FDA MedWatch - July 2010 FDA Patient Safety News now available
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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 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 clinicians and educators in healthcare facilities and academic institutions.
Stories in the July 2010 edition include:
New Cellular Immunotherapy for Advanced Prostate Cancer
Provenge is designed to stimulate the patient’s immune system to respond against the cancer…
Warning on Liver Injury with Propylthiouracil
New boxed warning highlights that propylthiouracil should be reserved for patients who cannot tolerate methimazole, radioactive iodine or surgery…
Medication Guide Required for Vivitrol
New medication guide, which highlights potential side effects and what to avoid during treatment, should be given to patients before each Vivitrol injection…
Certain AQUA+FLEX Humidifiers Recalled
The humidifier's flex tube connector could become disconnected from the endotracheal tube…
Recall of Shiley Cuffed Tracheostomy Tubes
A leak in the pilot balloon assembly may cause the cuff to lose air, which may compromise the patient’s ventilation...
Using External Infusion Pumps Safely
Recommendations for clinicians to reduce infusion pump-related risks…
Parent Errors in Measuring Children’s Doses
The Institute for Safe Medication Practices reported on a study that showed parents made more errors with dosing cups than with other measuring devices…
Warning on Swallowing Benadryl Topical Gel
To help prevent mix-ups, the front of the bottle and bottle cap now says “For Skin Use Only”…
Warning about Lipodissolve Products
FDA has not approved any injectable drug to eliminate fat, and the safety of these products, used alone or in combination is unknown…
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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