U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Feb 2008 05:45:32 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 1, 2008

The following new items were added to the CDRH web pages on January 31, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Guidance for Industry and Food and Drug Administration Staff; Clinical Laboratory Improvement Amendments of 1988: Recommendations for Clinical Laboratory Improvement Amendments of 1988: Waiver Applications for Manufacturers of In Vitro Diagnostic Devices;
	Obstetrics and Gynecology Devices Panel Advisory Meeting, December 13-14, 2007 - Transcripts

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Feb 2008 12:04:22 -0600 (CST)
Subject: FDA Approves Drug-Eluting Stent for Clogged Heart Arteries

FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Fri, 1 Feb 2008 11:49:00 -0600

The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Feb 2008 14:10:18 -0600 (CST)
Subject: FDA Issues Public Health Advisory on Chantix

FDA Issues Public Health Advisory on Chantix
Fri, 1 Feb 2008 13:59:00 -0600

The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Feb 2008 19:04:00 -0600 (CST)
Subject: Cibo Naturals Issues Nationwide Allergy Alert on Undeclared Pine Nuts in Classic Basil Pesto (Feb. 1)

Cibo Naturals Issues Nationwide Allergy Alert on Undeclared Pine Nuts in Classic Basil Pesto (Feb. 1)
Fri, 1 Feb 2008 17:14:00 -0600

Cibo Naturals 6oz Classic Basil Pesto was distributed throughout the United States through retail grocery stores. The product is sold in 6oz clear plastic containers, under the label Cibo Naturals Classic Basil Pesto. The lot numbers that may contain undeclared pine nuts are 34007344, 34007345, and 34007346. This lot number information is printed in black ink on the bottom of the container.

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Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Feb 2008 14:11:54 -0600 (CST)
Subject: FDA MedWatch- Chantix (varenicline)-Associated With Reports Of Changes In Behavior, Agitation, Depressed Mood, Suicidal Ideation, and Attempted/Completed Suicide

FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients. 

Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Healthcare Professional Information Sheet and the prescribing information for Chantix regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline

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