In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted afte...

Modern standards on system safety employ the concept of safety integrity levels (SILs). Increasing numbers of system purchasers are expecting their suppliers to demonstrate that they use the concept, so system developers are seeking to apply it. But the standards differ in their derivation of SILs and none explains the concept satisfactorily, with the result that it is often misunderstood and u...

Small molecule drugs are the foundation of modern medical practice, yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on postmarketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy....

The complex transporter-cytochrome P450 (CYP) enzyme interplay in the disposition of drugs makes it very challenging to address the safety of clinical drug interactions. Thus, two major subjects are discussed herein. First, the concept of an intravenous drug interaction study (where the perpetrator is administered intravenously or orally while the drug candidate administered intravenously) to f...

Models of fluctuating(or random) geometries provide many challenging problems. One of them is the definition and interpretation of correlation functions. The usual formulation of the correlation function as a correlator of two observables in two fixed points at some distance apart is possible only if we have a fixed system of coordinates and a metric. This may be suitable for the perturbation t...

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report m...

Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these...

BACKGROUND Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in c...

When new anticancer medications are approved, their safety profiles are often not fully understood. Oncology nurses have a responsibility to file reports of adverse drug events with safety registries such as MedWatch. If these registries receive prompt, complete, and accurate data from clinicians, agencies such as the U.S. Food and Drug Administration will have a stronger ability to detect haza...