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为什么一些药物订明关闭标签?

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弗里达威利,药学博士 - 博客
通过Frieda Wiley, PharmD, RPh May 29, 2020

药物的世界可以非常混乱:有数以百计的药品,其中许多人有不同的名称(品牌仿制药VS),各种优势,通过多种方式,你可以把他们(丸剂,片剂,糖浆等)。为了更加复杂的是,某些药物有时处方比FDA已经批准,实践我们的医疗人称之为其他用途“关闭标签处方。”这可以是非常混乱的病人,特别是如果你熟悉被用于特定目的的药物。

If you read medication guides (the printed handouts of drug information you receive when you pick up your prescription), you might be surprised if it does not mention the condition that your doctor prescribed it for.

你开始担心之前,先了解其关闭标签处方是相当普遍的。事实上,之间写在美国的所有处方的10%-20%是关闭标签迹象。这是因为在许多为1,每5处方。这也是完全合法的,这样做。据美国医学协会,一旦FDA批准在美国使用的药物,它可以用于任何迹象。但是,这并不意味着你的医生通过开你的药物外标签上您尝试。

One reason doctors prescribe medications for off-label use is that the drug approval process is typically a very long, difficult process that can take up to 20 years from start to finish. Drug manufacturers must conduct clinical trials to evaluate the safety and effectiveness of their drugs. Even after having completed these tests, it sometimes takes the FDA a while to approve new drugs or new indications for old drugs—even if the manufacturer had data showing benefit for another indication for a while. Sometimes, the medical community moves a little faster than the science, and off-label prescribing is an example of this.

此外,关闭标签处方可在治疗某些条件这是任何药物已被FDA批准的或有限的治疗方案存在非常有效。因为药物的工作方式有利于他们正在治疗其他条件医生可能会开药关闭标签。这是很多医生都响应现在在干什么COVID-19。正如你可能已经听说过,用于其他条件几种药物正在研究,看他们是否是针对病毒有效。这些措施包括羟氯喹(PLAQUENIL),美国食品药品管理局先前已批准用于治疗疟疾,类风湿关节炎和红斑狼疮和用于由细菌引起的,如社区获得性肺炎,急性慢性阻塞性肺病相关的感染,急性窦治疗感染的抗生素阿奇霉素的药物感染。

In another example, if you have stage fright or a fear of public speaking, your doctor might prescribe a drug called propranolol. Propranolol is not approved for anxiety, but it is approved for high blood pressure. It lowers high blood pressure by slowing the heart rate. And its ability to keep your heart from racing is exactly why it tends to help people manage their performance anxiety. In fact, doctors have used propranolol for anxiety since the 1960’s.

Sometimes, doctors prescribe an off-label drug for its side effects. For example, the drug quetiapine (Seroquel) is FDA-approved for schizophrenia and certain bipolar disorders, but because the drug causes extreme drowsiness, doctors sometimes prescribe the drug to help folks get a good night’s sleep.

However, not all off-label prescribing is effective.

也许关闭标签处方最有名的,臭名昭著或-例子是加巴喷丁(Neurontin的)。原来在90年代初批准,加巴喷丁表示为附加治疗癫痫发作或治疗疱疹相关的疼痛持续超过3个月。然而,它已被用于超出了FDA原先批准许多其他适应症。在这些用途是引起糖尿病(糖尿病神经病变),纤维肌痛,坐骨神经痛,酒精戒断神经疼痛,腰痛,只是仅举几例。事实上,它的许多其他条件频繁处方近年来,常常因为缺乏可靠的数据或确凿的证据支持这些标签外用途已经做了标题。

加巴喷丁在这些案件中的常见处方已经获得了医疗界的一些争议。有些人担心,病人可能不会得到安全有效的治疗。然而,这种药物可能是无效的标签外处方的一个极端的例子。

作为一个经验法则,可以考虑请你的医生你的新处方在离开办公室之前。它也不会伤害给附带你的处方快速读取不仅能更好地熟悉新的用药指导用药整体,还要确保你理解为什么you are taking it. But if you have questions or concerns, a nice chat with your doctor (or pharmacist) can help put your mind at ease.

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About the Author
Frieda Wiley, PharmD, RPh

弗里达威利,药学博士,RPH,是临床药师,合同医疗作家和顾问。她拥有众多的出版物,以她的信用,包括哦!奥普拉杂志,关节炎Today美国新闻与世界报道每日健康,andCostco的连接。To read more about Frieda, visit her网站或跟随她上Twitter

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