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【medical-news】FDA：尚无婴幼儿的感冒及止咳药物
FDA Rules That Over-the-Counter Cough and Cold Medicines Shouldn't Be Given to Kids Younger Than 2
FDA：尚无婴幼儿的感冒及止咳药物
FDA规定OTC感冒及止咳药不适用于2岁以下儿童
By Miranda Hitti
WebMD Medical News
Reviewed by Louise Chang, MD
Jan. 17, 2008 -- The FDA today urged parents and caregivers not to give over-the-counter (OTC) cough and cold medicines to children younger than 2 because of dangerous side effects.
2008-1-17——FDA今天发出通知，要求家长和儿童看护人员不要将OTC（非处方）感冒止咳药给2岁以下儿童服用，以免出现副作用。
"We strongly recommend that over-the-counter cough and cold products should not be used in infants and young children under 2 years of age because serious and potentially life-threatening side effects can occur from use of these products," Charles Ganley, MD, director of the FDA's Office of Nonprescription Products, said at a news conference.
FDA非处方药品办公室主任Charles Ganley医学博士在记者会上说：“我们强力建议不要给2岁以下的儿童服用OTC感冒和止咳药物，因为它们可能带来严重的副作用，甚至危及生命。”
OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.
OTC感冒和止咳药物包括用于控制感冒症状的血管收缩剂、化痰药、抗组胺药及止咳。
An FDA news release states that rare, serious adverse events -- including convulsions, rapid heart rates, decreased levels of consciousness, and death -- have been reported with use of cough and cold products.
FDA发布的消息称：目前已有使用感冒和止咳药物后出现严重不良反应的报道，其中包括惊厥、心动过速、神志不清及死亡。
The FDA is still reviewing the use of cough and cold medicines in children aged 2-11.
对于2-11岁年龄段儿童能否使用感冒和止咳药物，FDA还在审查研究。
FDA Timeline
Today's FDA recommendation is in line with the findings of an FDA advisory panel that weighed in on the topic last October, shortly after makers of OTC cough and cold drugs for infants voluntarily took those products off the market.
FDA相关事件
无独有偶，不久前生产儿童OTC感冒止咳药的公司已经自动召回了这些产品。之后的十月份，介入该问题的F DA咨询小组也得出了和FDA所发表建议的相同结果。
A key concern has been the potential for accidental overdoses if the dosing instructions for those drugs aren't followed exactly as instructed.
最关键的还是担心这些药物在使用时没有按照剂量要求而过量服用所导致的潜在危害。
"I will point out that the FDA has never endorsed the use of these products in children less than 2 years of age," Ganley says. "We've always acknowledged that there was no safety and efficacy data. It was really left to the discretion of health providers to determine whether use of one of these products was appropriate in these age groups."
“我必须指出，FDA从没有许可过这些药物可以在2岁以下的儿童中使用，”Canley说。“我们一直认为目前还没有关于药物安全性和疗效的资料。在这个年龄段中使用这些药物，只能完全依靠医务人员的判断能力。”
Ganley says the FDA decided to issue today's advisory after learning of recent surveys that show that some parents aren't aware of the warnings issued last fall about the use of OTC cough and cold drugs in kids younger than 2.
Ganley说，FDA是在调查发现有些父母并不知晓去年秋季发布的关于2岁以下儿童使用OTC感冒止咳药的警示后才决定作出今天的通知。
"This announcement will bring this issue back into the public consciousness, particularly since it's cold season now," Ganley says.
Ganley说：“现在正值感冒流行季节，这个通告能再次唤起公众注意。”
Industry Responds
The Consumer Healthcare Products Association (CHPA), a trade group representing makers of over-the-counter (OTC) medicines, issued a statement supporting today's FDA's decision.
业界反应
作为OTC药的行业组织——医疗保健产品消费协会（CHPA）也发表了声明支持FDA今天的决定。
"Safety has always been and continues to be our top priority," says CHPA President Linda Suydam, DPA.
CHPA会长Linda Suydan公关管理博士说：“安全一直是，也将继续是我们的头等大事。”
"Today's decision by the FDA reaffirms the correct course of action taken by the leading makers of these medicines last fall," says Suydam, referring to the voluntary withdrawal of over-the-counter cough and cold drugs for infants.
在谈及儿童OTC感冒止咳药物的召回时，Suydam说：“FDA今天的决定进一步说明上个秋季那些领头的制造商的行动是完全正确的。”
The CHPA is working with retailers, doctors, and the FDA "to ensure that parents have the tools they need to safely and appropriately administer OTC oral cough and cold medicines to children over the age of two," Suydam says.
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作者:admin@医学,生命科学 2011-08-12 17:22
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