Expert opinion on drug safety
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Expert Opin Drug Saf · May 2010
Review Comparative StudyHeadache and medication overuse: are clinical case series appropriate to reveal differential risks of different medications?
The question of whether different migraine and headache medications show a differential risk of medication overuse headache (MOH) induction has been discussed extensively but has not been definitively answered to date. ⋯ Despite several different attempts to obtain direct or indirect answers from clinical case series, the fact is that due to the intrinsic selection bias, confounding and other limitations inherent to clinical case series, they are not suitable to answer this question reliably. Thus, the repeated claims of a differential risk of different drugs and drug groups are simply not scientifically sound.
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Expert Opin Drug Saf · Mar 2010
ReviewThe cardiac safety of trastuzumab in the treatment of breast cancer.
Trastuzumab has become a mainstay in the treatment of women with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the metastatic and adjuvant settings. Although trastuzumab is generally well tolerated, cardiac toxicity has emerged as a rare but potentially serious complication that limits its use in some patients. It is critically important to understand the nature of this cardiac risk when counseling patients, especially as new anti-HER2 agents are developed and tested in combination with trastuzumab. ⋯ The majority of trastuzumab-related cardiac events observed have been asymptomatic declines in left ventricular ejection fraction. The incidence of severe congestive heart failure and cardiac death observed in the large adjuvant trastuzumab trials ranges from 0.6 to 4%. Both symptomatic and asymptomatic events are largely reversible and manageable; however, little is known about the significance of asymptomatic left ventricular ejection fraction decline and longer cardiac follow-up is needed. Close cardiac monitoring must be performed for all patients receiving anti-HER2 agents currently in the clinic or in development.
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Expert Opin Drug Saf · Mar 2010
ReviewRemifentanil, a different opioid: potential clinical applications and safety aspects.
Opioids play an important role in every aspect of modern anesthetic practice. Remifentanil is an ultra-short-acting opioid featuring a unique pharmacokinetic profile allowing clinical versatility and improved control of its action. In this review, we assess the pharmacology of remifentanil, its clinical uses as well as safety issues on its action on the major organ systems and in particular clinical settings. ⋯ Remifentanil is a valuable opioid in the armamentarium of the clinician, providing great clinical flexibility and safety but vigilance is required to avoid pitfalls.
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Expert Opin Drug Saf · Jan 2010
Clinical outcomes and nephrotoxicity associated with vancomycin trough concentrations during treatment of deep-seated infections.
Higher vancomycin concentrations are thought necessary for treatment of deep-seated methicillin-resistant Staphylococcus aureus (MRSA) infection, yet this may result in greater risk of nephrotoxicity. We evaluated the relationship of serum vancomycin trough concentration with clinical outcomes and nephrotoxicity for patients with deep-seated MRSA infection. ⋯ Clinical outcomes did not differ significantly between high and low trough groups for deep-seated MRSA infections. Nephrotoxicity was consistently higher in the high trough group, regardless of the definition used.
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Expert Opin Drug Saf · Nov 2009
ReviewRenal adverse effects of nonsteroidal anti-inflammatory drugs.
NSAIDs depress prostaglandins synthesis through inhibition of COX-1 that is involved in maintaining cell integrity and COX-2 that, although presents particularly in the kidneys, is overexpressed in response to inflammation. Both the beneficial and side effects of NSAIDs are, therefore, through their inhibition of COX enzymes. Introduction of COX-2-selective inhibitors has improved the safety profile of the drugs with regard to their most common side effect which occurs at the gastrointestinal level but has not rendered them less cardio-nephrotoxic. ⋯ There is no known predictor for the nephrotoxicity. However, a relationship has been found between high plasma concentration and the renal adverse effect of NSAIDs. The usefulness of therapeutic drug monitoring in patients with risk factors needs to be explored.