Citation

Naing C, Aung K, Ahmed SI, Mak JW. Drug Healthc. Patient Saf. 2012; 4(1): 87-92.

Copyright

(Copyright © 2012, Dove Press)

DOI

10.2147/DHPS.S34493

PMID

unavailable

Abstract

BACKGROUND: For all medications, there is a trade-off between benefits and potential for harm. It is important for patient safety to detect drug-event combinations and analyze by appropriate statistical methods. Mefloquine is used as chemoprophylaxis for travelers going to regions with known chloroquine-resistant Plasmodium falciparum malaria. As such, there is a concern about serious adverse events associated with mefloquine chemoprophylaxis. The objective of the present study was to assess whether any signal would be detected for the serious adverse events of mefloquine, based on data in clinicoepidemiological studies.

MATERIALS AND METHODS: We extracted data on adverse events related to mefloquine chemoprophylaxis from the two published datasets. Disproportionality reporting of adverse events such as neuropsychiatric events and other adverse events was presented in the 2 × 2 contingency table. Reporting odds ratio and corresponding 95% confidence interval [CI] data-mining algorithm was applied for the signal detection. The safety signals are considered significant when the ROR estimates and the lower limits of the corresponding 95% CI are ≥2.

RESULTS: Two datasets addressing adverse events of mefloquine chemoprophylaxis (one from a published article and one from a Cochrane systematic review) were included for analyses. Reporting odds ratio 1.58, 95% CI: 1.49-1.68 based on published data in the selected article, and 1.195, 95% CI: 0.94-1.44 based on data in the selected Cochrane review. Overall, in both datasets, the reporting odds ratio values of lower 95% CI were less than 2.

CONCLUSION: Based on available data, findings suggested that signals for serious adverse events pertinent to neuropsychiatric event were not detected for mefloquine. Further studies are needed to substantiate this. © 2012 Naing et al.

Language: en

Keywords

human; suicide; systematic review; review; epilepsy; drug induced disease; hallucination; paranoia; gastrointestinal symptom; malaria; doxycycline; convulsion; drug safety; drug efficacy; delirium; epileptic state; chemoprophylaxis; treatment response; auditory hallucination; delusional disorder; focal epilepsy; consciousness disorder; skin disease; clinical assessment; abnormal behavior; mefloquine; visual hallucination; grand mal seizure; chloroquine plus proguanil; atovaquone plus proguanil; Mefloquine; illusion; febrile convulsion; clonic seizure; tonic seizure; delirium febrile; delusional perception; Neuropsychiatric events; nonmedical occupations; Reporting odds ratio; Signal detection; traveler