Issues of drug regulation and safety are a familiar concern within the pharmaceutical industry and often do not emerge until several years after a drug has been on the market. The antifibrinolytic drug aprotinin (Trasylol) was developed by Bayer Pharmaceuticals and approved to prevent excessive bleeding in patients undergoing coronary artery bypass grafting surgery. After several years of wides...

Abstract Overview of: Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review. Drug Safety Update 2021;14(6):1.

Systems pharmacology modeling and pharmacokinetic-pharmacodynamic (PK/PD) analysis of drug-induced effects on cardiovascular (CV) function plays a crucial role in understanding the safety risk of new drugs. The aim of this review is to outline the current modeling and simulation (M&S) approaches to describe and translate drug-induced CV effects, with an emphasis on how this impacts drug safety ...

Cenobamate is a novel antiseizure medication approved by the U.S. Food and Drug Administration European Medicines Agency, offering new therapeutic option for drug-resistant focal onset seizures. exhibits dual-mode activity, inhibiting persistent sodium currents enhancing inhibitory GABAergic synaptic transmission through allosteric modulation, thereby contributing to its antiepileptic effects. ...

Some drugs eventually have to be removed from the market because of a negative benefit-to-harm ratio, including an excess of mortality. Drug safety is the result of multiple factors, commencing with how clinical trials are designed, the information generated by and/or hidden through these trials, trial analysis by drug regulatory authorities (DRAs) and the amount of information that DRAs choose...

lamotrigine is a safe anti-epileptic drug among pregnant and lactating women. some concerns exist regarding the safety of lamotrigine during breastfeeding and related neonatal complications. in this brief review, this matter was evaluated and discussed. in this review study, the medical literature available in search databases such as embase, scopus, pubmed, and medline and even also local medi...

BACKGROUND Drug safety issues represent a major cause of morbidity and mortality. Alerting programs are intended to identify patients at potential risk for adverse drug reactions and may provide relevant information to prescribers to support their decision making about clinically appropriate risk reduction. Geographic differences in the incidence of drug safety issues and the responsiveness of ...

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BACKGROUND The problem of drug safety will never disappear as new drugs are delivered in increasing numbers. They have high biological activity and adverse drug reactions (ADR) [1]. Currently, adverse drug reactions are the fourth leading cause of death for patients.There are databases of ADRs (Vigibase, Eudravigilance), but we know that ADR manifestations may vary in different countries and re...