Patient Safety at Regulatory Affairs Syndicator

Archive for the 'Patient Safety' Category

New Medical Products: Decellularized Allograft Heart Valve Approved

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recove…

Recalls and Safety Alerts: Fentanyl (Duragesic) Patches Recalled

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

Several brands of fentanyl transdermal patches are being recalled because they may have defects that could allow the fentanyl gel to leak out of the patch. If the gel touches patient’s or caregiver’s skin, it could cause respiratory depression and p…

Recalls and Safety Alerts: New Safety Warnings about Chantix

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA is alerting healthcare professionals about new safety warnings for Chantix (varenicline), a drug used to help people stop smoking.

Chantix has been linked to serious neuropsychiatric problems, including changes in behavior, agitation, depres…

Recalls and Safety Alerts: Early Communication on Adverse Events from Botox and Myobloc

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product w…

Recalls and Safety Alerts: New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher…

Preventing Medical Errors: Remembering to Re-Activate a Patients?s Defibrillator

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

A recent FDA article in the journal “Nursing2008″ describes the case of a patient who died, possibly of ventricular fibrillation, following elective surgery. This happened because after the procedure, his implantable cardioverter defibrillator (ICD)…

Preventing Medical Errors: Mixups between Insulin U-100 and U-500

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

The Institute for Safe Medication Practices (ISMP) recently described an increase in reports about mixups between insulin U-100 and insulin U-500. These errors could result in dangerous hyperglycemia or hypoglycemia. Mistakes have occurred when pre…

Patients Are Asking: Caution Giving Children Cough and Cold Medicines

Closed Published by Food and Drug Adminstration (FDA): Patient Safety March 31st, 2008 in Patient Safety, Regulatory Affairs

FDA is cautioning parents and caregivers about giving their children cough and cold medicines.

FDA strongly recommends that cough and cold medicines NOT be given to children younger than 2 years old because serious and potentially life-threateni…

Recalls and Safety Alerts: New Studies on Antidepressants in Pregnancy

Closed Published by Food and Drug Adminstration (FDA): Patient Safety October 31st, 2006 in Patient Safety, Regulatory Affairs

In a recent Public Health Advisory, FDA summarized two new studies that practitioners should consider when making decisions about prescribing SSRIs and other antidepressant medications for pregnant women and those planning a pregnancy.

The first…

Recalls and Safety Alerts: Safety Information on Alaris SE Infusion Pumps

Closed Published by Food and Drug Adminstration (FDA): Patient Safety October 31st, 2006 in Patient Safety, Regulatory Affairs

Cardinal Health, the owner of Alaris Products, has recalled all models of the Alaris Signature Edition (or SE) infusion pumps. These pumps have a design defect called “key bounce” that may cause over-infusion of medications. The affected models are…

Recalls and Safety Alerts: Increased Risk of Infectious Disease Transmission from Human Tissues recovered by Donor Referral Services

Closed Published by Food and Drug Adminstration (FDA): Patient Safety October 31st, 2006 in Patient Safety, Regulatory Affairs

FDA is notifying healthcare professionals that certain human tissues used in patients may have an increased risk for transmitting infectious diseases. These tissues, including human bone and soft tissue such as tendons, came from a tissue recovery c…