阻挠婴儿服用感冒糖浆的行动仍在继续

红枸杞 · 发表于 2008-2-13 08:46:33

The movement to prevent babies from taking cold syrups continues.
转自http://www.dxy.cn/bbs/post/view? ... phubuYs46e3aEGSn-20 by davidbgb

The Food and Drug Administration recently reissued a health advisory that parents refrain from giving children under 2 years old cough and cold drugs because "potentially life-threatening side effects can occur."
食品与药品管理局近日重新发布健康劝告，父母应避免给2岁以下的儿童服用咳嗽和感冒药，因为“可能会发生潜在具有致命的副作用”。

The agency did so because parents are still medicating babies; 64% of parents with youngsters think cold remedies are somewhat safe for children under 2, says a Kaiser Family Foundation December survey.
该局之所以这么做是因为父母们仍在喂孩子这些药，Kaiser家庭基金会12月份的一份调查称，有64%的孩子父母认为，这些感冒药对2岁以下儿童在一定程度上是安全的。

The FDA's next step is to figure out what's best for kids 2 to 12. Investors can expect an announcement in the spring. What the agency will decide is anyone's guess, analysts say.
FDA下一步打算制定对2岁到12岁孩子的建议。投资者有望在春天可以看到公告。分析人士说，每个人都在猜测FDA可能做出什么决定。

If its decision is ultimately based on what doctor groups urge, the FDA might have a greater financial impact on drug makers than it's had so far.
如果FDA的决定最终是基于医务界的主张，那么它对制药商的财政影响将比以前更大。

Companies with a stake include Johnson & Johnson (NYSE:JNJ - News), maker of Tylenol and PediaCare infant drops; Prestige Brands (NYSE

BH - News), which makes the Little Remedies brand; Novartis (NYSE:NVS - News), maker of Triaminic; and Wyeth (NYSE:WYE - News), maker of Robitussin and Dimetapp.
受牵连的公司包括Tylenol（泰诺）和PediaCare婴儿滴剂的制造商强生公司，Little Remedies品牌的制造商Prestige Brands公司，Triaminic制造商诺华公司，Robitussin和Dimetapp制造商惠氏公司。

In October, companies voluntarily recalled all over-the-counter cold and cough syrups for children younger than 2. This followed a vote by the FDA's scientific advisers that the drugs don't work in small children and shouldn't be given anyone under age 6.
10月份，上述公司在全国主动召回适用于2岁以下儿童的感冒和咳嗽糖浆。这是在FDA科学顾问委员会投票认为这些药对儿童无效并且不能交给6岁以下儿童后进行的。

At Prestige, the recall's impact was most painful in its fiscal second quarter ended Sept. 30. The recall knocked 1% off net sales and helped depress earnings 22% to 14 cents a share. Organic growth was 1% vs. 2% absent the withdrawal.
在Prestige公司，截止到9月30日，召回药品对第二季度的财务影响是非常痛苦的。召回行动使净销售额下降1%，导致每股收益减少22%至14美分。内生增长率为1%，不包括召回部分为2%。

"The damage has already been done," said Suntrust analyst William Chappell. "With Prestige, the hope was that the FDA would reverse its decision and let the products come back on the shelf, but that now looks unlikely."
“损失已经发生了，”Suntrust分析师William Chappell说，“Prestige公司的希望是FDA能撤销它的决定，让产品回到销售架上，但现在看来是不可能了。”

Focus On Packaging, Prevention
关注包装和预防

When asked about J&J and Wyeth, Raymond James analyst Michael Krensavage said it's hard to quantify the recalls' impact because the companies don't break out cough drug figures. At this point, the impact isn't significant for either company, he says.
当问到强生公司和惠氏公司时，Raymond James分析师Michael Krensavage说很难量化药品召回的影响，因为这两家公司并没有把咳嗽药的数据分开出来。他说，在这一点上讲这两家公司受到的影响都不大。

If the FDA decides against cough syrup for kids 2 to 12, Prestige won't suffer any more, Chappell says. Its cough syrups are only for kids up to 2-years-old, and both remedies have already been withdrawn.
如果FDA决定反对咳嗽糖浆用于2-12岁的儿童，Prestige公司将不会受到更多损失，Chappell说。它的咳嗽糖浆只适用于2岁以下的儿童，现在所有的药都已经收回。

"Wyeth or others (such as J&J) that make bigger drugs like Tylenol would be more impacted," said Chappell, who follows Prestige.
“惠氏和其他制造像泰诺等品牌药的公司（如强生公司）受到的影响会更大”，Chappell说，他一直在关注Prestige公司。

