For Immediate Release: June 16, 2009また米国食品医薬品局(FDA)は、勧告の中で、これらの製品に効果がないと述べている。
FDA Advises Consumers Not To Use Certain Zicam Cold Remedies
Intranasal Zinc Product Linked to Loss of Sense of Smell
以下のZicamの風邪レメディの使用しないように勧告
鼻腔内投与する亜鉛製品は嗅覚の喪失と関連あり
The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.
米国食品医薬品局(FDA)は今日(2009/06/16)付で、風邪のレメディとして一般市販薬として販売されている3つの製品の使用をやめるように勧告を出した。これは、これらの製品が嗅覚の喪失と関連性があるかである。嗅覚喪失は長期にわたって回復しないか、恒久的に回復しない。
The products are:（該当製品）
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product)
The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people 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.
米国食品医薬品局(FDA)は、上記3種のZicam製品を使用して嗅覚を喪失したという報告を130以上、受け取った。これらの報告によれば、多くの人々が初回の使用で、嗅覚を喪失している。また、他の人々は複数回の使用後に嗅覚を喪失している。
“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”
米国食品医薬品局(FDA)の薬品試験センター(CDER)のセンター長であるM.D. Janet Woodcockは「嗅覚の喪失は風邪の症状に対して、これらの製品を使う人々にとって重大なリスクとなる。人々がリスクを知らずに使用して、重大な被害を受けないか懸念している。したがって、我々はいかなる理由があろうとも、これらの製品を使用しないように勧告する。」と述べた。
People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.
Zicamを使用して嗅覚の喪失など起こした場合は、医者に相談すること。嗅覚の喪失はクォリティ・オブ・ライフに悪影響を及ぼし、ガス漏れや火災の焦げ臭さや、環境中の危険を検知する能力を弱める。
The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.
米国食品医薬品局(FDA)はZicam製品を販売するMatrixx Initiativesに対して、FDAの認可を受けずに、これらの製品を販売しないように警告した。
“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.
Loss of Sense of Smell with Intranasal Cold Remedies Containing Zincさらに、発売元であるMatrixx Initiatives, Inc.社(通称 AKA Zicam LLC）に送られた警告で、米国食品医薬品局(FDA)は製品パッケージの説明は、これらの製品が医薬品に該当しており、審査を受けずに販売してはならないと述べている：
Zincを含有した鼻腔内投与の風邪レメディによる嗅覚喪失
June 16, 2009
FDA is alerting consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size, a discontinued product that consumers may still have in their homes, have all been associated with long lasting or permanent loss of smell (referred to as anosmia). These products, marketed by Matrixx Initiatives, are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms. However, these products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.
米国食品医薬品局(FDA)は消費者に対して、Zicam Cold Remedy Nasal GelおよびZicam Cold Remedy Nasal SwabsならびにZicam Cold Remedy Swabs, Kids Size(このkids sizeのみ生産中止されているが、消費者がまだ家庭に持っている可能性がある)はすべて、長期にわたって回復しないか恒久的に回復しない嗅覚喪失と関連性がある。 Matrixx Initiativesが販売しているこれらの製品は亜鉛を含有した鼻風邪レメディで、風邪の期間短縮および症状を緩和するために使われる。しかし、これらの製品が風邪の期間短縮や症状緩和に有効だとは示されていない。
This advisory does not concern oral zinc tablets and lozenges taken by mouth.
この勧告には、口から服用する亜鉛タブレットや薬用ドロップは該当しない。
FDA recommends that consumers stop using these products and throw them away.
米国食品医薬品局(FDA)はこれらの製品の使用と取り止めて、破棄するように推奨する。
...[強調追加]
According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products “reduces” the “duration of the common cold” and the “severity of cold symptoms,” including specifically “sore throat • stuffy nose •sneezing • coughing • congestion.” These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.なお、製品パッケージはこれ：
We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling.[1] On the contrary, as described below, there is evidence that these products pose a serious safety risk to consumers. Because they are not generally recognized as safe and effective for their labeled uses, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA‑approved application is in effect for it. There are no approved new drug applications (NDAs) on file with FDA for any of the Zicam Cold Remedy intranasal products; you market them without FDA approval.
[WARNING LETTER: Matrixx Initiatives, Inc. AKA Zicam LLC 6/16/09]
もし、個人輸入などで入手していた場合は、ただちに破棄すべき。
http://www.zicam.com/HomeopathyandZicam
"Regarding questions from consumers as to whether Zicam Cold Remedy products are really homeopathic, let me simply state, yes, they are."