safety advice. Methods: Narrative review of the literature from 2003 to 2013 from the databases Embase, Medline, Lilacs and Scopus. Narrative, integrative and/or systematic revisions that address adverse effects of excipients in humans and/or studies that discuss recommendations to increase safety in the use of these substances were selected. Studies that were not published in English, Spanish or Portuguese, and that did not approach excipients in medicines were excluded. The variables analyzed were: the excipients, related adverse effects, susceptible groups and safety advice. Results: On the selected articles, 48 excipients that may cause adverse effects were mentioned. Benzalkonium chloride was related to changes in ocular surface; propylene glycol, to dermatitis and central nervous system changes; sorbitol, and lactose to gastrointestinal events. The most cited susceptible groups were children, patients with allergies, patients with intolerance, and patients in eye care. Of the safety recommendations identified, the most cited were: do not use risk excipients in medicines intended to susceptible groups, to use another medicine that does not contain the excipient, warnings on labels, and pharmaceutical assessment and/or intervention. Conclusion: It appears that the information related to the excipients is important to clinical practice and that the rational use of medicines, a more appropriate labeling legislation and new formulations with more suitable excipients may establish greater safety for patients.