Patient Safety at Regulatory Affairs Syndicator

Archive for the 'Patient Safety' Category

Recalls and Safety Alerts: Recall of ACCU-CHEK Ultraflex Infusion Sets

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

Disetronic Medical Systems is recalling all ACCU-CHEK Ultraflex infusion sets, which are used with insulin pumps, because the set’s tubing could separate at the luer lock connection. This could cause a leakage of insulin, resulting in hyperglycemia….

Recalls and Safety Alerts: Anaphylaxis with Macugen

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

Pfizer Pharmaceuticals has alerted healthcare professionals that severe allergic reactions have occurred in patients treated with Macugen. Macugen (pegaptanib sodium injection) is used to slow vision loss in people with the neovascular or ?wet? form…

Recalls and Safety Alerts: New Information on Preventing Patient Entrapment in Hospital Beds

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

FDA has received hundreds of reports of deaths and injuries in patients who became entrapped in hospital beds-sometimes through the bars of a side rail, or through the space between split side rails, or between the bed rail and the mattress, the head…

Recalls and Safety Alerts: Importance of Monitoring Liver Function with Tracleer

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

Based on recent reports of hepatotoxicity, the drug company Actelion has reminded healthcare professionals about the importance of monitoring liver function in patients receiving Tracleer (bosentan).

Tracleer is a limited-access drug that’s us…

Recalls and Safety Alerts: Accidental Intrathecal Administration of IV Vincristine

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

A recent Institute for Safe Medication Practices safety alert warns about the danger of accidentally administering IV vincristine by the intrathecal route. ISMP cites a recent case where a syringe containing vincristine was accidentally delivered to…

Preventing Medical Errors: Dangerous Confusion with Color-coded Wristbands

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

A recent ISMP report, along with an advisory from the Pennsylvania Patient Safety Authority, points out the danger of misinterpreting the meaning of color-coded wristbands worn by patients. The confusion is often caused by certain colors having diff…

New Medical Products: IMPORTANT NEW INFORMATION — on Natalizumab (marketed as Tysabri)

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

IMPORTANT NEW INFORMATION (June 5, 2006)

FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing fo…

Recalls and Safety Alerts: Dangerous Contamination of Certain Balanced Salt Solutions

Closed Published by Food and Drug Adminstration (FDA): Patient Safety April 30th, 2006 in Patient Safety, Regulatory Affairs

FDA is alerting health care professionals that dangerous levels of endotoxins have been found in certain brands of balanced salt solution. These solutions are used to irrigate the eyes, nose and throat during a variety of surgical procedures, includi…

New Medical Products: FDA Approves Emsam - First Drug Patch for Depression

Closed Published by Food and Drug Adminstration (FDA): Patient Safety April 30th, 2006 in Patient Safety, Regulatory Affairs

FDA recently approved the first transdermal drug patch for treating major depressive disorder. The patch, called Emsam and marketed by Bristol-Myers Squibb, is applied once a day to deliver the drug selegeline, an MAO inhibitor.

MAO inhibitors …

The advisory was based on two recently publi…

Recalls and Safety Alerts: Erythropoietic Agents and Antibody-Mediated Anemias

Closed Published by Food and Drug Adminstration (FDA): Patient Safety April 30th, 2006 in Patient Safety, Regulatory Affairs

The manufacturers of the erythropoietic agents Procrit, Aranesp and Epogen have provided updated information about certain antibody-mediated reactions in patients treated with these drugs.

Patients taking these drugs can produce antibodies to er…