路透社消息:美国食品和药品监督局(FDA),5月1日在官方网站发布通告,宣布召回制药业巨头强生公司旗下的包括泰诺林、美林等在内的多种儿童退烧降温药。
这是包括中国在内的世界各国父母最信赖、使用率最高的儿童退烧药。
路透社在第一时间报道了这则新闻,并透露美国FDA建议孩子家长停止给儿童或者婴幼儿服用强生公司生产的泰诺林和美林口服液等系列产品,强生公司已宣布开始召回。
FDA发言人称:尽管这些药物可能造成的损害近期还不可知,但召回的部分产品中存在成分、纯度等质量问题,没有达到相关的质量标准。
在进行进一步调查前,FDA强烈建议家长们停止给宝宝们服用上述产品,以免给宝宝身体造成伤害。
这次受召回的药品主要涉及某些婴儿和儿童用的液态药品,包括泰诺林,美林,仙特明和Benadryl等药品,被召回产品的完整列表可参考FDA官网。发起这次召回是由于这些产品可能存在一定缺陷,会影响药品的质量、纯度和药效。
“泰诺林”中的有效成分主要是“对乙酰氨基酚”,而这种物质存在于大量非处方药中,这使得人们很容易在不知情的情况下过量服用,大量服用会造成肝损伤,对于孩子来说,危害就更为严重。当然,针对目前正在接受调查的产品和已召回的相关药品,FDA表示,他们还将做更多的研究。有关召回涉及的范围,FDA提醒美国和加拿大等国的消费者不要使用。
附路透社原文:Johnson & Johnson's recalls infant, children's Tylenol, Motrin
WASHINGTON
Sun May 2, 2010 1:37am EDT
(Reuters) - The Food and Drug Administration on Saturday urged consumers to stop using liquid Tylenol, Motrin, Benadryl and Zyrtec medicines for children and infants after a broad recall announced by the manufacturer, although it said the chance of serious problems was remote。
Johnson & Johnson's consumer division announced a broad recall of products, including certain liquid infant's and children's Tylenol, Motrin, Zyrtec, and Benadryl products late on Friday。
A full list of the over 40 affected products made by McNeil Consumer Healthcare is available at www。
mcneilproductrecall。com
"We want to be certain that consumers discontinue using these products," FDA Commissioner Margaret Hamburg said in a statement。
"While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality。
We are investigating the products and facilities associated with this recall and will provide updates as we learn more," she said。
McNeil said it was recalling the products in consultation with the FDA after discovering manufacturing deficiencies that could affect the quality, purity or potency of the medicines。
The FDA said some of the products may not meet required quality standards, and parents and caregivers should stop administering them to children and switch to generic brands, which are not affected by the recall。
They said consumers should not administer adult strength medicine to infants or children since that could result in serious harm。
Some of the products affected by the recall may contain a higher concentration of active ingredient than specified;
others contain inactive ingredients that may not meet internal testing requirements;
and others may contain tiny particles, the FDA said。
The FDA said the chance of an adverse reaction was remote, but urged consumers to contact their doctors and the FDA if their children exhibited any symptoms。
McNeil Consumer said it was recalling all lots of the over-the-counter products。
The medicines were manufactured in the United States and distributed in the United States, Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago, and Kuwait。
It said consumers with questions about the recall could contact the company at 1-800-222-6036 or the website。
内容来源孙宏涛博客:http://my。pcbaby。com。cn/d/607659。html
标签:退烧药