Expert opinion on drug safety
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Clozapine is a distinctive antipsychotic agent, having a unique clinical profile and an idiosyncratic safety profile. More so than with other agents, the weighting of its adverse event profile is critical, in order to counterbalance its clear clinical advantages. ⋯ These include haematological (neutropenia and agranulocytosis), CNS (seizures), cardiovascular (myocarditis and cardiomyopathy), metabolic (diabetes), gastrointestinal and neuromuscular. Understanding the safety profile of clozapine allows an informed use of the agent that can maximise its clear clinical benefit and minimise the known risks.
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Expert Opin Drug Saf · May 2005
ReviewThe safety of cannabinoids for the treatment of multiple sclerosis.
The evidence for the therapeutic efficacy of cannabinoids in the treatment of multiple sclerosis (MS) is increasing but is not as yet convincing. Although several trials have reported no significant effect, the majority of the evidence which supports a beneficial effect on spasticity and pain is based on subjective measurements in trials where unblinding was likely to be a problem. The available clinical trial data suggest that the adverse side effects associated with using cannabis-based medicinal extracts (CBMEs) are generally mild, such as dry mouth, dizziness, somnolence, nausea and intoxication, and in no case did toxicity develop. ⋯ Likewise, there is no evidence to suggest that their effects on balance and motor control, or immune function, may be clinically significant. There is, however, reason to be concerned about the use of therapeutic cannabinoids by people predisposed to psychosis and by pregnant women, given the increasing evidence of their adverse effects on the fetus. In conclusion, given the modest therapeutic effects of cannabinoids demonstrated so far, and the risk of long-term adverse side effects, there is reason to be cautious about their use in the treatment of MS.
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Expert Opin Drug Saf · Mar 2005
ReviewThe risk/benefit of inhaled corticosteroids in chronic obstructive pulmonary disease.
Although inhaled corticosteroids have a well defined role in asthma therapy, their use remains controversial in nonasthmatic, smoking-related chronic obstructive pulmonary disease (COPD). Some studies have shown an effect of inhaled corticosteroids on airway inflammation in COPD, but the clinical relevance of these results is unknown. Data from five long-term, large studies, provide evidence that prolonged treatment with inhaled corticosteroids does not modify the rate of decline of forced expiratory volume in one second (FEV1) in patients with COPD and no reversibility to short-acting beta(2)-agonists. ⋯ However, only two studies found that combination therapy was more effective than long-acting beta(2)-agonists alone for symptoms and health status improvement. The long term safety of inhaled corticosteroids is not known in COPD patients but topical adverse effects, and systemic effects such as a decrease of bone density of lumbar spine and femur and cutaneous adverse effects, have been reported after three years of treatment. However, three recent observational studies found a slight increase in the risk of fractures (hip, upper extremities and vertebral) in association with high doses of inhaled corticotherapy.
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Expert Opin Drug Saf · Nov 2004
ReviewSafety of drotrecogin alfa (activated) in the treatment of patients with severe sepsis.
While severe sepsis continues to plague hospitals worldwide, new treatment modalities, including activated recombinant protein C (drotrecogin alfa, Xigris, Lilly), have become a standard treatment alternative in many institutional algorithms. Drotrecogin alfa was shown to have a beneficial effect on mortality versus placebo in the PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial (p = 0.005), but its use is not completely without risk. ⋯ After almost three years on the US market, the reported incidence of severe bleeding episodes has risen only slightly from the pre-marketing era, at that time notable for restrictive treatment protocols, devoid of at-risk patients. Drotrecogin alfa, while a promising agent for severe sepsis, requires prudent patient evaluation for bleeding risks.
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Chemotherapy-induced peripheral neurotoxicity (CIPN) is a major clinical problem because it represents the dose-limiting side effects of a significant number of antineoplastic drugs. The incidence of CIPN varies depending on the drugs and schedules used, and this can be quite high, particularly when neurophysiological methods are used to make a diagnosis. ⋯ Moreover, the earliest data regarding the neurotoxicity of some new classes of very promising antineoplastic agents, such as epothilones and proteasome inhibitors, will be discussed. Finally, the data available on neuroprotectants, evaluated in the attempt to prevent CIPN, will be summarised.