咳嗽药过量也致死

xyin77

WASHINGTON/BRUSSELS (Reuters) - U.S. health officials warned parents and doctors about Tussionex, the prescription cough medicine, saying it may have fatal side effects if used inappropriately.

The U.S. Food and Drug Administration issued an alert on Tuesday saying it had received reports that indicate doctors may be over prescribing the cough medicine made by UCB.

Some people also are taking the medicine, Tussionex Pennkinetic Extended-Release Suspension. more frequently than every 12 hours, the recommended time interval, or giving it to children under age 6, the FDA said. Tussionex is not approved for children younger than 6 years old.

The FDA said it had received numerous reports of health problems and deaths among children and adults who took Tussionex, which contains the narcotic pain reliever hydrocodone. Too much hydrocodone can cause life-threatening breathing problems.

Five deaths have been reported among children under 6 who took Tussionex since its approval in 1987, company spokesman Eric Miller said on Friday. He said then that UCB has proposed a stronger warning for the medicine following the reports of the deaths.

Miller said on Tuesday the number of deaths reported to the company for that age group remained at five.

The FDA urged doctors and patients to follow prescribing instructions and to only use a medical syringe or other device designed to measure liquid medications. Household spoons vary in size and should not be used, the FDA said.

\"There is a real and serious risk for overdosing if this medication is not used according to the labeling,\" Dr. Curtis Rosebraugh, acting director of the FDA office that regulates prescription cough medicines, said in a statement.

UCB, based in Belgium, will update the Tussionex label to address the concerns, the FDA's statement said.

\"The FDA's alert is fully in line with our efforts to make sure this product is properly used,\" a spokeswoman for UCB told Reuters, adding the company had already taken steps to clarify the label of the product in 2007.

The spokeswoman said she could not see any reason why UCB would withdraw the product as the FDA alert only addressed an improper use of the medicine.

Tussionex sales in the U.S. totaled 114 million euros ($176 million) in 2007, the spokeswoman added.
华盛顿/布鲁塞尔（路透社）——美国卫生官员警告医生和家长们，如果不正确使用镇咳药Tussionex，可能带来致命的不良反应。FDA于周二发布警告说，他们已经收到有关医生超剂量开UCB公司的镇咳药的报告。FDA说，有人服用Tussionex（Pennkinetic一种释药技术）缓释混悬液过于频繁超过了推荐的用药次数即每12h一次，还有人给6岁以下儿童服用该药。而FDA没有批准Tussionex用于6岁以下的儿童。他们收到许多儿童和成人服用Tussionex后引发健康问题甚至死亡的报告，因为Tussionex中含有麻醉镇痛剂二氢可待因酮，而过量二氢可待因酮可导致呼吸抑制从而面临生命危险。
UCB公司发言人Miller说，自1987年上市以来，共有5例6岁以下儿童服用Tussionex致死的报道，之后，UCB建议服用该药应当异常谨慎。截至目前，报告给UCB公司的六岁以下儿童服用Tussionex致死的病例仍然维持在5例。
FDA敦促医生和患者按照说明书并且仅用医用注射器或者液体制剂的专用医疗器械使用，不同型号的家用匙禁止使用。监管镇咳药的FDA办公室主任Rosebraugh博士说，如果不按照标签使用，药物过量真得非常危险。总部在比利时的UCB公司，将修订Tussionex的标签以引起公众的重视。
UCB的女发言人告诉路透社，FDA的警告与公司确保产品正确使用的努力是完全一致的，在2007年，公司就已经采取措施使产品的标签更加清晰。她认为UCB没有理由召回产品，因为FDA的警告仅仅表明正确使用该药。该发言人还补充道，Tussionex2007年在US的销售额达到1.14亿欧元（1.76亿美元）。

联合早报 http://www.zaobao.com/gj/gj080313_507.shtml
（华盛顿路透电）美国食品与药物管理局（FDA）在接获报告，指咳嗽药Tussionex会引发严重副作用甚至造成死亡之后，于周二发出警告，提醒人们不要过量服用该咳嗽药。
　　食品与药物管理局说，这些报告显示，医生有时会开出比建议量还多的剂量，或病人有时会超量服用Tussionex。
　　此外，有些病人服药的时间也过于频密，而没有按照指示，间隔至少12小时才服用一次Tussionex。另外，也有人让6岁以下孩童服用该药。
　　食品与药物管理局提醒说，Tussionex不适合6岁以下孩童服用。
未在新加坡注册
　　另据本报向卫生科学局查询，当局表示该咳嗽药水并没有在新加坡注册


Tussionex可能是二氢可待因酮与马来酸氯苯那敏的复方制剂。不论是哪种药物，都应遵照说明书上的用法用量使用