– Department of Pharmacy, Medical Security Center, Chinese People’s Liberation Army General Hospital, Beijing, Beijing, China
Background: With the development of ADR monitoring work , severe ADR has become the focus of clinical adverse drug reaction monitoring, but there are few large sample studies on serious neurological adverse reactions. This study retrieved reports of severe nervous system adverse reactions in the database of an ADR monitoring center, aiming to provide clinical rational drug use.
Objectives:
Objective: To study the characteristics and regularities of the severe drug -induced neurological disorders, to explore the risk signals of drug-induced epileptic seizures, and to provide scientific references for clinical safe medication
Methods:
Methods: The spontaneous reports of drug-induced neurological adverse reactions from 2008.01 to 2021.06 were extracted from an ADR database for retrospective study. The gender, age, clinical manifestations and pathogenic drugs of the target patients were analysed.
Results:
Results: Among the 863 cases of severe neurological adverse reaction reports, 406 cases（47.05%）were males，457 cases（52.95%）were females. The main clinical manifestations were epileptic seizures(27.35%), dizziness(22.25%), involuntary muscle contraction(11.70%),headache(9.04%), and disturbance of consciousness(4.75%). The top three pathogenic drugs are antibacterial agents, nervous system drugs, and antineoplastics. Imipenem and levofloxacin generate positive risk signals for seizures.
Conclusions:
Conclusion: Drug-induced severe neurological adverse reactions involve a wide range of drugs, of which antibacterial agents account for the highest proportion. The clinic should be alert to the neurotoxicity of drugs in elderly patients.
