Risk Assessment of Metal(loid) Contamination in Psychotropic Drugs Fluoxetine and Carbamazepine Commercially Available in Brazil

Fluoxetine and carbamazepine are widely prescribed psychotropic drugs, yet few studies have quantified metal(loid) impurities in these medicines, which may pose health risks to patients. This study aimed to determine concentrations of As, Cd, Cr, Cu, Fe, K, Mg, Mn, P, Pb, Se, and Zn in brand, similar, and generic samples of fluoxetine and carbamazepine marketed in Campo Grande, Brazil. Drug samples were purchased from local pharmacies, digested with acid, and analyzed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES). Results showed that arsenic was detected only in fluoxetine samples, with concentrations ranging from 0.068 to 0.217 mg/kg, all below national and international limits. Phosphorus presented the highest levels, especially in fluoxetine, reaching up to 14,000 mg/kg, and up to 93 mg/kg in carbamazepine. Other elements such as Fe (0.07–3.03 mg/kg), Mg (0.21–259 mg/kg), K (up to 45 mg/kg), Se (up to 1.5 mg/kg), and Zn (up to 4.2 mg/kg) were also quantified, while Cd, Cr, Cu, and Pb were below detection limits. The hazard index (HI) exceeded 1 for all carbamazepine samples and for one brand, two similar, and three generic fluoxetine samples, indicating that the intake of these medications may pose potential health concerns. These findings underscore the need for stricter monitoring of metal(loid) impurities in psychotropic drugs to protect patient safety and ensure regulatory compliance.