ST LOUIS (MD Consult) - On June 16, 2009, the US Food and Drug Administration (FDA) alerted consumers and health care professionals that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs (children's size) are associated with a long-lasting or permanent loss of the sense of smell (referred to as anosmia) and should therefore be discontinued and discarded. These products, marketed by Matrixx Initiatives, are over-the-counter, zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. This advisory does not pertain to oral Zicam zinc tablets and lozenges.

 

The FDA announcement states that these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms. Also on June 16, 2009, Matrixx Initiatives announced that it will comply with the FDA's requirements but will seek a meeting with the agency to vigorously defend its scientific data that demonstrate product safety, data that were gathered during more than 10 years of experience with their products. Although Matrixx Initiatives believes that the FDA action was unwarranted, the company is voluntarily withdrawing Zicam Cold Remedy Swabs and Zicam Cold Remedy Gel from the market.

 

The FDA states that it has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many persons who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. The Matrixx Initiatives' response to the FDA advisory states that since the Zicam intranasal products were first introduced in the market in 1999, more than 35 million retail units representing over 1 billion doses have been sold, and the cumulative body of scientific and medical evidence compiled over those years has demonstrated both the safety and efficacy of the products under conditions of ordinary use. According to a statement by William J. Hemelt, Matrixx Initiatives' acting president, "There is no reliable scientific evidence that Zicam causes anosmia."

 

Health care professionals may report adverse events or quality problems related to the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by telephone (1-800-FDA-1088), by fax to 1-800-FDA-0178, or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

圣路易斯(MD Consult)——2009年6月16日，美国食品药品管理局(FDA)警告消费者和医学专业人士，应立即停止使用Zicam感冒鼻腔喷剂(Zicam Cold Remedy Nasal Gel)、Zicam感冒鼻用拭子(Zicam Cold Remedy Nasal Swabs)和Zicam感冒用拭子(Zicam Cold Remedy Swabs，儿童规格)，上述药物可导致长期或永久性嗅觉失灵(anosmia)。这些产品为含锌OTC鼻用感冒药，由Matrixx Initiatives生产销售，用以减轻感冒症状的持续时间和严重程度。该警告并不包括口服Zicam锌片和含片。

 

FDA宣称，此类产品仍未被证实具有减轻感冒症状持续时间和严重程度的疗效。Matrixx Initiatives在同日宣布该公司将遵守FDA的要求，但将寻求与FDA会谈，积极捍卫历时10年收集的关于产品安全性的科学数据。Matrixx Initiatives认为FDA的做法毫无道理，公司撤回Zicam感冒鼻腔喷剂和Zicam感冒用拭子乃是自愿行为。

 

美国FDA称已接获超过130份关于服用这些药物后嗅觉失灵的报告。在这些报告中，许多发生嗅觉失灵的患者称其在接受首剂量治疗时就出现了这一情况，其他人报告嗅觉失灵发生在多次使用上述药品后。Matrixx Initiatives在一份针对FDA警告的声明中指出，Zicam鼻腔药品自1999年投放市场以来，零售已超过3,500万次，累计售出10亿份，汇集多年的科学和医学证据已经证明正常使用Zicam鼻腔药品的安全性和有效性。另据公司执行主席William J. Hemelt 的一项声明称：“尚无可靠的科学证据证明Zicam药品导致了嗅觉失灵。”

 

医学专业人士可向美国FDA MedWatch项目组在线举报在使用此类产品过程中出现的不良事件或产品质量问题，或拨打热线1-800-FDA-1088，或传真1-800-FDA-0178，或下载已付邮资的FDA3500表格寄信至以下地址：5600 Fishers Lane, Rockville, MD 20852-9787。