FDA MedWatch

04/01/2008 -  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 April 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…