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: Tue, 1 Apr 2008 09:57:11 -0500 (CDT)
Subject: FDA MedWatch - The April 2008 FDA Patient Safety News Is Now Available

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 list serve. 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 A[pril 2008 edition include:

Decellularized Allograft Heart Valve Approved

FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed…

 

Fentanyl (Duragesic) Patches Recalled

Gel leaks from defective patches may cause respiratory depression and death…

 

New Safety Warnings about Chantix

Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug…

 

Early Communication on Adverse Events from Botox and Myobloc

Botulinum toxin may have spread beyond injection site and cause symptoms associated with botulism, including dysphagia and respiratory insufficiency…

 

New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch

Results of new study found women aged 15-44 who used the patch were at higher risk of developing venous thromboembolism than women using birth control pills…

 

Remembering to Re-Activate a Patients’s Defibrillator

A recent FDA article in Nursing2008 about a patient who died, possibly of ventricular fibrillation, following elective surgery because his ICD wasn't reactivated…

 

Mixups between Insulin U-100 and U-500

ISMP describes medication errors could result in dangerous hyper or hypo-glycemia… 

 

Caution Giving Children Cough and Cold Medicines

Ongoing evaluation of cough and cold medicines for children two and older…

 

For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@fda.gov

 

---

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