Expert opinion on drug safety
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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.
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The world of drug safety is undergoing major changes in the US, Europe and elsewhere following several major drug withdrawals, billion dollar lawsuits, NGO studies of drug safety and widespread media attention in the US. Some of the events of the past few years are reviewed along with some of the reactions and changes in the FDA and the field of drug safety followed by the author's conclusions and views on the future of drug safety.
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Fentanyl-related deaths have created havoc with public health and safety, especially in the United States. With this increasingly apparent role as a drug of abuse in cases of overdose and death, the drug has acquired the reputation of 'killer fentanyl'. Is this fear justified? ⋯ The opioid drug, fentanyl, is involved in medical cases of complications, toxic effects, addiction, abuse, overdose and death in patients, as well as abuse among healthcare professionals. The increase of fentanyl abuse is a growing public health problem that may evolve into a global problem. However, abuse patterns of legally and illegally produced fentanyl have produced confusion because media reporters and public officials often ignore important differences in the origins of the drug itself and the people who abuse it. In the light of possible fatal and nonfatal side effects, the use of fentanyl should be reconsidered, especially in view of the new opioid drugs that are now available.