Revue de Pharmacovigilance

Abstrait

Adverse Events Reactions Reported With the Use of a Fixed-Dose Combination of Nor-Pseudoephedrine, Triiodothyronine, Atropine, Aloin and Diazepam in Obese Mexican Patients

Cinthya Galicia-Quintanar, Cecilia Fernández de Valle-Laisequilla, Herman Soto-Molina, Eleazar Lara-Padilla, Juan Carlos Huerta-Cruz and Juan Gerardo Reyes-García

Background: Obesity is a health problem worldwide. Although the first-line intervention is implementing a comprehensive program of diet, exercise and behavior changes, some patients require additional drug treatment. Among the medications used wide and effectively for obesity in Mexico is found a combination consisting of 5 active ingredients: nor-pseudoephedrine, triiodothyronine, atropine, aloin and diazepam (Redotex®), whose rationality and safety remains controversial.

Objective: To analyze the adverse event reports received in the pharmacovigilance unit of the manufacturer company, from 2009 to 2014, in order to assess the existence of related potential safety issues.

Method: Adverse events were sorted by frequency and classified by intensity and causality. The groups mainly affected by adverse events by age and sex were determined and the pattern of comorbidities and use of concomitant drugs was defined.

Results: The number of reports recorded was 269, which corresponded to 609 adverse events. The greater frequency of reports occurred in the group of female 18-50 years old. The main adverse events were dry mouth and polydipsia. Most adverse events were classified both as mild and probable. Among 132 patients who used concomitant medications, 64 of them corresponded to the use of additional anti-obesity products.

Conclusion: Except for some cases of misuse, there were no data to suspect the existence of special safety issues related with the use of the product; thus, considering the high anti-obesity efficacy reported for the study product (Redotex®), its adverse event profile seems acceptable.