New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients.

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

FDA Alert to Health Care Professionals

USP Heparin Information

Information for Consumers: What You Should Know about Changes to Heparin

National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities

http://www.diversitypreparedness.org/

The National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities, developed by the Drexel University School of Public Health’s Center for Health Equality, with support from the HHS Office of Minority Health.

This website provides information on preparedness in a variety of languages, including: Albanian, Amharic, Arabic, Armenian, Bengali, Bosnian, Brazilian, Burmese, Chamorro, Chinese, Chinese Simplified, Chinese Traditional, Chuukese, Croatian, Dutch, English, Ethiopian, Farsi, French, German, Haitian Creole, Hindi, Hmong, Italian, Japanese, Khmer/Cambodian, Kirundi, Korean, Kurdish, Laotian, Marshallese, Mien, Oromo, Persian, Polish, Portuguese, Russian, Samoan, Serbian, Sinhalese, Somali, Spanish, Sri Lanka, Swahili, Tagalog, Thai, Tongan, Turkish, Ukrainian, Urdu, Vietnamese, and Yupik.

International Clean Hands Week is Sept. 20-26, 2009

The Clean Hands Coalition (CHC) reminds healthcare professionals that International Clean Hands Week is Sept. 20-26, 2009. The Clean Hands Coalition is a unified alliance of public and private partners working together to create and support coordinated, sustained initiatives to significantly improve health and save lives through hand hygiene. The CHC is facilitated by the Centers for Disease Control and Prevention (CDC) For more information and ideas on how to celebrate this week by raising hand hygiene awareness, go to http://www.cleanhandscoalition.org/nchw.htm

Recall: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)

Audience: Emergency medical personnel, consumers

[Posted 09/16/2009] FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.

The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

[09/16/2009 - Recall Notice - FDA]

FDA ALERT: MYFORTIC

Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

Read the complete MedWatch Safety summmary at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm