FDA MedWatch - Raptiva (efalizumab) - Withdrawn from market due to risk to patients of developing progressive multifocal leukoencephalopathy
Audience: Dermatological healthcare professionals, patients
Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.
Read the complete MedWatch 2009 Safety Summary, including links to the Dear Healthcare Professional letter, the Dear Patient letter and the FDA statement, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva
FDA MedWatch - ZOLL AED Plus Defibrillator: Recall because device may fail to deliver shock, could result in failure to resuscitate patient during sudden cardiac arrest
Audience: Emergency medical personnel
ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter at link below for details.
Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer letter at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#ZOLLAEDplus