2006年12月13日-美国食品和药物管理局（FDA）要求撤除包含奎宁化合物的未批准药物，此举动与其强烈的安全意识及使用这些药物后产生的死亡有关。这也是FDA下大力气从市场上撤除不安全、未被批准药物的一个表现。
从1969年开始，FDA共接收到665例奎宁类药物的严重副反应报道，其中含93名致死病例。这些数据来自昨天MedWatch公布的药物预警以及FDA安全信息和副作用汇报计划。这类药物的严重副反应包括心律失常、血小板减少和超敏反应等，而且可出现与其他药物的交叉反应。
FDA指出目前只有一种奎宁类药物（Mutual药物公司）被批准使用，只适用于治疗无并发症疟疾。但是此药物常常被用于治疗腿部抽筋或相似情况，虽然药物标签上已经说明用于此种治疗的风险性要大于治疗效果。
市场上未被批准的奎宁类药物没有标明药物提示，增加了人们不正当使用和使用FDA未批准的剂量等危险。由于它的治疗指数窄，所以必须小心使用；剂量改变和/或缺乏监测军可能导致病人的肝脏和肾脏损害。
FDA要求市场在60天内必须做好这些药物的禁售工作。但是一些以前航运商品可以在药架上短时间存放。建议消费者去健康中心咨询使用未被批准的奎宁类药物的情况。
关于奎宁治疗的副反应的情况可向FDA的MedWath报告中心致电： 1-800-FDA-1088, 传真： 1-800-FDA-0178, 或登陆网址http://www.fda.gov/medwatch,或写信给以下地址：5600 Fishers Lane, Rockville, MD 20852-9787.
FDA Removes Unapproved Quinine Drugs From Market
Yael Waknine
December 13, 2006 — The US Food and Drug Administration (FDA) has ordered the removal of unapproved drug products containing quinine, citing serious safety concerns and deaths associated with their use. The action is part of a larger effort to remove all unsafe, unapproved drugs from the market.
Since 1969, the FDA received 665 reports of serious adverse events (including 93 fatalities) associated with quinine use, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.
Serious adverse events have included cardiac arrhythmias, thrombocytopenia, and severe hypersensitivity reactions; potentially serious interactions with other drugs can also occur.
The FDA notes that only one quinine product (Qualaquin, made by Mutual Pharmaceutical Company, Inc) is currently approved by the FDA. Although indicated only for the treatment of uncomplicated Plasmodium falciparum malaria, the drug is often prescribed to treat leg cramps and similar conditions despite drug label warnings advising that the risks associated with its use in this setting outweigh potential benefits.
Unapproved quinine drug products are marketed without these drug label warnings, which increases the risk for their misuse and potential consumption of doses that have not been reviewed or approved by the FDA. Because of its narrow therapeutic index, quinine must be used carefully; dose modifications and/or close monitoring may be required for patients with hepatic or renal impairment.
Under the FDA order, all manufacturing of these products must cease within 60 days. However, some previously shipped merchandise may remain on pharmacy shelves for a short time. Consumers have been advised to contact their healthcare provider with any questions or concerns regarding their use of unapproved quinine products.
Adverse events potentially related to quinine therapy should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
http://www.medscape.com/viewarticle/549301
编辑：蓝色幻想
