Acute Kidney Injury and Neuropsychiatric Reactions with Anti-Herpesvirus Drugs: Analysis of Spontaneously Reported Adverse Events
[1]
Zhihua Yue, Chinese Pharmacopoeia Commission, Beijing, China.
[2]
Jinhai Shi, Tianjin International Joint Academy of Biotechnology & Medicine, Tianjin, China.
Objectives: Acute kidney injury and neuropsychiatric reactions have been reported with intravenous (IV) acyclovir, oral acyclovir, valacyclovir and famciclovir. The aims of this study were to explore acute kidney injury and neuropsychiatric reactions signals with these anti-herpesvirus drugs by using the public release version of the U.S. FDA adverse event reporting system (AERS) database from 2004 to second quarter 2012. Methods: Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to predefined categories of acute kidney injury and neuropsychiatric reactions. Disproportionality analysis was used to calculate the reporting odd ratio (ROR) and corresponding 95% confidence intervals (CI) for adverse event categories, and stratified by indication. Results: IV acyclovir, oral acyclovir, valacyclovir and famciclovir were identified as the suspect medications in 8,037 reports in the FDA AERS database. Neuropsychiatric reactions were the most frequently reported ADRs. We identified a signal for acute kidney injury with IV acyclovir, oral acyclovir, valacyclovir and famciclovir (ROR 17.68, ROR 3.09, ROR 3.97, ROR 2.93, respectively), and a signal for neuropsychiatric reactions with famciclovir (ROR 2.93). Acute kidney injury and neuropsychiatric reactions were more frequently reported in patients with varicella zoster virus (VZV) infection than in those with herpes simplex virus (HSV) infection. Conclusion: The results of the present paper confirmed the higher frequency of acute kidney injury and neuropsychiatric reactions with IV acyclovir, oral acyclovir, valacyclovir and famciclovir, although more data were needed. Clinicians should stress this risk in the shared decision-making process.
Acute Kidney Injury, Neuropsychiatric Reactions, Acyclovir, Valacyclovir, Famciclovir, Postmarketing Safety Surveillance
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