Expert opinion on drug safety
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Cancer immunotherapy encompasses a wide range of treatment modalities that harness the anti-tumor effects of the immune system. Some immunotherapies broadly activate the immune system while others precisely target distinct tumor antigens. Because of this heterogeneity, the side effects associated with immunotherapy can be mild and localized or more severe and systemic. ⋯ Immunotherapies are slowly becoming integrated into the standard of care in cancer treatment. Promising results using immunotherapy have been reported demonstrating complete remissions and cures in many patients with aggressive malignancies. The complexity and cost of engineering and administering of some forms of immunotherapy limit their use to distinct patient populations. High-throughput and cost-effective techniques are being used to broaden the applications of immunotherapy to treat cancer patients.
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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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Expert Opin Drug Saf · Mar 2019
ReviewCurrent state of biologic pharmacovigilance in the European Union: improvements are needed.
Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010. ⋯ Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.
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Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and sst5 receptors. Its longer half-life offers the convenience of 4-week dosing over the need for frequent injections of short-acting somatostatin analogues. ⋯ Expert opinion: Lanreotide is highly effective in managing carcinoid symptoms and has a robust anti-tumor effect in NET. Overall, it is well tolerated with low rates of treatment discontinuation due to toxicity. It's toxicity profile is mostly predictable, and patients should be informed of the transient nature of some of the upfront toxicities.
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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.