FDA MedWatch - July 2009 Patient Safety News now available

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Title: FDA MedWatch - July 2009 Patient Safety News now available
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the July 2009 edition include:

Warning on Testosterone Gel Products

Boxed warning and medication guide to highlight the risks of children being inadvertently exposed to testosterone…

Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps

To ensure the “up” and “down” buttons are working, verify the confirmation signal after each pump operation…

New Safety Information on Tarceva

Labeling revised to warn of gastrointestinal perforation, ocular disorders, and certain serious skin conditions…

Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products

Ceftriaxone (Rocephin and generics) and products containing calcium may now be administered within 48 hours of one another to patients over 28 days old, if certain precautions are followed…

Safety Problems with Denture Cleansers

Patients who use denture cleansers may suffer allergic reactions or mis-use these products…

Avoiding Infant Burns from Heel Warmers

First and second degree burns have been reported…

Avoiding Errors with Lamictal Starter Kits

To prevent over or underdosing, pharmacists should make sure the correct Lamictal starter kit has been prescribed to treat patients with epilepsy or bipolar disorder…

Warning on Accidental Ingestion of Benadryl Topical Gel

Packaging and labeling may contribute to patient mix-ups…


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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

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


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