Expert opinion on drug safety
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Expert Opin Drug Saf · May 2011
ReviewChemotherapy-induced peripheral neuropathies: from clinical relevance to preclinical evidence.
Chemotherapy-induced peripheral neuropathies (CIPN) are major dose-limiting side effects of many anticancer drugs. The incidence of CIPN varies from 10 to 100% depending on the anticancer drug. The characteristics of CIPN are related to dose intensity, cumulative dose and anticancer drug. CIPN can profoundly affect the quality-of-life, often compelling clinicians to lower the chemotherapy regimen, consequently limiting therapeutic efficacy. ⋯ Neurotoxic anticancer drugs can affect specific peripheral nervous system structures (neuronopathy, axonopathy or myelinopathy) leading to CIPN, often with pain. Gaining deeper insights into neurotoxic mechanisms is critical to the development of new CIPN treatment and prevention strategies.
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Expert Opin Drug Saf · May 2011
ReviewSafety evaluation of aprepitant for the prevention of chemotherapy-induced nausea and vomiting.
Aprepitant is the only neurokinin (NK(1)) receptor antagonist (RA) approved for prevention of chemotherapy-induced nausea and vomiting (CINV). Aprepitant is co-administered with a 5-HT(3) RA and a corticosteroid. Although aprepitant is safe, in most clinical settings potential drug-drug interactions need to be considered before prescription. ⋯ The recommended antiemetic regimen of aprepitant, a 5-HT(3) RA and a corticosteroid is safe. The combination of aprepitant, a 5-HT(3) RA and dexamethasone is now the gold standard of antiemetic treatment in prevention of CINV induced by HEC, or by the combination of an anthracycline and cyclophosphamide. The intravenous formulation of aprepitant used as a single dose is expected to be of benefit to cancer patients.
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Conventional systemic therapies for psoriasis are associated with serious toxicities that can limit long-term use. In recent years, biological therapies have offered the possibility of long-term therapy with improved safety and efficacy for the treatment of psoriasis. Biological therapies can be classified into three categories: the T-cell modulating agents (alefacept and efalizumab), the inhibitors of TNF-α (adalimumab, etanercept, infliximab) and the inhibitors of IL-12 and -23 (ustekinumab). Efalizumab is a humanized recombinant monoclonal IgG1 antibody. It targets multiple stages in the immunopathogenesis of psoriasis: initial T-cell activation, migration of T-cells into dermal and epidermal tissues, and T-cell reactivation. On 19 February 2009, the Committee for Medicinal Products for Human Use (CHMP) recommended the suspension of the marketing authorisation for efalizumab. ⋯ Although initially favorable, the safety profile of efalizumab revealed the appearance of severe adverse events in long-term treated patients. Therefore, post-marketing surveillance is essential for correct evaluation of drug potential.
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Expert Opin Drug Saf · Mar 2011
Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases.
To define better the safety profile of micafungin, an analysis of micafungin clinical trial safety data was undertaken. ⋯ Analysis of a large database demonstrated a favorable clinical safety profile for micafungin similar to other echinocandins.
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Expert Opin Drug Saf · Jan 2011
ReviewDexmedetomidine: pediatric pharmacology, clinical uses and safety.
Dexmedetomidine is an α(2)-adrenoceptor agonist with sedative, anxiolytic and analgesic properties. It is used off-label in pediatric patients due to its efficacy and lack of adverse respiratory effects. Dexmedetomidine may cause severe circulatory complications in adults. Despite its popularity, the safety of dexmedetomidine in the pediatric population has not been extensively studied. ⋯ Despite its favorable respiratory profile, dexmedetomidine may cause deleterious cardiovascular effects. Close monitoring of circulatory dynamics and judicious titration is recommended. Further studies are needed to better define adverse effects following long-term infusions as well as in special populations such as pre-term infants.