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, 27 Feb 2008 08:48:02 -0600 (CST)
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: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Feb 2008 17:04:19 -0600 (CST)
Subject: FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
Wed, 27 Feb 2008 15:57:00 -0600

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 27 Feb 2008 13:18:06 -0600 (CST)
Subject: FDA MedWatch - FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury

Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and prescribing information for Tysabri at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri

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