SILVER SPRING, Maryland（路透社）12月18日——在回顾了几例罕见的肝功能衰竭及其他方面的不良反应问题后，一位美国顾问在上周五说，Sanofi-Aventis的抗生素Ketek （telithromycin）应该停止扩大市场，仅限于治疗肺炎。这意味着这家法国制药企业的Ketek将可能继续用于肺炎的治疗，但同时其曾获批的另外两个适应症——支气管炎和鼻窦炎的治疗将受到限制。
FDA顾问小组称，医生需要有这样的药物作为治疗肺炎的另一个选择，然而大多数人认为医生并不确定是否Ketek对支气管炎和鼻窦炎确实有效。因为关注到最近报道的肝功能衰竭，视力模糊等问题，顾问团成员以17比2票反对Ketek继续用于治疗，其中来自纽约Dix Hills的药物安全专家Louis Morris认为，目前并不确定在鼻窦炎和支气管炎的临床试验中，Ketek有效。FDA同时还接受了顾问小组专家以外的建议，他们以16比3票赞成Ketek继续用于治疗社区获得性肺炎。
Ketek迄今为止在美国本土一年的销售额大致有7千1百万美元，Sanofi公司称已经有90多个国家批准此药，全世界有超过2千8百万人用它治疗肺炎。在顾问小组商议过程中，公司方面据理力争Ketek对于难治性感染是医生的一个重要的选择，并且强调它与其他抗生素的安全性没有差异。
“药物在大多数严重呼吸系统感染中表现出治疗活性，” 但是，大多数顾问小组的成员则强烈要求FDA考虑使用一个黑框警告信息来警示Ketek的用药风险。有些人认为该药应仅作为临床的第二选择，而不是首选用药。
FDA批准Ketek是在2004年，当时虽然有调查发现其一个关键的安全性研究数据有被造假，但政府还是认为其他大量数据可以充分证明该药的安全。
正在负责调查Ketek案件的财政参议院委员会主席Charles Grassley此前批评了FDA的一些工作上的疏忽，一些FDA内部的评论员也开始对当初该药的顺利获批提出质疑。最近发生肝衰竭的报道倍受关注，整个9月，政府机构已经收到13例使用Ketek导致严重肝功能衰竭的报道，其中5人死亡。发生肝衰竭的病人有一半是在用药4天内就出现症状的，另外，视力模糊，意识丧失以及重症肌无力加重也有报道。FDA还收到报道称，一位使用Ketek的患者在开车时出现意识丧失不幸撞到了行人。
FDA Panel Urges Limits on Ketek Antibiotic
By Lisa Richwine
SILVER SPRING, Maryland (Reuters) Dec 18 - Sanofi-Aventis antibiotic Ketek (telithromycin) should stay on the market but use should be limited to treating pneumonia, U.S. advisers said on Friday after reviewing rare cases of liver failure and other problems.
The recommendations mean the French drugmaker likely will be allowed to keep selling Ketek for pneumonia but be barred from promoting the medicine for bronchitis and sinusitis. The drug currently is approved for all three uses.
Members of a Food and Drug Administration panel said doctors needed Ketek as an option for treating pneumonia. Many said they were unsure, however, if the drug was truly effective for bronchitis and sinusitis.
Given that concern and recent reports of liver failure, blurred vision and other problems, members voted 17-2 against continued marketing for the two less-serious conditions. They said the risks outweighed the benefits in those cases.
"I'm just not convinced the drug is effective given the clinical trials" on sinusitis and bronchitis, said panel member Louis Morris, a drug safety expert from Dix Hills, New York.
The FDA usually follows advice from its panels of outside experts. The panel voted 16-3 in favor of continued Ketek sales for community-acquired pneumonia.
U.S. sales of Ketek are about $71 million so far this year, Sanofi said. The drug is approved in more than 90 countries and has been prescribed to more than 28 million people worldwide, the company said.
Sanofi said in a statement it would discuss the recommendations with the FDA. During the panel deliberations, the company argued Ketek was an important option for hard-to-treat infections and its safety was similar to that of other antibiotics.
"This drug showed activity in the most severe of the respiratory tract infections," said Dr. Bruno Leroy, Sanofi's head of internal medicine.
Most panel members urged the FDA to consider a "black box" warning, the strongest type allowed for prescription drugs, to highlight the risks of Ketek. Some said the drug should be recommended only as a second choice.
The FDA approved Ketek in 2004 even though an investigation found a key safety study was tainted by fraud. Agency officials said other data provided adequate reassurance.
Senate Finance Committee Chairman Charles Grassley, an Iowa Republican who has been investigating the Ketek case, has criticized the FDA's actions. Some reviewers within the FDA also have questioned the basis for approval.
Recent reports of liver failure added to concerns. Agency staff said they had been told of 13 severe liver failure cases in Ketek users through September. Five of the patients died.
Some FDA reviewers said it was striking that potentially serious problems appeared soon after patients took Ketek. Half the liver failure cases started within four days. Blurred vision, loss of consciousness and exacerbations of myasthenia gravis also were reported.
One report to the FDA said a Ketek user who lost consciousness was driving at the time and fatally struck a pedestrian, agency reviewers said.
http://www.medscape.com/viewarticle/549504
编辑：蓝色幻想
