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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 06:06:27 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 16, 2008

The following new items were added to the CDRH web pages on June 13, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, June 12, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary
	Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports (Direct final rule).
	Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Companion to Direct Final Rule (Proposed rule).
	Consumer Information on: Stratos LV and Stratos LV T Cardiac Resynchronization Therapy Pacemakers and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads - P070008

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 15:06:17 -0500 (CDT)
Subject: FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
Mon, 16 Jun 2008 14:38:00 -0500

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 16 Jun 2008 15:51:21 -0500 (CDT)
Subject: FDA MedWatch- Antipsychotics Associated With An Increased Risk Of Mortality In Elderly Patients Treated For Dementia-Related Psychosis

FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics

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