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FDA Patient Safety News

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A Video News Show for Health Professionals. New broadcasts monthly, with online video and transcripts.
Updated: 24 min 54 sec ago

Recalls and Safety Alerts: Certain AQUA+FLEX Humidifiers Recalled

Thu, 07/01/2010 - 04:00
Teleflex Medical is recalling some of the company's AQUA+FLEX Hygroscopic Condenser Humidifiers. These devices are passive humidifiers used during mechanical ventilation to warm and humidify inspired gas. The company has received complaints that ...

Recalls and Safety Alerts: Recall of Shiley Cuffed Tracheostomy Tubes

Thu, 07/01/2010 - 04:00
Covidien is recalling some of the company's Shiley cuffed tracheostomy tubes because a leak in the pilot balloon assembly may cause the cuff to lose air. If a cuff does not stay inflated, a patient's ventilation could be compromised, which could lea...

Recalls and Safety Alerts: Using External Infusion Pumps Safely

Thu, 07/01/2010 - 04:00
External infusion pumps provide medications, fluids and nutrients to patients in healthcare facilities and in the home. They can improve patient care by delivering drugs and other substances with a high level of control, accuracy, and precision. But...

Preventing Medical Errors: Parent Errors in Measuring Children?s Doses

Thu, 07/01/2010 - 04:00
The Institute for Safe Medication Practices (ISMP) recently reported on a study of the errors parents make when measuring children's doses of oral medications. In the study, 300 parents were observed as they attempted to measure liquid doses using d...

Advice for Patients: Warning on Swallowing Benadryl Topical Gel

Thu, 07/01/2010 - 04:00
FDA is warning people not to swallow Benadryl Extra Strength Itch Stopping Gel, an OTC product that should only be used on the skin. FDA has received a number of reports where people experienced serious side effects after mistakenly swallowing t...

Advice for Patients: Warning about Lipodissolve Products

Thu, 07/01/2010 - 04:00
FDA is cautioning the public about products used in lipodissolve procedures. Lipodissolve is a cosmetic procedure where people are given a series of injections with the intent of dissolving pockets of fat in the body. The process, also known as lip...

New Medical Products: New Cellular Immunotherapy for Advanced Prostate Cancer

Thu, 07/01/2010 - 04:00
The FDA has approved a new therapy for certain men with advanced prostate cancer called Provenge (sipuleucel-T). Provenge, an autologous cellular immunotherapy, is manufactured by Dendreon Corporation. It is intended for men with asymptomatic or mi...

Recalls and Safety Alerts: Warning on Liver Injury with Propylthiouracil

Thu, 07/01/2010 - 04:00
In a new boxed warning, FDA is reminding healthcare professionals about the risk of serious liver injury, including liver failure and death, from propylthiouracil. This drug, which is used to treat hyperthyroidism, is considered second-line therapy ...

Recalls and Safety Alerts: Medication Guide Required for Vivitrol

Thu, 07/01/2010 - 04:00
The pharmaceutical company Alkermes has developed a Medication Guide for patients being treated with Vivitrol. Vivitrol (naltrexone for extended-release injectable suspension) is administered intramuscularly to treat alcohol dependence. The Medi...

New Medical Products: New Formulation for OxyContin

Tue, 06/01/2010 - 04:00
FDA has approved a new formulation of the controlled-release drug OxyContin that is designed to be more difficult to manipulate by someone trying to misuse or abuse the medication. OxyContin tablets contain the opioid analgesic oxycodone, which is r...

New Medical Products: First Absorbable Sealant Patch for Cardiovascular Surgery

Tue, 06/01/2010 - 04:00
FDA recently approved the first absorbable fibrin sealant patch to prevent bleeding from small blood vessels during cardiovascular surgery. The patch is called TachoSil and it is made by Nycomed. The patch provides an additional tool for surgeons t...

Recalls and Safety Alerts: Reduced Effect from Plavix in Some Patients

Tue, 06/01/2010 - 04:00
Through a new boxed warning, the FDA is alerting healthcare professionals about a subgroup of patients who cannot effectively metabolize the anti-platelet drug Plavix (clopidogrel). These patients, called "poor metabolizers," have little or no a...

Recalls and Safety Alerts: Muscle Injury from High Doses of Zocor

Tue, 06/01/2010 - 04:00
FDA is informing healthcare professionals that a preliminary review of a large clinical trial shows an increased risk of muscle injury in patients taking the highest dose of the statin drug simvastatin. Simvastatin is sold as Zocor, and is also an i...

Recalls and Safety Alerts: Companies to Stop Marketing Unapproved Nitroglycerin Tablets

Tue, 06/01/2010 - 04:00
FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dos...

Recalls and Safety Alerts: Boxed Warning for Exjade

Tue, 06/01/2010 - 04:00
Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade (deferasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from m...

Recalls and Safety Alerts: Hemolysis Risk with WinRho SDF

Tue, 06/01/2010 - 04:00
Baxter Healthcare and Cangene Corporation are notifying healthcare professionals that intravascular hemolysis (IVH), which can be fatal, has occurred in patients with immune thrombocytopenic purpura treated with WinRho SDF, an intravenous immune glob...

Preventing Medical Errors: Avoiding Problems with Temporary Cardiac Pacing

Tue, 06/01/2010 - 04:00
A recent FDA article in the journal Nursing2010 describes a variety of problems associated with temporary pacing leads. Temporary pacing is used during emergency treatment of some bradyarrhythmias and tachyarrhythmias, and also used prophylactically...

Advice for Patients: Caution about Sexual Enhancement Supplements

Tue, 06/01/2010 - 04:00
Your patients can easily find them on the internet --- products advertised as "dietary supplements" to enhance sexual performance or treat erectile dysfunction. Many of these products are said to be "all natural" alternatives to prescription drugs, ...

Advice for Patients: Phase-Out of CFC Inhalers

Tue, 06/01/2010 - 04:00
FDA is informing healthcare practitioners and patients that certain metered-dose inhalers used to treat asthma and chronic pulmonary obstructive disease will be gradually removed from the market because they use chlorofluorocarbons (CFCs) as propella...

New Medical Products: New Pneumococcal Vaccine for Children

Sat, 05/01/2010 - 04:00
FDA has approved a new pneumococcal vaccine that provides broader protection for infants and young children ages six weeks through five years. The new vaccine, called Prevnar 13, is effective against 13 serotypes of the bacterium Streptococcus pneum...
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