Expert opinion on drug safety
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Long-acting β-agonists (LABAs) added to inhaled corticosteroids (ICS) reduce symptoms, improve lung function and enhance overall asthma control. However, several studies have indicated an increased risk of asthma mortality and asthma-related serious adverse events and the FDA recently mandated restrictions to the use of LABAs in asthma. ⋯ The phenomenon of masking of inflammation by LABA if ICS dose is insufficient underscores the potential for confounding in determining real safety risks. Under-treatment with ICS and differential dosing of ICS in many trials are major factors driving the LABA safety concern. The FDA meta-analysis, when stratified for mandatory ICS use, found no significant increase in the composite outcome of asthma mortality, intubations and hospitalizations. Add-on therapy with LABA is effective and safe if the dose of ICS is adequate to treat airway inflammation. LABA and ICS given in a single device will negate the possibility of LABA monotherapy which is contraindicated. The FDA has recommended that LABAs be withdrawn when control is achieved with combination therapy but recent evidence suggests this may result in loss of symptom control.
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Expert Opin Drug Saf · Sep 2011
ReviewDrugs with anticholinergic properties: a current perspective on use and safety.
Many commonly used drugs have primary or secondary anticholinergic effects contributing to adverse outcomes ranging from mild-to-severe to potentially lethal. Anticholinergic adverse effects frequently occur with medications prescribed with other intended mechanisms of action, including antihistamines, antidepressants, and antipsychotics. Anticholinergic drugs are also the principal treatments of clinical conditions, such as urinary incontinence, that tend to occur in the elderly. Older patients and those with mental illness are particularly vulnerable to the adverse neuropsychiatric effects of anticholinergics as they may already have cognitive impairment. ⋯ Prescribers need to be vigilant for adverse anticholinergic effects, particularly in older patients. The symptoms may range from subtle cognitive impairment to delirium and may be due to the cumulative effect of multiple medications of modest antimuscarinic activity. The Anticholinergic Drug Scale and tables listing drugs with known anticholinergic properties may help in guiding clinical decision-making to reduce anticholinergic burden.
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Expert Opin Drug Saf · Sep 2011
ReviewAbuse potential and psychoactive effects of δ-9-tetrahydrocannabinol and cannabidiol oromucosal spray (Sativex), a new cannabinoid medicine.
There is a growing consensus that cannabis dependence is a substantial and underappreciated problem. The key component responsible for the euphoric effects of cannabis and its dependence potential is δ-9-tetrahydrocannabinol (THC). THC-containing cannabinoid medicines theoretically pose a risk of abuse and dependence. ⋯ In clinical trials, intoxication scores have been low and euphoria reported by only 2.2% of patients. Tolerance has not occurred, abrupt withdrawal has not resulted in a formal withdrawal syndrome, and no cases of abuse or diversion have been reported to date. A formal abuse liability study of Sativex in experienced cannabis smokers showed some abuse potential in comparison with placebo at higher doses, but scores were consistently lower than equivalent doses of THC. Evidence to date suggests that abuse or dependence on Sativex is likely to occur in only a very small proportion of recipients.
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Expert Opin Drug Saf · Jul 2011
Review Comparative StudySafety of perioperative β-blocker use: how do β-blockers compare in terms of side effects?
In the perioperative setting, there is still a high incidence of adverse cardiac events due to sudden coronary plaque rupture or oxygen supply-demand imbalance. β-Blockers play an important role in preventing these cardiac events. Discussion, however, remains on the side effects accompanying this therapy. ⋯ In perioperative care, β-blockers are recommended and can be given safely when started early in a low dose, titrated to heart rate. In the future, there could be a place for added perioperative short-acting β-blockers to further optimize heart rate control.
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Myocardial ischemia is a relatively frequent complication in patients undergoing non-cardiac surgery and β-blockers may have a protective effect. β-blockers reduce the oxygen supply:demand ratio, and exert anti-inflammatory and anti-arrhythmic effects. However, randomized trials, specifically conducted to test this hypothesis, yielded conflicting results. ⋯ We discuss the hypothesis that the protective effect of β-blockers on cardiovascular outcome differs across the different risk classes of surgical procedures, thereby explaining the conflicting evidence across studies. In particular, we examine the results of a recent meta-analysis that suggests that β-blockers may reduce mortality in patients under going high-risk non-cardiac surgery.