Every year, 7,000 kids are rushed to the emergency room after overdosing on cough and cold syrups, according to a late January study in the journal Pediatrics. They make up 6% of ER visits for the age group.
依据《儿科学》（Pediatrics）杂志一月份发表的最新研究，每年有7000名孩子因过量服用咳嗽和感冒药而送进急诊室。占该年龄分组急诊量的6%。

Two-thirds of the visits were among children 2 to 5. About 80% of the time, it was due to kids gulping down syrups when parents weren't around.
三分之二的就诊儿童年龄在2-5岁。80%是因为孩子吃药时父母不在旁边。

The study offers possible solutions for drug makers.
这项研究为制药商提供了可能的解决方案。

"We could prevent unsupervised ingestions and take a large bite out of ER visits with improved packaging," said Dr. Dan Budnitz, a study co-author.
“我们可以通过改善药品包装来预防未受监督的服药，从而大大减少急诊量”，共同执笔的Dan Budnitz博士说。

He suggests child-resistant single-dose packages, caps that require adults to insert a needleless syringe to extract medicine, and colorless syrups.
他建议使用防止儿童开启的单剂量包装和瓶盖，糖浆是无色的，使用时需要成年人插入有针头注射器抽取药液。

"Even if a child is persistent or creative, he'd only be able to swallow one dose before a parent finds him," said Budnitz, a medical officer at the Centers for Disease Control.
“即使孩子有耐心或有创造性，在父母发现他之前也只能吞服一个剂量”，Budnitz说，一位疾病控制中心的医学官员。

Could such innovations help drug makers recover lost profit? No, says Dr. Ian Paul, head of pediatric research at the Penn State College of Medicine.
这样的改进能否使制药商挽回损失？不能，Ian Paul博士说，他是宾夕法尼亚大学医学院的儿科研究所负责人。

"They're not an opportunity for drug makers because the drugs have not been shown to be effective for children," he said. "No matter how they're packaged, pediatricians are still not going to recommend them."
“对制药商来说，它们并不是一个机会，因为这些药物对孩子来说没效，”他说。“不论他们怎么包装，儿科医生仍不会继续推荐它们。”

Indeed, honey is more effective than dextromethorphan, a cough syrup ingredient, according to another study published in the December issue of Pediatrics. Honey can't be used in children under 1, due to risk of infantile botulism.
实际上，按照发表在十二月份《儿科学》（Pediatrics）杂志上的另一篇研究，蜂蜜都比右美沙芬（咳嗽糖浆的一种成分）有效。因为有婴儿肉毒杆菌中毒的危险，蜂蜜不能用于1岁以下的婴儿。

"The study shows these medicines have large placebo effects, but true placebos don't have side effects. These medicines do," said Paul, lead author of the study.
“这项研究显示这些药物主要是安慰剂作用，但真正的安慰剂没有副作用，而这些药有。”文章的第一作者Paul说。

Data against cough syrups are growing. The international Cochrane Collaboration led 25 studies of 3,492 adults and children, comparing expectorants, antihistamines-decongestants and antitussives to placebo.
反对使用咳嗽糖浆的资料越来越多。国际Cochrane协作网曾牵头25项包括3492名成人和儿童的研究，拿化痰药、抗组胺药和止咳药来与安慰剂相比较。

"The evidence for effectiveness of oral over-the-counter cough medicines is weak," the authors wrote in late January.
“口服非处方咳嗽药效果的证据是无力的，”作者们在今年一月份写道。

Physicians have discouraged cough syrup use for a decade now. In 1997, the American Academy of Pediatricians said it didn't support the use of OTC cough and cold medicines in children.
医生对不主张使用咳嗽糖浆已有10年。在1997年，美国儿科研究院就已不支持儿童使用非处方咳嗽和感冒药。

In 2006, the American College of Chest Physicians said children younger than 15 shouldn't be given the syrups because they hadn't been proved effective.
在2006年，美国胸内科医师学会指出小于15岁的儿童不应该给予这些糖浆，因为它们没有被证明有效。

Cooperation Needed
需要合作

Linda Suydam, president of the Consumer Healthcare Products Association, which represents leading U.S. makers of OTC cough syrups, declined to be interviewed.
Linda Suydam，消费者保健品协会会长，代表美国非处方咳嗽糖浆制造商，拒绝采访。

"These medicines are safe when used as directed," she said in a Jan. 28 statement.
“按照说明使用这些药品是安全的，”她在1月28日的一份声明中说。

Paul suggests working with drug makers. "It's more helpful to work together," he said. "A blanket pull off the market could have negative effects, such as people giving adult medicine to kids."
Paul建议和制药商合作。“合作很有帮助，”他说。“完全撤出市场可能会造成消极作用，譬如人们可能把成人药品给小孩服用。”

davidbgb edited on 2008-02-10 21:36