FDA Notice: Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Read the MedWatch 2009 safety summary, including a link to the Recall Notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Colleague

The importance of patient identification cards

In mid-November 2008, the Kidney Community Emergency Response (KCER) Coalition mailed out lavender-colored patient identification cards to all dialysis facilities. The purpose of these cards is to assist in identifying a dialysis patient to emergency management, special needs shelter staff, and law enforcement that the individual needs access to treatment. Additionally, these cards provide a space for the local ESRD Network patient hotline, and other spaces for critical emergency information.

For more about the lavender patient cards or to print more cards, please visit http://www.kcercoalition.com/lavender.htm

FDA Notice: CellCept

As directed, the Kidney Community Emergency Response (KCER) Coalition is providing this alert notice. Please share this information with your organization’s stakeholders, ESRD Network (facilities, patients), your State Agency contacts, and your staff. These notices will also be posted on the KCER website, http://www.kcercoalition.com/alerts.htm. Thank you!

CellCept (mycophenolate mofetil)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept

CDC lanches SNAPS: Snap Shots of State Population Data

http://emergency.cdc.gov/snaps/

SNAPS provides local-level community profile information nationwide. It can be browsed by county and state and searched by zip code. SNAPS serves as a valuable tool when responding to public health emergency events at the state, Tribal, and local levels. It provides a "snap shot" of key variables for consideration in guiding and tailoring health education and communication efforts to ensure diverse audiences receive critical public health messages that are accessible, understandable, and timely.

SNAPS data is derived from the 2000 US Census and several 2003 CDC databases. For more information, see Credits.

FDA Alert: Innohep (12/31/08)

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep