Expert opinion on drug safety
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Expert Opin Drug Saf · Dec 2017
ReviewRecommendations on managing lenvatinib and everolimus in patients with advanced or metastatic renal cell carcinoma.
There are several second-line treatment options for patients with renal cell carcinoma after first-line failure of a tyrosine kinase inhibitor, especially with the recent approvals of cabozantinib, nivolumab, and the lenvatinib plus everolimus combination. A lack of reliable biomarkers and an overall lack of prospective head-to-head comparisons make it a challenge to choose a second-line treatment in the clinic. ⋯ At the same time, the safety profile of this combination, including the rate of total and severe adverse events, the percentage of dose reductions required, and the rate of treatment discontinuation, was less favorable compared with available monotherapy options, suggesting that better management could help to maximize the activity of this combination while protecting patients from undue harm. Expert opinion: Herein, we aim to postulate multidisciplinary recommendations on the advice to offer to patients and caregivers before starting treatment and how to manage the combination from the perspective of daily clinical practice.
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Expert Opin Drug Saf · Nov 2017
ReviewSafety considerations surrounding use of treatment options for nausea and vomiting in pregnancy.
Nausea and vomiting of pregnancy (NVP) is the most prevalent medical condition during gestation, affecting up to 85% of pregnant women. Many of them hesitate to use medications due to perceived fetal risks. Areas covered: There are two main aspects to medication safety in NVP: The fetal safety of drugs used to treat NVP symptoms, and the risks of untreated NVP. ⋯ Expert opinion: Fetal safety of the doxylamine/pyridoxine combination, H1blockers and for metoclopramide has been documented. Reassuring studies on the fetal safety of ondansetron, are contrasted by some studies claiming increased teratogenicity. More studies are needed to quantify fetal risks of HG.
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While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder. ⋯ The fact that in laboratory and clinical research only certain anesthetic agents and techniques, but not others, appear to be involved, raises the problem on what is the safest and the least safe anesthetic to maximize anesthesia efficiency, avoid occurrence of adverse events, and ensure patient safety. New trends in research are moving toward the theory that neuroinflammation could be the hallmark of, or could have a pivotal role in, several neurological disorders.
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Expert Opin Drug Saf · Aug 2017
Review Comparative StudySafety of ixazomib for the treatment of multiple myeloma.
Despite a major positive impact of proteasome inhibitors (PI), such as bortezomib and carfilzomib, on the survival of patients with multiple myeloma (MM) over the last few years, their use in clinical practice is limited by the development of drug resistance, significant side-effects or constraining administration schedules. Ixazomib is the first, and for now the only, oral PI, which was approved by the US Food and Drug Administration in 2015 and by the European Medicines Agency in 2016. ⋯ Expert opinion: Ixazomib combines the comfort of oral administration, substantial clinical efficacy and a good safety profile with manageable side-effects, which mainly comprise low-grade hematological, digestive or cutaneous events, and the agent will therefore play an active part in long-term treatment strategies, both as single agent and as part of combination regimens. Ongoing phase III trials are currently defining its place in first-line, maintenance and relapse settings.
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Expert Opin Drug Saf · Jun 2017
Review Comparative StudyClinical pharmacology of neurokinin-1 receptor antagonists for the treatment of nausea and vomiting associated with chemotherapy.
Five NK-1 RA formulations are commercially available to treat the delayed phase of chemotherapy-induced nausea and vomiting (CINV) occurring between days 2-5 post chemotherapy (aprepitant oral capsule and suspension, fosaprepitant intravenous infusion, netupitant/palonosetron capsules and rolapitant tablet) but no direct comparative studies have been conducted to determine their relative clinical utility. Areas covered: Information on pharmacology and safety of the NK-1 RAs derived from PubMed showed that all bind the NK-1 receptor with high affinity and selectivity. There is substantial variation in the disposition and time course in the body of NK-1 RAs because of the differential effects of hepatic metabolism. ⋯ Consequently, aprepitant not only has a much shorter elimination half-life than netupitant and rolapitant but also a more prolific drug interaction profile. All of the NK-1 RAs are efficacious and safe, and are suitable for use in a range of different patient populations, including those with mild or moderate hepatic or renal impairment. Expert opinion: While discovery of NK-1 RAs represents a major breakthrough in CINV control, further work is needed to improve control of chemotherapy-induced nausea.