据华尔街杂志报道（Kowsmann，华尔街杂志，11/30），FDA的一个顾问小组周三以15票对1票的投票结果建议批准辉瑞公司的止痛药Celebrex用于儿童类风湿性关节炎的治疗，尽管有小组成员对该药物的长期安全性存在疑问。FDA周二宣布，在批准Celebrex用于儿童以前，辉瑞公司应对该药进行进一步研究。该药物已被批准用于治疗成人关节炎，属于包括Vioxx和 Bextra在内的COX-2抑制剂，它是该类药物中唯一没有因为增加心脏病发作和中风危险而退出市场的药物。今年辉瑞公司请求FDA批准Celebrex用于2岁和2岁以上儿童类风湿性关节炎的治疗。据FDA称，美国约有30,000 到 60,000儿童患有类风湿性关节炎，批准用于该适应症的药物包括阿司匹林、布洛芬和萘普生。尚不清楚服用该药物的儿童是否存在心脏病发作的危险（Kowsmann, 华尔街杂志, 11/29）。
该小组称，之所以推荐批准该药物，是因为需要治疗青少年型类风湿性关节炎新的药物，而Celebrex已表明具有有效疗效（华尔街杂志, 11/30）。该小组建议辉瑞公司建立登记制度，以便对服药儿童的健康指标，如血压和肾脏功能，进行30年的跟踪研究。小组成员称，该药可能使儿童在以后的生活中伴随较高的心脏病发作危险（Henderson, 波士顿环球杂志, 11/30）。来自约翰霍普金斯大学的风湿病学家、小组成员Joan Bathon说，“（小组的）感觉是短期疗效满意，短期的安全性也不是问题，但长期安全性一无所知且必须弄清楚。”辉瑞公司全球医学部副总裁Steven Romano说，“这确实并不过分，但重要的是，当他们权衡安全和效益时，效益大于风险（Bridges, AP/Newark Star-Ledger, 11/30）。”美国内科委员会副主席、小组成员Eric Holmboe批评辉瑞公司通过向FDA提交医师文件来监测药物副作用的提案。他指出采用志愿者报告系统来跟踪该药物的长期作用是一种“非常软弱的手段”（Boston Globe, 11/30）。
FDA Advisory Committee Recommends Approval Of Celebrex For Use In Children
Main Category: Arthritis News
Article Date: 04 Dec 2006 - 15:00pm (PST)
An FDA advisory panel on Wednesday voted 15-1 to recommend approval of Pfizer's pain medication Celebrex for the treatment of rheumatoid arthritis in children, even though some panel members questioned the long-term safety of the drug, the Wall Street Journal reports (Kowsmann, Wall Street Journal, 11/30). On Tuesday, FDA said Pfizer might have to conduct additional studies of Celebrex before it could be approved for use in children. The drug, which is approved to treat arthritis in adults, is the only member of a class of medications called COX-2 inhibitors, which include Vioxx and Bextra, not to have been withdrawn from the market over concerns of increased risk for heart attacks and stroke. Pfizer this year requested FDA approval for Celebrex as a treatment for rheumatoid arthritis in children ages two and older. According to FDA, about 30,000 to 60,000 children in the U.S. have rheumatoid arthritis. Drugs approved to treat the condition include aspirin, ibuprofen and naproxen. The heart attack risk for children who take the drug is unknown (Kowsmann, Wall Street Journal, 11/29).
Panel Recommendation
The panel said it decided to recommend approval of the drug because new treatments are needed for juvenile rheumatoid arthritis and Celebrex has been shown to be an effective treatment (Wall Street Journal, 11/30). The panel recommended that Pfizer establish a patient registry to track for up to three decades health indicators like blood pressure and kidney function in children who take Celebrex. Panel members said the drug potentially places children at a higher risk of having a heart attack later in life (Henderson, Boston Globe, 11/30). Panel member Joan Bathon, a rheumatologist at Johns Hopkins University, said, "The [panel's] feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known." Steven Romano, a vice president in Pfizer's worldwide medical division, said, "That's not unreasonable. But the important part, when they considered both safety and benefit, is the benefits outweighed the risks" (Bridges, AP/Newark Star-Ledger, 11/30). Panel member Eric Holmboe, vice president of the American Board of Internal Medicine, criticized Pfizer's proposal to monitor the drug's side effects through reports physicians file with FDA. He said a voluntary reporting system would be a "very weak instrument" for tracking long-term health effects of the drug (Boston Globe, 11/30).
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