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2009 Safety Alerts for Human Medical Products
(Drugs, Biologics, Medical Devices, Special Nutritionals, and Cosmetics)

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    Biologics - Special Nutritional Products and Cosmetics - Drugs and Therapeutic Biologics - Medical Devices

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Biologics (CBER):


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Special Nutritional Products and Cosmetics:


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Drugs and Therapeutic Biological Products (CDER):

Lidocaine (Posted 01/16/2009) New
Topical Anesthetics (Posted 01/16/2009) New

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Medical Devices:

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2009 Medical Product Safety Alerts, listed in reverse chronological order (most recent first). For an alphabetical listing, return to the categories on this page. You may also search the entire MedWatch site by keyword at the top of this Safety Information page.

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Topical Anesthetics
Audience: Consumers, radiological healthcare professionals, emergency room healthcare professionals, risk managers
[Posted 01/16/2009] FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.

[January 16, 2009 - Public Health Advisory - FDA]
[January 16, 2008 - Dear Colleague Letter - FDA] Adobe Acrobat [pdf] file

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