Fw: Fwd: FDA MedWatch - The April 2008 FDA Patient Safety News Is Now Available

[Guest guest]

----- Forwarded Message ----From: "carwol@..." <carwol@...>

Have not had time to check out this newsletter, but have had letters from some of you who have found listings of warnings/recalls for medications that had been prescribed for them/family member ...but doctors had not given them any warning... We just never know do we --unless we check it out ourselves..Carolyn=============Date: Tue, 1 Apr 2008 09:58:01 -0500 (CDT)From: "U.S. Food & Drug Administration (FDA)" <fda@...>Subject: FDA MedWatch - The April 2008 FDA Patient Safety News Is Now Availablecarwol@...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_ [ 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 [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#1 ]_* FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed... *_Fentanyl (Duragesic) Patches Recalled [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#2 ]_* Gel leaks from defective patches may cause respiratory depression and death... *_New Safety Warnings about Chantix [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#3 ]_* Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug... *_Early Communication on Adverse Events from Botox and Myobloc [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#4 ]_* 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 [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#5 ]_* 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 [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#6 ]_* 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 [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#7 ]_* ISMP describes medication errors could result in dangerous hyper or hypo-glycemia... *_Caution Giving Children Cough and Cold Medicines [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=74#8 ]_* 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@... ________________________________________________________________________Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page [ https://service.govdelivery.com/service/user.html?code=USFDA ]. 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@.... This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ http://www.fda.gov/ ]. FDA [ http://www.fda.gov/ ] HHS [ http://www.hhs.gov/ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420=============