Fda Med Watch

Published Nov 20, 2004

463 Posts

Following is latest email from FDA's medwatch system. Includes links and subscribing info if anyone is interested. (Timely delivery of info as it is released by FDA.)

There are 2 messages totalling 65 lines in this issue.

Topics of the day:

1. FDA MedWatch - Class 1 Recall of Access CardioSystems Automated E xternal

Defibrillators due to failure to deliver shock or unexpected shut off

2. FDA MedWatch - Depo-Provera Contraceptive Injection ( medroxyproge sterone

acetate injectable suspension) and loss of significant bone miner al

density

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Date: Fri, 19 Nov 2004 15:49:11 -0500

From: CDER MEDWATCH LISTSERV

Subject: FDA MedWatch - Class 1 Recall of Access CardioSystems Automated E xternal Defibrillators due to failure to deliver shock or unexpected shut off

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Access CardioSystems, Inc. notified the public of the Class 1 recall

of Access CardioSystems Automated External Defibrillators (AEDs), used for

the treatment of cardiac arrest by hospitals, fire departments and emergency

medical services personnel. Approximately 10,000 devices are in

distribution. One or both of the following problems may occur - 1] the

defibrillator may fail to deliver a shock due to a faulty circuit board, and

2] the defibrillator may turn on unexpectedly causing the "on/off" switch to

become inoperative, making the device unable to defibrillate. Customers

should immediately stop using the recalled devices.

Read the MedWatch 2004 safety summary, including a link to the FDA recall

notice and press release, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Access

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Date: Fri, 19 Nov 2004 15:54:44 -0500

From: CDER MEDWATCH LISTSERV

Subject: FDA MedWatch - Depo-Provera Contraceptive Injection ( medroxyproge sterone acetate injectable suspension) and loss of significant bone miner al density

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Pfizer notified healthcare professionals of the addition of a BOXED

WARNING along with revisions to the WARNINGS, INDICATIONS AND USAGE,

PRECAUTIONS and POSTMARKETING EXPERIENCE sections of the prescribing

information to include information on the loss of significant bone mineral

density. Depo-Provera Contraceptive Injection is indicated only for the

prevention of pregnancy in women of child-bearing potential. Bone loss is

greater with increasing duration of use and may not be completely

reversible. Depo-Provera Contraceptive should be used as a long-term birth

control method (eg, longer than 2 years) only if other birth control methods

are inadequate.

Read the MedWatch 2004 safety summary, including links to the "Dear