Exfoliative dermatitis; new safety signal detection regarding Meropenem in VigiBase™: A study based on WHO database

Abstract

Background Cutaneous adverse drug reactions (CADRs) account for nearly one-third of all adverse drug reactions (ADRs), and severe reactions while they are rare, can dramatically affect patients’ quality of life or even cost them their lives. While clinical trials may prove medicine’s effectiveness, they cannot give a thorough picture of the drug’s safety profile. Spontaneous surveillance and data mining techniques provide a promising complementary technique for post-marketing monitoring to detect safety signals. Objective The objective of this research was to assess the data obtained and uploaded to VigiBase about adverse medication responses affecting the skin and surrounding structures, with a specific focus on identifying any possible signals linked with Meropenem that are not currently indicated on the medicine label. Methods A retrospective study involved clinical review and data mining of patients who suffered cutaneous reactions reported to national Pharmacovigilance centers in Iraq and other countries from January 2010 to December 2021; a total of 4,510 reports were found in Iraq and filtered according to several criteria to obtain a safety signal with the most significant impact on public health. To improve the signal quality, all global cases were included in evaluating the detected signal, excluding duplicate and incomplete reports. Results In a total of 65 cases that contained Meropenem as the suspected cause of exfoliative dermatitis (ED), only 53 cases met the inclusion criteria. Assessment of the included cases proved the detection of a new unlabeled signal that links Meropenem to ED. The mean affected age was 59 years, and males outnumbered females (30:23). The combination showed to be statistically significant (IC025, 2.961; PRR025, 8.227; ROR025, 8.244), and causality assessment showed a possible relation in more than 70% of the cases. Conclusion Spontaneous reporting systems, despite their limitations, are vital to pharmacovigilance systems and the identified signal needs further research.