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首页> 外文期刊>Canadian Medical Association Journal: Journal de l'Association Medicale Canadienne >Re-examining our approach to the approval and use of new drugs.
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Re-examining our approach to the approval and use of new drugs.

机译：重新审视我们的方法批准和使用的新药物。

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In this issue, Bellini and colleagues report on a preterm infant who experienced pulmonary hypertension after receiving L-Iysine ibuprofen therapy for patent ductus arteriosus. Their case report is yet another reminder that therapies can have unforeseen adverse reactions, and it also highlights the importance of continued surveillance after a new therapy or technology is introduced. Rare adverse reactions are seldom detected by clinical trials, and they are usually only discovered years after the therapy has been adopted as routine care, as the number of patients receiving the drug increases. In many cases, the adverse drug reactions are not severe or life-threatening, and the issue never enters the public domain. Occasionally, however, the effects are highly injurious or life-threatening and patients are harmed, in which case the social, ethical and economic fallout following public disclosure can be severe and long-lasting. The recent Vioxx affair is a case in point. But how common are these adverse drug reactions, and how soon after a new drug is introduced are they usually detected? Lasser and colleagues recently reported that of 548 new drugs approved by the US Food and Drug Administration (FDA) between 1975 and 1999, 56 (10.2%) acquired a black box warning and 16 (2.9%) were withdrawn from the market. This translates into a 20% probability of a new drug acquiring a black box warning or being withdrawn from the market over a 25-year period. Half of these warnings and withdrawals occurred within 7 years of the drug's introduction, and half of the withdrawals occurred within 2 years. These data show that serious adverse drug reactions occurring after FDA approval are not uncommon and should be a cause for concern.
机译：在这个问题上,贝里尼和他的同事们报告早产婴儿肺高血压在收到L-Iysine布洛芬治疗动脉导管未闭。报告是另一个提醒,治疗有不可预见的不良反应,也强调持续的重要性监测后新疗法或技术介绍了。检测到临床试验,他们通常才发现年治疗后作为日常保健的数量接受药物的病人增加。情况下,药品不良反应并不严重或危及生命,问题永远不会进入公共领域。效果非常有害或危及生命,在这种情况下,患者受到损害社会、伦理和经济后果公开披露会严重和持久。最近的万络事件就是一个例子。这些药品不良反应是常见的,不久之后一种新药介绍如何通常检测什么?报道称,548年美国批准的新药食品和药物管理局(FDA)在1975年到1999年,56例(10.2%)获得了黑盒警告和16个(2.9%)被撤出市场。这转化为20%的概率一个新的药物获得或被黑盒警告在25年内退出市场。这些警告和提款发生的一半在7年的药物的介绍,一半的取款2年内发生。这些数据表明,严重的药物不良FDA批准后不发生反应不常见的,应该引起关注。

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