May be of interest if you work in general hospital at times.
Regards John

---------- Forwarded message ----------
From: CDER MEDWATCH LISTSERV <MEDWATCHLIST@...>
Date: 1 Oct 2007 20:55
Subject: FDA - MedWatch - Early Communication Issued Regarding Atrial
Fibrillation With Oral And Intravenous Bisphosphonates
To: MEDWATCH@...

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA issued an early communication about the ongoing review of new safety
data regarding the association of atrial fibrillation with the use of
bisphosphonates. Bisphosphonates are a class of drugs used primarily to
increase bone mass and reduce the risk for fracture in patients with
osteoporosis, slow bone turnover in patients with Paget's disease of the
bone, treat bone metastases, and lower elevated levels of blood calcium
in patients with cancer.

FDA reviewed spontaneous postmarketing reports of atrial fibrillation
reported in association with oral and intravenous bisphosphonates and
did not identify a population of bisphosphonate users at increased risk
of atrial fibrillation. In addition, as part of the data review for the
recent approval of once-yearly Reclast for the treatment of
postmenopausal osteoporosis, FDA evaluated the possible association
between atrial fibrillation and the use of Reclast. Most cases of atrial
fibrillation occurred more than a month after drug infusion. Also, in a
subset of patients monitored by electrocardiogram up to the 11th day
following infusion, there was no significant difference in the
prevalence of atrial fibrillation between patients who received Reclast
and patients who received placebo.

Upon initial review, it is unclear how these data on serious atrial
fibrillation should be interpreted. Therefore, FDA does not believe that
healthcare providers or patients should change either their prescribing
practices or their use of bisphosphonates at this time.

Read the complete MedWatch 2007 Safety Summary including a link to the
FDA Early Communication at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates

_________________________________________________________________

To ensure delivery of these timely alerts to your in-box and prevent
rejection of the notice by a spam filter, please add our MedWatch address,
MEDWATCH@..., to your address book.

Thank you for using FDA MedWatch as a trusted source for timely safety
information on drugs, devices and diagnostics regulated by the U.S. Food and
Drug Administration. If you find this e-mail notification helpful, please
consider telling colleagues and friends about MedWatch and this e-mail
notification process. They can learn more and subscribe to the e-list at
http://www.fda.gov/medwatch.

To send a comment or question to the MedWatch program:
http://www.fda.gov/medwatch/feedback.htm

To unsubscribe from this listserve:
https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1


--
Dr.J.Sullivan


[Non-text portions of this message have been removed]