Medizinische Sicherheit und globale Gesundheit
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Abstrakt

Adverse Events Reported with the Use of Mazindol in Adult Obese Mexican Patients

Cecilia Fernández del Valle-Laisequilla, Juan Carlos Huerta-Cruz, Lina Marcela Barranco-Garduño, Juan Rodríguez-Silverio, Héctor Isaac Rocha-González and Juan Gerardo Reyes-García

Background: Obesity is a pandemic disease. Lifestyle modifications as diet and exercise remain as the first-line intervention for obesity; however, many patients fail to attain adequate weight loss and require drug treatment. Mazindol is a short-term useful agent in the treatment of obesity, whose safety profile has not been analyzed in Mexican population.

Objective: The current study was performed to investigate the reports of adverse events, received in the supplier laboratory for 8 years (2009-2016) with the purpose of determine potential issues of safety, related to Mazindol (MZ1®).

Methods: Adverse events were arranged in frequency tables and stratified by intensity and causality. Subgroups of sex, age and BMI with a higher frequency of side-effects were identified, as well as the main comorbidities and concomitant medications.

Results: One thousand three hundred eighty-six adverse events from 581 reports were received from 2009 to 2016. Most of reports were generated by patients in the fourth decade of life in both groups (25.5%). The most frequent adverse events were dry mouth (17.2%), polydipsia (10.6%) and constipation (9.0%). Most of them were both mild (90.5%) and possible (59.2%). Constipation was an important cause of withdrawal.

Conclusions: Data seems to indicate that 1 mg Mazindol is well tolerated for obesity treatment and its adverse events profile is acceptable. However, it is necessary to emphasize in the use appropriate of the drug, following the dosage schedule and indications approved.