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: Wed, 12 Mar 2008 05:54:20 -0500 (CDT)
Subject: CDRH New Update

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

Date: March 12, 2008

The following new items were added to the CDRH web pages on March 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

FDA Reminds Glucose Meter Users to Only Use Strips Recommended For Their Meter

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 12 Mar 2008 09:48:20 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 12 Mar 2008 15:04:52 -0500 (CDT)
Subject: FDA MedWatch - Prezista (darunavir)- Reports Of Drug Induced Hepatitis In Patients Receiving Prezista/Ritonavir

FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.

Read the complete 2008 MedWatch Safety Summaries including a link to the manufacturer's Dear Healthcare Professional Letter and Prescribing Information for Prezista concerning this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 12 Mar 2008 15:34:54 -0500 (CDT)
Subject: FDA MedWatch- Erythropoiesis Stimulating Agents- Studies Indicate Increased Mortality And More Rapid Tumor Progression In Patients With Cancer Receiving ESAs

Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.

Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:

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

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