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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 05:51:18 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 4, 2008

The following new items were added to the CDRH web pages on June 2, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments.
	Federal Register: Medical Devices; Hearing Aids; Technical Data Amendments.

---

Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 09:18:30 -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.

---

Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 4 Jun 2008 14:54:25 -0500 (CDT)
Subject: FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults

FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF) Blockers regarding this issue at:

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

---

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420