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【medical-news】去氨加压素：治疗尿床却引起死亡
WASHINGTON, Dec 4 (Reuters) - U.S. health officials alerted the public on Tuesday about the deaths of two patients who were treated with a prescription drug to control bed-wetting.
The Food and Drug Administration said it was unclear whether the drug, desmopressin, had contributed to the deaths. But the agency said nasal versions were no longer approved for treating bed-wetting and doctors should consider other options.
Desmopressin is sold under the names DDAVP Nasal Spray, DDAVP Rhinal Tube, DDVP, Minirin and Stimate Nasal Spray. Makers include Sanofi-Aventis (SASY.PA: Quote, Profile, Research) and several generic companies.
Other forms of the drug "should be used cautiously" in patients at risk of sodium imbalances that can be caused by over-hydration, the FDA said.
The agency reviewed 61 reports of patients treated with desmopressin who developed seizures related to hyponatremia, when sodium is too low. Two of the patients died.
"The direct contribution of desmopressin to the deaths is unclear," the FDA said in a notice posted at www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm. The patients who died were ages 28 and 80, FDA spokeswoman Susan Cruzan said.
Thirty-six seizure reports were associated with intranasal forms of the drug, the FDA said. Those versions should not be used in patients with hyponatremia or a history of the condition, the FDA said.
The agency also said treatment with desmopressin tablets should be stopped during episodes that may trigger extra fluid intake, including fever, recurrent vomiting, diarrhea and vigorous exercise.
Sanofi-Aventis spokeswoman Terri Pedone said the company had removed the bed-wetting use and updated the warnings and other sections in the prescribing instructions for its desmopressin products.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick and Braden Reddall)
((Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: BEDWETTING/DRUG
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http://www.reuters.com/article/health-SP/idUSN0443643620071205 U.S. warns about bed-wetting drug after two deaths
美国在两例死亡病例后，对治疗尿床的药物发出警告
WASHINGTON, Dec 4 (Reuters) - U.S. health officials alerted the public on Tuesday about the deaths of two patients who were treated with a prescription drug to control bed-wetting.
华盛顿，12月4日（路透通讯社）－美国卫生部的员周三对民众发出警告：两位患者在服用控制尿床的药物后死亡
The Food and Drug Administration said it was unclear whether the drug, desmopressin, had contributed to the deaths. But the agency said nasal versions were no longer approved for treating bed-wetting and doctors should consider other options.
(美国)食品与药品管理局说，“目前尚不明确，治疗尿床的药物－去氨基精加压素是否与死亡有关。”但是机构也说，鼻腔剂型目前已经不被允许应用于尿床的治疗，医生必需考虑其他的选择。
Desmopressin is sold under the names DDAVP Nasal Spray, DDAVP Rhinal Tube, DDVP, Minirin and Stimate Nasal Spray. Makers include Sanofi-Aventis (SASY.PA: Quote, Profile, Research) and several generic companies.
去氨基精加压素被以以下的名称贩售：去氨基精加压素鼻腔喷雾，去氨基精加压素鼻管，DDVD，弥凝和Stimate鼻腔喷雾。制造商包括赛诺菲安万特（(SASY.PA：引用，轮廓，研究以及一些基因公司。
Other forms of the drug "should be used cautiously" in patients at risk of sodium imbalances that can be caused by over-hydration, the FDA said.
“其他剂型的去氨基精加压，在存在水中毒引起钠失衡危险性的患者中应用应谨慎”，食品与药品管理局（FDA）的官员说。
The agency reviewed 61 reports of patients treated with desmopressin who developed seizures related to hyponatremia, when sodium is too low. Two of the patients died.
FDA回顾了61名使用去氨基精加压后由于低钠血症造成癫痫的患者，其中2名患者死亡。
"The direct contribution of desmopressin to the deaths is unclear," the FDA said in a notice posted at www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm. The patients who died were ages 28 and 80, FDA spokeswoman Susan Cruzan said.
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作者:admin@医学,生命科学 2011-08-28 17:17
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