FDA NEWS

Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm...

Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product.

2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
Product recalled due to the presence of Burkholderia cepacia.

Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.

New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi...

Electronic Medical Devices
Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices.

April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with...

Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx
The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ...

Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.