主页 > 医学文档 >
【medical-news】FDA宣告希爱力、艾力达、万艾可修
Potential risk of sudden hearing loss with ED drugs to be displayed more prominently
FDA宣告希爱力、艾力达、万艾可修改药品标签
进一步显示抗ED药物引发突发性听力损伤的潜在风险
The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.
FDA已经批准包括希爱力、艾力达、万艾可在内的ED药物修改药品标签（说明书），以更加显著地标明该类药物引起突发性听力损伤的潜在风险，同时指导服药者在遭遇听力问题时应该采取的措施。
In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.
另外，FDA计划要求Revatio也作出同样的标签修改，该药也属PDE5抑制剂（成分与万艾可相同），用于治疗肺动脉高压。
The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
很少量的患者在服用PDE5抑制剂后报告了突发性的听力损伤，有时伴有耳鸣和眩晕。FDA在收到这些报告后，要求该类药品制造商修改药品标签。
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
FDA医学和科学项目委员会主任，药品评价中心主任，首席医学官Janet Woodcock, M.D.说，“因为一些程度的听力丧失常常与老化过程有关，所以服用此类药物的患者可能不会因为听力问题想起向医生咨询”，
Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.
正在服用希爱力、艾力达、万艾可遭遇了突发性的听力损伤应该立即停止服用药物，并立即给于医疗观察。服用Revatio的患者应该延续其治疗，但应该立即与医疗服务提供者联系，进行进一步的治疗评估。因为Revatio用于治疗威胁生命的疾病，所以FDA不建议立即突然停止治疗，但遇到突发性的听力问题应该立即咨询医生。
A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.
2007年4月Journal of Laryngology & Otology杂志上一篇涉及服用万艾可男性遭遇听力损伤的个案报道促使FDA就有关听力损伤和PDE5抑制剂问题立即检索了不良反应报告系统，FDA发现了总共29例突发性听力损伤的药品上市后病例报告，听力损伤伴发/不伴发耳鸣、眩晕等症状，可以是部分，或者是完全的听力丧失，约1/3患者是暂时性的，剩下的患者在病例报告提交时听力损伤仍在发生，或者最后结局没有被描述。
Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.
虽然因果关系未被证实，但是此类药物与突发性听力损伤的显著关联证明修改此类药品的标签是正当的。
F DA宣告希爱力、艾力达、万艾可修改药品标签
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-06-01 17:11
医学,生命科学网