Drug-induced tics: An observational postmarketing study.

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Neuroscience

Background:

• Drug-induced tics are a known concern, particularly with certain drug classes.
• The strength and direction of these associations require further investigation.

Purpose of the Study:

• To investigate the association between tics and drug exposure.
• To analyze data from two major pharmacovigilance databases.

Main Methods:

• Descriptive clinical analysis of the French pharmacovigilance database (FPVD).
• Disproportionality analysis using reporting odds ratios (ROR) in VigiBase® (WHO pharmacovigilance database).

Main Results:

• Significant associations with tics were found for methylphenidate, montelukast, aripiprazole, risperidone, and venlafaxine.
• Methylphenidate showed the highest association (ROR 37.54).
• Montelukast exhibited a strong signal (ROR 12.18), previously unreported.

Conclusions:

• Confirms potential harmful associations between tics and methylphenidate, aripiprazole, risperidone, lamotrigine, and venlafaxine.
• Highlights a novel, strong association between montelukast and tics.
• Emphasizes the importance of pharmacovigilance in identifying drug-induced adverse events.