美國FDA警告:多款含Isoxazoline成分寵物除蚤劑,恐造成寵物癲癇

連結:美FDA警告 多款除蚤劑恐造成寵物癲癇

美國食品藥物管理局(FDA)周四警告,市售寵物除蚤劑恐造成寵物產生神經系統方面的不良反應,例如癲癇等。

美FDA表示,一種名叫Isoxazoline的化合物多添加於寵物除蚤劑中,可有效達到驅除跳蚤、壁蝨的功效,但有少部分寵物使用後,出現肌肉顫抖、無力和癲癇等神經系統方面的不良反應。

雖然如此,飼主們毋須恐慌,因為大部分的寵物於使用後皆沒有發生任何不良反應;但為了確保寵物健康,提醒飼主仍須檢視寵物的藥物史,並多觀察寵物的身體狀況。

美FDA提醒,市面上有多款除蚤劑,在選購上如有任何疑慮,可多與獸醫師討論,以找到最適合自家寵物的產品。若寵物於使用後發生上述的不適狀況,應諮詢獸醫師意見,並向除蚤劑製造商反映。

連結:Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products(美國FDA公告)

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class.

Since these products have obtained their respective FDA approvals, data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures. Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations.

The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products.

The FDA carefully reviewed studies and other data on Bravecto, Credelio, Nexgard and Simparica prior to approval, and these products continue to be safe and effective for the majority of animals. The agency is asking the manufacturers to make the changes to the product labeling in order to provide veterinarians and pet owners with the information they need to make treatment decisions for each pet on an individual basis. Veterinarians should use their specialized training to review their patients’ medical histories and determine, in consultation with pet owners, whether a product in the isoxazoline class is appropriate for the pet.


連結:寵物飼主「食」在「藥」小心 美國FDA公告驅蟲藥不良反應(2019/01/19)

美國FDA食品藥品監督管理局發出警告,部分含有Isoxazoline成分的口服驅蟲藥,可能會有導致狗兒神經失調的副作用,讓許多飼主憂心,對此高雄市獸醫師公會理事長高振庸表示,這也是他為何一再呼籲,為狗除寄生蟲絕對不可DIY,因為飼主若自行購買坊間除蟲藥為愛犬驅蟲,萬一用藥失當或是過量,狗兒可能一命嗚呼。

美國食品藥品監督管理局發出警告,指出含有 Isoxazoline的驅蟲藥可能會導致動物出現肌肉顫抖、癲癇或共濟失調等副作用。FDA直接點名了上市多年的口服驅蟲藥商,包括Bravecto(一錠除)、NexGard(全能狗)、Simparica(寵愛食剋),以及 FDA剛核准的 Credelio(台灣未販售)。

小編評:這個案子過了一年,還是有問題案例發生。

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