Investigação de desvios de qualidade em comprimidos de tiamina (vitamina B1) devido à suspeita de ineficácia terapêutica no tratamento de condições neuropsiquiátricas

Abstract

Introduction: Thiamine supplementation for alcohol-dependent patients is one of the most important strategies for treating alcohol withdrawal syndrome and preventing and treating more serious neurological related complications. Also, it is used as adjuvant treatment for neurological conditions in geriatric patients. A municipal sanitary surveillance service from Sao Paulo requested the analysis of batches of thiamine hydrochloride tablets after complaints of therapeutic inefficacy during treatment of distinct neuropsychiatric conditions. Objective: To check if the thiamine therapeutic inefficacy complaints were associated to the medications’ quality. Method: Fiscal analyses were performed including aspect, weight variation, identification and potency of thiamine hydrochloride, uniformity of unitary doses and dissolution. Results: There was no quality deviation in the medications, as all performed assays presented satisfactory results. Conclusions: The administration of quality medications is essential for obtaining expected clinical effects. Other factors not associated to the medication quality such as patients’ adherence to the treatment and poor oral absorption might be associated to the complaints.