Pediatric drug labeling - Improving the safety and efficacy of pediatric therapies
Pediatric drug labeling - Improving the safety and efficacy of pediatric therapies
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DOI：
10.1001/jama.290.7.905
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发表时间：
2003-08-20
影响因子：
120.7
通讯作者：
Crescenzi, T
中科院分区：
文献类型：
--
作者：
Roberts, R;Rodriguez, W;Crescenzi, T
大约50%至75%的儿科药物尚未进行充分研究，以提供适当的标签信息。1997年，美国国会通过了《美国食品药品监督管理局现代化法案》（FDAMA），以增加药品独家销售权的形式鼓励儿科药物的开发。目的从提交给FDA的儿科研究中识别新药标签信息。FDA要求对242种药物进行研究，53种药物被授予独家经营权。截至2003年1月，49种药物有露水标签。包括了截至2002年4月标签上有新儿科信息的前33种药物的研究数据。重要的标签信息进行了分析沿着与基线数据和类型的studys.Main结果测量安全性数据和儿科信息的标签drugs.Results有53项研究33种药物产品，12（23%）进行了评价，仅安全性; 23（43%），安全性和有效性;和18（34%），药代动力学和/或药效学。确定了12种（36%）药物的重要新剂量和/或安全性信息。确定了其中7种药物的新剂量信息。安全性信息定义为加巴喷丁、丙泊酚、七氟烷、利巴韦林和干扰素α-2b的组合以及各种含倍他米松的皮肤科制剂。在儿科重症监护病房，与对照组相比，接受丙泊酚治疗的患者报告的死亡百分比较高。在给予七氟烷的患者中观察到癫痫发作。与成人相比，接受利巴韦林和干扰素α-2b联合治疗的患者自杀意念的发生率增加。一个意外的高百分比的那些接受倍他米松含有皮肤科制剂有记录垂体功能减退，广告肾轴suppress.Conclusion FDAMA刺激儿科临床研究，从而提高了认识的药物的药代动力学在儿科医学，重要的剂量变化，并提高儿童服用某些药物的安全性。
Context Approximately 50% to 75% of drugs used in pediatric medicine have not been studied adequately to provide appropriate labeling information. In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which encouraged pediatric drug development by providing an incentive in the form of additional marketing exclusivity.Objective To identify new drug labeling information from pediatric studies submitted to the FDA in response to written requests.Design and Setting Between July 1998 and April 1, 2002, the FDA requested studies on 242 drugs, and 53 drugs were granted exclusivity. As of January 2003, 49 drugs have dew labels. Data from the studies of the first 33 drugs with new pediatric information on the label as of April 2002 are included. Significant labeling information was analyzed along with baseline data and types of studies requested.Main Outcome Measures Safety data and pediatric information for labeled drugs.Results There were 53 studies for 33 drug products, 12 (23%)were evaluated for safety only; 23 (43%), safety and efficacy; and 18 (34%), pharmacokinetics and/or pharmacodynamics. Significant new dosing and/or safety information was identified for 12 (36%) drugs. New dosing information was determined for 7 of these drugs. Safety information was defined for gabapentin, propofol, sevoflurane, the combination of ribavirin and interferon alfa-2b, and various betamethasone-containing dermatologic preparations. There was a higher percentage of deaths reported with patients who received propofol compared with controls in the pediatric intensive care unit. Seizures were seen in patients administered sevoflurane. Patients receiving a combination of ribavirin and interferon alfa-2b experienced an increased incidence of suicidal ideation when compared with adults. An unexpectedly high percentage of those receiving betamethasone-containing dermatologic preparations had documented hypopituitary-ad renal axis suppression.Conclusion The FDAMA has stimulated pediatric clinical studies resulting in improved understanding of the pharmacokinetics of drugs prescribed in pediatric medicine, important dose changes, and improved safety for children taking certain drugs.