Adverse reactions to oncologic drugs: spontaneous reporting and signal detection

Abstract

Oncology is one of the areas of medicine with the most active research being conducted on new drugs. New pharmacological entities frequently enter the clinical arena, and therefore, the safety profile of anticancer products deserves continuous monitoring. However, only very severe and (unusual) suspected adverse drug reactions (ADRs) are usually reported, since cancer patients develop ADRs very frequently and some practical selectivity must be used. Notably, a recent study was able to identify 76 serious ADRs reported in updated drug labels of oncologic drugs and 50% of them (n = 38) were potentially fatal. Of these, 49 and 58%, respectively, were not described in initial drug labels. The aims of this article are to provide an overview about spontaneous reporting of ADRs of oncologic drugs and to discuss the available methods to analyze the safety of anticancer drugs using databases of spontaneous ADR reporting.

A novel co-drug of aspirin and ursolic acid interrupts adhesion, invasion and migration of cancer cells to vascular endothelium via regulating EMT and EGFR-mediated signaling pathways: multiple targets for cancer metastasis prevention and treatment

“…Our in vivo study also suggested Asp-UA possessed higher anti-metastasis efficacy with lower toxicity in comparison with UA or Asp alone. Oncologic therapeutic agent of high-efficiency and low-toxicity is an area of unmet clinical need [51]. The present study indicated that Asp-UA was effective in prevention and treatment of breast cancer metastasis, especially low toxic to the hosts, which could manifest a high clinical value.…”

Targeted therapies and adverse drug reactions in oncology: the role of clinical pharmacist in pharmacovigilance

“…A shift in the trend of reporting ADRs by health professionals and patients is considered to be an important element to improve patient’s safety and adherence to targeted therapies. The involvement of patients in Pharmacovigilance reporting systems (PVRS) is a potential strategy to increase the knowledge of oncological ADRs, increase patient’s satisfaction, and reduce the phenomenon of under-reporting [ 8 – 10 ].…”

Pharmacovigilance in oncology

“…Pharmacovigilance is today structured in complex communication systems, registries and databases. It is the fundamental approach for the early detection of new signals of risk for patients taking drugs [ 2 ]. Pharmacovigilance involves the detection and spontaneous reporting of adverse drug reactions (ADRs) occurring during drug therapy.…”